Handheld eye imaging system

Abstract

A handheld eye imaging system which may be useful for capturing magnified and in-focus images of target structures of the eye, whereby the eye imaging system includes a magnifying lens housed within a housing having a housing proximal end and an opposing housing distal end, a light source housed within the housing, and a subject interface coupled to the housing proximate the housing distal end. The housing can be configured to removably couple to a portable camera proximate the housing proximal end. The camera can include a camera lens with a camera lens optical axis, whereby upon coupling of the housing and the camera, the magnifying lens may dispose along the camera lens optical axis.

Description

[0001] 1133P01T

[0002] HANDHELD EYE IMAGING SYSTEM

[0003] This International Patent Cooperation Treaty Patent Application claims the benefit of United States Provisional Patent Application No. 63 / 716,396, filed November 5, 2024, hereby incorporated by reference herein.

[0004] I. DISCLOSURE OF THE INVENTION

[0005] A broad object of the present invention can be to provide embodiments of a handheld eye imaging system which may be useful for capturing magnified and in-focus images of target structures of the eye, whereby the eye imaging system includes a magnifying lens housed within a housing having a housing proximal end and an opposing housing distal end, a light source housed within the housing, and a subject interface coupled to the housing proximate the housing distal end. The housing can be configured to removably couple to a portable camera proximate the housing proximal end. The camera can include a camera lens with a camera lens optical axis, whereby upon coupling of the housing and the camera, the magnifying lens may dispose along the camera lens optical axis.

[0006] Naturally, further objects of the invention are disclosed throughout other areas of the specification, drawings, photographs, and claims.

[0007] II. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1A shows an image of an eye with a nuclear sclerosis grade II cataract captured with a mobile computing device configured as a smartphone.

[0009] Figure IB shows an image of the same eye in Figure 1 A captured with an embodiment of the eye imaging system including a bi-convex magnifying lens with a focal length of about 30 mm.

[0010] Figure 1C shows an image of the same eye in Figure 1A captured with an embodiment of the eye imaging system including an intraocular lens with a power of about 10 diopters.

[0011] Figure 2A is a perspective view of a particular embodiment of an optical assembly of the eye imaging system coupled to a case which may be used with a mobile computing device, such as a smartphone. 1133P01T

[0012] Figure 2B is a front view of the optical assembly shown in Figure 2A.

[0013] Figure 2C is a rear view of the optical assembly shown in Figure 2A.

[0014] Figure 2D is a first side view of the optical assembly shown in Figure 2A.

[0015] Figure 2E is a second side view of the optical assembly shown in Figure 2A.

[0016] Figure 2F is a top view of the optical assembly shown in Figure 2A.

[0017] Figure 2G is a bottom view of the optical assembly shown in Figure 2A.

[0018] Figure 3 is an exploded perspective view of the optical assembly shown in Figures 2A through 2G.

[0019] Figure 4A shows an image of an eye with an immature cataract captured with an embodiment of the eye imaging system including a bi-convex lens.

[0020] Figure 4B shows an image of the same eye in Figure 4A captured with an embodiment of the eye imaging system including an intraocular lens.

[0021] Figure 5 A shows an image of a light-colored eye captured with an embodiment of the eye imaging system including a white light source having a color temperature of about 6,000 K and a viewing angle of about 60°.

[0022] Figure 5B shows an image of the same eye in Figure 5A captured with an embodiment of the eye imaging system including a white light source having a color temperature of about 4,000 K and a viewing angle of about 120°.

[0023] Figure 5C shows an image of a dark-colored eye captured with an embodiment of the eye imaging system including a white light source having a color temperature of about 6,000 K and a viewing angle of about 60°. 1133P01T

[0024] Figure 5D shows an image of the same eye in Figure 5C captured with an embodiment of the eye imaging system including a white light source having a color temperature of about 4,000 K and a viewing angle of about 120°.

[0025] Figure 6A shows an image of an eye with a cataract captured with an embodiment of the eye imaging system including two white light sources positioned in vertically-aligned spaced-apart relation.

[0026] Figure 6B shows an image of the same eye in Figure 6A captured with an embodiment of the eye imaging system including two white light sources positioned in horizontally-aligned spaced-apart relation.

[0027] Figure 6C shows an image of the same eye in Figure 6A captured with an embodiment of the eye imaging system including two white light sources positioned in vertically-aligned spaced- apart relation and two white light sources positioned in horizontally-aligned spaced-apart relation.

[0028] Figure 6D shows an image of an eye with a cataract captured with an embodiment of the eye imaging system including one white light source positioned on the temporal side of the eye.

[0029] Figure 6E shows an image of the same eye shown in Figure 6D captured with an embodiment of the eye imaging system including one white light source positioned on the nasal side of the eye.

[0030] Figure 7A shows an image of an eye with a clear lens captured with an embodiment of the eye imaging system including two white light sources positioned in horizontally-aligned spaced- apart relation and disposed about 18 mm apart.

[0031] Figure 7B shows an image of the same eye in Figure 7A captured with an embodiment of the eye imaging system including two white light sources positioned in horizontally-aligned spaced-apart relation and disposed about 25 mm apart.

[0032] Figure 8A shows an image of an eye with a mature cataract captured with an embodiment of the eye imaging system. 1133P01T

[0033] Figure 8B shows an image of an eye with an immature cataract captured with an embodiment of the eye imaging system.

[0034] Figure 8C shows an image of a pseudophakic eye captured with an embodiment of the eye imaging system.

[0035] Figure 8D shows an image of an eye with a pterygium captured with an embodiment of the eye imaging system.

[0036] Figure 8E shows an image of an eye with infectious keratitis captured with an embodiment of the eye imaging system.

[0037] Figure 9A shows an image of an eye with a nuclear sclerosis grade II cataract captured with an embodiment of the eye imaging system including two white light sources positioned in vertically-aligned spaced-apart relation and disposed about 12 mm from the eye.

[0038] Figure 9B shows an image of the same eye in Figure 9A captured with an embodiment of the eye imaging system including two white light sources positioned in vertically-aligned spaced- apart relation and disposed about 15 mm from the eye.

[0039] Figure 10 shows an image of an eye with infectious keratitis captured with an embodiment of the eye imaging system including blue light, whereby the eye is stained with fluorescein stain.

[0040] Figure 11 A shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0041] Figure 1 IB shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0042] Figure 11C shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0043] Figure 1 ID shows a particular embodiment of a light source configuration which may be used with the optical assembly. 1133P01T

[0044] Figure 1 IE shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0045] Figure 1 IF shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0046] Figure 11G shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0047] Figure 11H shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0048] Figure 111 shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0049] Figure 11 J shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0050] Figure 1 IK shows a particular embodiment of a light source configuration which may be used with the optical assembly.

[0051] Figure 12A is a perspective view of a particular embodiment of a PCB including light sources which may be used with the optical assembly.

[0052] Figure 12B is a front view of the PCB shown in Figure 12A.

[0053] Figure 12C is a rear view of the PCB shown in Figure 12A.

[0054] Figure 13 A is a first perspective view of a particular embodiment of a pupil centration system which may be used with the optical assembly.

[0055] Figure 13B is a second perspective view of the pupil centration system shown in Figure 13A.

[0056] Figure 13C is a front view of the pupil centration system shown in Figure 13A. 1133P01T

[0057] Figure 13D is a rear view of the pupil centration system shown in Figure 13 A.

[0058] Figure 13E is a top view of the pupil centration system shown in Figure 13 A.

[0059] Figure 13F is a bottom view of the pupil centration system shown in Figure 13 A.

[0060] Figure 14 shows an image of an eye with alignment guides for eye and pupil centration provided by software, whereby the alignment guides overlay the image.

[0061] Figure 15 shows an image of an eye with adaptive alignment provided by software, whereby cues such as arrows and colors may be used to provide feedback to the user regarding alignment.

[0062] Figure 16 shows an image of an eye with focus guides provided by software, whereby the focus guides overlay the image.

[0063] Figure 17 shows an exemplary user interface which combines alignment guides and focus guides, whereby in this image, the eye is aligned, the pupil is not centered, and the eyelashes are in focus.

[0064] Figure 18 shows an exemplary user interface which combines alignment guides and focus guides, whereby in this image, the eye is aligned, the pupil is centered, and the iris plane is in focus.

[0065] Figure 19A is a perspective view of a particular embodiment of a slit lamp coupled to a case which may be used with a mobile computing device, such as a smartphone.

[0066] Figure 19B is a front view of the slit lamp shown in Figure 19A.

[0067] Figure 19C is a bottom view of the slit lamp shown in Figure 19A.

[0068] Figure 20A is a perspective view of a particular embodiment of just the slit lamp shown in Figures 19A through 19C. 1133P01T

[0069] Figure 20B is a front view of the slit lamp shown in Figure 20A.

[0070] Figure 20C is a bottom view of the slit lamp shown in Figure 20A with hidden lines.

[0071] Figure 21A is a perspective view of a particular embodiment of a slit lamp coupled to a case which may be used with a mobile computing device, such as a smartphone.

[0072] Figure 21B is a front view of the slit lamp shown in Figure 21 A.

[0073] Figure 21C is a bottom view of the slit lamp shown in Figure 21 A with hidden lines.

[0074] Figure 22 shows an image of an eye with an immature cataract captured with an embodiment of the eye imaging system.

[0075] Figure 23A is a perspective view of a particular embodiment of the eye imaging system including a slit lamp coupled to the optical assembly shown in Figures 2A through 2G.

[0076] Figure 23B is a front view of the eye imaging system shown in Figure 23 A.

[0077] Figure 23C is a rear view of the eye imaging system shown in Figure 23 A.

[0078] Figure 23D is a first side view of the eye imaging system shown in Figure 23 A.

[0079] Figure 23E is a second side view of the eye imaging system shown in Figure 23 A.

[0080] Figure 23F is a top view of the eye imaging system shown in Figure 23 A.

[0081] Figure 23G is a bottom view of the eye imaging system shown in Figure 23 A.

[0082] Figure 24 is an exploded perspective view of the eye imaging system shown in Figures 23 A through 23 G.

[0083] Figure 25 is an exploded perspective view of the housing of the optical assembly, the PCB of the optical assembly, and the slit lamp of the eye imaging system shown in Figures 23 A through 23 G. 1133P01T

[0084] Figure 26 is a bottom view of the slit lamp shown in Figure 23G with hidden lines.

[0085] Figure 27A is a perspective view of a particular embodiment of an optical assembly of the eye imaging system coupled to a case which may be used with a mobile computing device, such as a smartphone.

[0086] Figure 27B is a front view of the optical assembly shown in Figure 27A.

[0087] Figure 27C is a rear view of the optical assembly shown in Figure 27A.

[0088] Figure 27D is a first side view of the optical assembly shown in Figure 27A.

[0089] Figure 27E is a second side view of the optical assembly shown in Figure 27A.

[0090] Figure 27F is a top view of the optical assembly shown in Figure 27A.

[0091] Figure 27G is a bottom view of the optical assembly shown in Figure 27A.

[0092] Figure 28 is an exploded perspective view of the optical assembly shown in Figures 27A through 27G.

[0093] III. MODE(S) FOR CARRYING OUT THE INVENTION

[0094] Disclosed herein are various embodiments of a novel handheld ophthalmic or eye imaging system which can be useful for capturing one or more images (whether still captures or videos) of the eye of a subject and especially, magnified and in-focus images of one or more target structures of the eye. As to particular embodiments, the eye imaging system can include a magnifying lens (1) housed within a housing (2) having a housing proximal end (3) and an opposing housing distal end (4), a light source (5) housed within the housing (2), and a subject interface (6) coupled to the housing (2) proximate the housing distal end (4). The housing (2) can be configured to removably couple to a portable camera proximate the housing proximal end (3). The camera can include a camera lens with a camera lens optical axis, whereby upon coupling of the housing (2) and the camera, the magnifying lens (1) may dispose along the camera lens optical axis. 1133P01T

[0095] To illustrate the present eye imaging system, Figure 1 A shows an image of an eye with a nuclear sclerosis grade II cataract captured with a mobile computing device configured as a smartphone, whereby Figure IB shows an image of the same eye in Figure 1 A captured with an embodiment of the eye imaging system including a bi-convex magnifying lens (1) with a focal length of about 30 mm and Figure 1C shows an image of the same eye in Figure 1 A captured with an embodiment of the eye imaging system including an intraocular lens with a power of about 10 diopters.

[0096] As used herein, the imaged eye is of a subject whereby the term “subject” can be inclusive of any subject, whether human or animal, whose eye may be imaged with the eye imaging system. The term “user” can refer to the person who operates the eye imaging system to capture the images of the subject’s eye. As to particular embodiments, the subject can also be the user for self-imaging.

[0097] Component-wise, the magnifying lens (1), the light source (5), the housing (2), and the subject interface (6) can constitute an optical assembly (7) which may be configured to removably couple to a camera to provide the eye imaging system. Conveniently, the eye imaging system, including both the optical assembly (7) and the camera, can be portable, whereby as used herein, the term “portable” may mean relatively easily carried or moved, especially by hand; a synonym for portable can be mobile. Such portability can permit use of the eye imaging system both within and outside of a clinical setting, such as in a remote location. Additionally, use of the eye imaging system can be relatively simple and intuitive with a low skill barrier, thus allowing both trained eye care providers as well as those not trained in eye care provision to successfully capture effective images of the eye. Further, the eye imaging system can be relatively affordable and / or inexpensive, accordingly minimizing a potential cost barrier to acquisition and use.

[0098] Magnifying Lenses

[0099] Now referring primarily to Figures 2A through 3, the optical assembly (7) includes one or more lenses (1) housed within the housing (2), whereby as used herein, the term “lens” can mean a generally transparent object which refracts or bends light as it passes therethrough to generate an image. The lens (1) can cooperate with the camera lens of the camera to focus on and capture images of target structures associated with ocular anatomy and pathology.

[0100] As to particular embodiments, the target structures can be those of the anterior segment of the eye, the sclera, the conjunctiva, or periocular regions, whereby the anterior segment is the 1133P01T frontmost part of the globe and includes the cornea, the anterior chamber, the iris, and the eye lens. For effective imaging thereof, the lens (1) can be a magnifying lens (1) which may magnify the target structures to make them appear larger than they are, thereby facilitating their observation and examination. Notably, whilst magnification can be necessary for such observation and examination, due to the extended depth of field and curved surface of the anterior segment, capturing magnified images in which the target structures are in-focus may be difficult. Variations in subject anatomy can also shift the focal plane. Beneficially, the present eye imaging system effectively addresses these as well as other challenges. For example, the magnifying lens (1) can be specifically positioned and its parameters may be selected to facilitate focus on the cornea, iris, and eye lens planes with a sufficient depth of field for ease-of-use while providing effective magnification for visualization of anatomy and pathology.

[0101] Regarding position, upon coupling of the optical assembly (7) to the camera, the magnifying lens (1) can dispose along the camera lens optical axis. As to particular embodiments, upon coupling, a magnifying lens optical axis (8) of the magnifying lens (1) can be coaxial with the camera lens optical axis; said another way, the magnifying lens (1) and the camera lens may have coincident optical axes. To generate an in-focus image (which can mean that the image may be clear and sharp with easily discernible details), the eye imaging system can be positioned to locate the target structures along the coincident magnifying lens optical axis (8) and camera lens optical axis such that light rays from the target structures converge substantially precisely on the sensor of the camera which captures light and converts it into an electrical signal to provide an image.

[0102] Upon coupling of the optical assembly (7) to the camera, the magnifying lens (1) can dispose a relatively short distance from the camera lens. As for cameras which have more than one camera lens or multiple camera lenses, the magnifying lens (1) can dispose a relatively short distance from the outermost camera lens, meaning the camera lens farthest from the sensor of the camera. The distance between the magnifying lens (1) and the camera lens can be dictated, at least in part, by the diameter of the magnifying lens (1) and / or the focal length of the magnifying lens (1), whereby the latter may directly relate to the magnification of the magnifying lens (1). Specifically, the shorter the focal length of the magnifying lens (1), the greater the magnification of the magnifying lens (1).

[0103] Optical Lenses 1133P01T

[0104] As to particular embodiments, the magnifying lens (1) can be configured as an optical lens, such as an aspherical optical lens or a spherical optical lens, as further detailed below. Upon coupling of the optical assembly (7) to the camera, the magnifying lens (1) can dispose about 2 millimeters (mm) to about 50 mm from the camera lens.

[0105] As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 45 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 40 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 35 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 30 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 25 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 20 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 15 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 2 mm to about 10 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose about 3 mm to about 10 mm from the camera lens.

[0106] As to particular embodiments, the magnifying lens (1) can dispose not greater than about 50 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 45 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 40 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 35 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 30 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 25 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 20 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 15 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 10 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 7.5 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose not greater than about 5 mm from the camera lens. As to particular embodiments, the magnifying lens (1) can dispose less than about 10 mm from the camera lens. As but one illustrative example, the magnifying lens (1) can dispose about 4 mm from the camera lens along the camera lens optical axis. 1133P01T

[0107] The magnifying lens (1) can have a diameter which may be greater than the aperture diameter of the camera such that the magnifying lens (1) fully covers the camera’s aperture. As to particular embodiments, the diameter of the magnifying lens (1) can be at least about 20% greater than the aperture, which may facilitate minimization of peripheral aberrations. For effective imaging, the magnifying lens (1) can have a diameter of about 6 mm to about 50 mm. As but one illustrative example, the magnifying lens (1) can have a diameter of about 12.7 mm (about 0.5 inches).

[0108] The magnifying lens (1) can have a central thickness of about 2 mm to about 18 mm. As to particular embodiments, the magnifying lens (1) can have a central thickness of about 2 mm to about 10 mm. As to particular embodiments, the magnifying lens (1) can have a central thickness of about 3 mm to about 6 mm.

[0109] For effective imaging, the magnifying lens (1) can have a focal length of about 15 mm to about 80 mm, whereby the depth of field of the magnifying lens (1) can relate thereto. Specifically, the shorter the focal length of the magnifying lens (1), the smaller (shallower) the depth of field of the magnifying lens (1).

[0110] As to particular embodiments, the magnifying lens (1) can have a focal length of about 15 mm to about 70 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 15 mm to about 60 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 15 mm to about 50 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 20 mm to about 50 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 20 mm to about 45 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 20 mm to about 40 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 20 mm to about 35 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 20 mm to about 30 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 25 mm to about 50 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 30 mm to about 50 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 35 mm to about 50 mm. As to particular embodiments, the magnifying lens (1) can have a focal length of about 40 mm to about 50 mm. 1133P01T

[0111] Regarding material, the magnifying lens (1) can be made from an optical substrate, such as but not limited to N-BK7, BK10, N-SF11, UV fused silica, S-LAH64, calcium fluoride, other crown glasses, and the like. As but one illustrative example, the magnifying lens (1) can be made from N-BK7, which may have high transmission, low dispersion, and good resistance to environmental factors; also, N-BK7 can be widely available, making it a cost-effective option.

[0112] The material from which the magnifying lens (1) is made can determine its index of refraction. For the present magnifying lens (1), materials with a refractive index of about 1.4 to about 1.9 can be particularly suitable. As but one illustrative example, a magnifying lens (1) made from N-BK7 can have a refractive index of about 1.517.

[0113] The magnifying lens (1) can be uncoated or coated, depending upon the embodiment. An uncoated magnifying lens (1) can have a reflectance of about 4% across the visible light spectrum, whereby a coated magnifying lens (1) may have a reflectance of less than about 0.5% across the visible light spectrum. As to particular embodiments of the latter, the magnifying lens (1) can be coated with an anti-reflective coating which may reduce reflectance of light having wavelengths of about 250 nanometers (nm) to about 2,000 nm. As but one illustrative example, the magnifying lens (1) can be coated with an anti -reflective coating which may reduce reflectance of light having wavelengths of about 350 nm to about 700 nm, whereby such a coating can reduce reflectance of visible light on each surface of the magnifying lens (1) to promote contrast in and vibrancy of the images.

[0114] To ensure optical quality, the magnifying lens (1) can have a surface quality of at least about 80-50 Scratch-Dig, whereby as to particular embodiments, the surface quality may be at least about 40-20 Scratch-Dig. In addition, the magnifying lens (1) can have a surface irregularity of less than about 31, whereby as to particular embodiments, the spherical surface irregularity may be about 1 / 2. Further, the magnifying lens (1) can have a wavefront error of <500 nm root-mean squared (RMS). Moreover, the magnifying lens (1) can have a Sag deviation of less than about 50 pm, whereby as to particular embodiments, the Sag deviation may be less than about 10 pm.

[0115] Now regarding shape, as to particular embodiments, the magnifying lens (1) configured as an optical lens can be an aspherical lens, which may be molded or polished, depending upon the diameter of the magnifying lens (1). For example, an aspherical magnifying lens (1) having a relatively smaller diameter (such as less than about 8 mm) can be molded, whereas an aspherical magnifying lens (1) having a relatively larger diameter (such as greater than about 8 mm) may be 1133P01T polished. As to particular embodiments, an aspherical magnifying lens (1) can be employed for applications in which it may be important to visualize the sclera and peripheral structures of the eye.

[0116] Concerning parameters, the aspherical magnifying lens (1) can have a focal length of about 15 mm to about 60 mm, whereby as to particular embodiments, the focal length may be about 20 mm to about 45 mm. The focal length of the magnifying lens (1) can be selected to ensure a safe working distance from the eye and effective magnification of the target structures.

[0117] Further concerning parameters, the aspherical magnifying lens (1) can have a numerical aperture of about 0.15 to about 0.70, whereby as to particular embodiments, the numerical aperture may be about 0.23 to about 0.40, which can ensure a safe working distance from the eye. Additionally, the aspherical magnifying lens (1) can have an f-number (or aperture ratio) of about 0.7 to about 3.15, whereby as to particular embodiments, the f-number may be about 0.8 to about 2. Also, the aspherical magnifying lens (1) can have a surface irregularity of not more than about 3

[0118] As but one illustrative example, the aspherical magnifying lens (1) can be made from CNC- polished N-BK7 with a refractive index of about 1.517, and may be coated with an anti -reflective coating to reduce reflectance of light having wavelengths of about 350 nm to about 700 nm. Additionally, the aspherical magnifying lens (1) can have a center thickness of about 4 mm, and a diameter of about 0.5 inches. At a wavelength of about 780 nanometers, the aspherical magnifying lens (1) can have a focal length of about 25 mm, an f-number of about 2, and a numerical aperture of about 0.23. Furthermore, the aspherical magnifying lens (1) can have a surface quality of about 40-20 Scratch-Dig, a Sag deviation of about + / - 5 pm, a surface irregularity of less than about 31, and a wavefront error of <500 nm RMS. The aspherical magnifying lens (1) can be disposed about 4 mm from the camera lens along the camera lens optical axis. Such a magnifying lens (1) can be optimized for focusing light incident on its aspherical side with minimal spherical aberrations.

[0119] Again regarding shape, as to particular embodiments, the magnifying lens (1) configured as an optical lens can be a spherical magnifying lens (1), which may be less costly to manufacture than an aspherical magnifying lens. Consequently, a spherical magnifying lens (1) can be used for applications in which cost may be constrained, such as in low-income and middle-income countries. 1133P01T

[0120] Concerning parameters, the spherical magnifying lens (1) can have a power of about X / 2 to about 21. In addition, the spherical magnifying lens (1) can have a numerical aperture of about 0.04 to about 0.5, whereby as to particular embodiments, the numerical aperture may be about 0.12 to about 0.25. Also, the spherical magnifying lens (1) can have an f-number of about 1 to about 5, whereby as to particular embodiments, the f-number may be about 1.5 to about 3. Moreover, the spherical magnifying lens (1) can have a focal length of about 15 mm to about 80 mm, whereby as to particular embodiments, the focal length may be about 20 mm to about 50 mm to ensure a safe working distance from the eye and effective magnification of the target structures. As to particular embodiments, for applications in which a larger (deeper) depth of field can be desired, the spherical magnifying lens (1) may have a focal length of about 40 mm to about 50 mm. Further, the spherical magnifying lens (1) can have a center thickness of about 2 mm to about 12 mm.

[0121] As to particular embodiments, the spherical magnifying lens (1) can be configured as a “best form” lens which includes two non-symmetric, spherical, convex surfaces that may be designed to minimize spherical aberrations while still using spherical surfaces to form the lens and maximize beam collimating and focusing performance.

[0122] Concerning parameters, the “best form” spherical magnifying lens (1) can have a focal length of about 20 mm to about 80 mm, whereby as to particular embodiments, the focal length may be about 30 mm to about 50 mm. Moreover, the “best form” spherical magnifying lens (1) can have a radius of curvature of the first surface of about 40 mm to about 172 mm and a radius of curvature of the second surface of about 10 mm to about 40 mm.

[0123] As but one illustrative example, the “best form” spherical magnifying lens (1) can be made from N-BK7 with a refractive index of about 1.517, and may be coated with an anti -reflective coating to reduce reflectance of light having wavelengths of about 350 nm to about 700 nm. Additionally, the “best form” spherical magnifying lens (1) can have a center thickness of about 4 mm, and a diameter of about 0.5 inches. Furthermore, the “best form” spherical magnifying lens (1) can have a power of about 31 / 2, a focal length of about 30 mm, a radius of curvature of the first surface of about 54.5 mm, a radius of curvature of the second surface of about 14.2 mm, an f-number of about 2, and a numerical aperture of about 0.25. Also, the “best form” spherical magnifying lens (1) can have a surface quality of about 20-10 Scratch-Dig and a surface irregularity of about 1 / 4. 1133P01T

[0124] As to particular embodiments, the spherical magnifying lens (1) can be configured as a plano-convex lens with near-best-form shape to reduce spherical aberrations.

[0125] Concerning parameters, the plano-convex spherical magnifying lens (1) can have a focal length of about 15 mm to about 80 mm, whereby as to particular embodiments, the focal length may be about 20 mm to about 50 mm. Moreover, the plano-convex spherical magnifying lens (1) can have a center thickness of about 2.5 mm to about 10 mm, and a radius of curvature of about

[0126] 7.5 mm to about 26 mm.

[0127] As but one illustrative example, the plano-convex spherical magnifying lens (1) can be made from N-BK7 with a refractive index of about 1.517, and may be coated with an anti -reflective coating to reduce reflectance of light having wavelengths of about 350 nm to about 700 nm. Additionally, the plano-convex spherical magnifying lens (1) can have a center thickness of about 3.2 mm, an edge thickness of about 1.8 mm, and a diameter of about 0.5 inches. Furthermore, the plano-convex spherical magnifying lens (1) can have a power of about 31 / 2 on its curved surface and about X / 2 on its flat surface, a focal length of about 30 mm, and a radius of curvature of about

[0128] 15.5 mm. Moreover, the plano-convex spherical magnifying lens (1) can have a numerical aperture of about 0.21 and an f-number of about 2.4. Also, the plano-convex spherical magnifying lens (1) can have a surface irregularity of less than about 1 / 4 and a surface quality of less than about 40-20 Scratch-Dig. The plano-convex spherical magnifying lens (1) can be disposed about 4 mm from the camera lens along the camera lens optical axis, whereby the resulting image resolution may be about 34 to about 40 line pairs per millimeter (Ip / mm).

[0129] As to particular embodiments, the spherical magnifying lens (1) can be configured as a biconvex spherical lens which includes two symmetric, spherical, convex surfaces.

[0130] Concerning parameters, the bi-convex spherical magnifying lens (1) can have a focal length of about 15 mm to about 80 mm, whereby as to particular embodiments, the focal length may be about 20 mm to about 50 mm. Moreover, the bi-convex spherical magnifying lens (1) can have a center thickness of about 2.6 mm to about 14.4 mm, and a radius of curvature of about 14.6 mm to about 76.6 mm.

[0131] As but one illustrative example, the bi-convex spherical magnifying lens (1) can be made from N-BK7 with a refractive index of about 1.517, and may be coated with an anti -reflective coating to reduce reflectance of light having wavelengths of about 350 nm to about 700 nm. 1133P01T

[0132] Moreover, the bi-convex spherical magnifying lens (1) can be disposed about 4 mm from the camera lens along the camera lens optical axis. Additionally, the bi-convex spherical magnifying lens (1) can have a center thickness of about 3.1 mm, an edge thickness of about 1.8 mm, a numerical aperture of about 0.21, and an f-number of about 2.5. Furthermore, the bi-convex spherical magnifying lens (1) can have a power of about 3A / 2, a focal length of about 30 mm, a radius of curvature of about 30.4 mm, a safe working distance of about 21 mm to about 22 mm, and a depth of field of about 6 mm to about 7 mm. Also, the bi-convex spherical magnifying lens (1) can have a surface quality of about 40-20 Scratch-Dig, and a surface irregularity of about 1 / 4. Figure 4A shows an image of an eye with an immature cataract captured with an embodiment of the eye imaging system including this lens configuration, whereby the resolution is about 34 Ip / mm.

[0133] Intraocular Lenses

[0134] As to particular embodiments, the magnifying lens (1) can be configured as an intraocular lens which includes a central optic that functions to focus light, whereby the optic may have a diameter which can be greater than the aperture diameter of the camera such that the intraocular lens fully covers the camera’s aperture. As an example, the intraocular lens can have a diameter of at least about 6 mm.

[0135] The intraocular lens can, but need not necessarily, further include peripheral haptics which extend from the optic and function to hold it in place in the eye. As to particular embodiments of the intraocular lens that include haptics, these peripheral structures can be used to mount the intraocular lens in front of the camera lens. Including the haptics, the intraocular lens can have a total length of about 10 mm to about 15 mm.

[0136] Upon coupling of the optical assembly (7) to the camera, the intraocular lens can dispose within about 7 mm of the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 7 mm from the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 6 mm from the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 5 mm from the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 4 mm from the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 3 mm from the camera lens. As to particular embodiments, the intraocular lens can dispose not greater than about 2 mm from the camera lens. As to particular embodiments, the intraocular 1133P01T lens can dispose not greater than about 1 mm from the camera lens. As but one illustrative example, the intraocular lens can dispose about 4 mm from the camera lens, which may maximize the depth of field of the intraocular lens and encompass the eye within the field of view.

[0137] The intraocular lens can be made from optical materials such as hydrophobic acrylic, hydrophilic acrylic, polymethyl methacrylate (PMMA), and the like, whereby the material may have at least 90% light transmission to ensure image clarity. As but one illustrative example, the intraocular lens can be made from hydrophobic acrylic, a durable material that may be less susceptible to surface deposits and glistening, both of which can negatively affect optical clarity.

[0138] The intraocular lens can have a power of about 5 diopters to about 20 diopters. As to particular embodiments, the intraocular lens can have a power of about 8 diopters to about 12 diopters. As but a first illustrative example, the intraocular lens can have a power of about 10 diopters, which may balance working distance, magnification, and depth of field, and can be effective for imaging the eye lens and the cornea. Such an intraocular lens can have a maximum resolution of about 34 Ip / mm and a depth of field of about 13 mm. As but a second illustrative example, the intraocular lens can have a power of about 12 diopters, which may provide greater magnification and thus, can be effective for imaging cornea anatomy and pathology in more detail, the latter including corneal abrasions, ulcers, and post-operative complications. Such an intraocular lens can have a maximum resolution of about 40 Ip / mm and a depth of field of about 8 mm. As but a third illustrative example, the intraocular lens can have a power of about 8 diopters, which may provide a larger (deeper) depth of field of about 24 mm with reduced magnification and a maximum resolution of about 22 Ip / mm, and can be effective for applications in which a high level a detail may not be needed, such as for screening purposes; further, such an intraocular lens can be effective for identifying the presence or absence of pathologies, such as a cataract, pterygium, conjunctivitis, large cornea opacities or ulcers, and the like.

[0139] Now regarding shape, the intraocular lens can be an aspherical lens or a spherical lens, depending upon the embodiment. As to particular embodiments, the intraocular lens can be an aspherical lens which may reduce optical aberrations, increase depth of field, and improve image contrast. As to particular embodiments, the intraocular lens can be an aspherical lens which introduces a minor negative spherical aberration of about -0.1 pm to about -0.03 pm; as but one illustrative example, the intraocular lens can introduce a -0.15 pm spherical aberration. 1133P01T

[0140] Again regarding shape, the intraocular lens can be a plano-convex intraocular lens or a biconvex intraocular lens, depending upon the embodiment.

[0141] The intraocular lens can be monofocal, multifocal, or extended depth of field (continuous focus), depending upon the embodiment. As to particular embodiments, an extended depth of field intraocular lens can provide a greater depth of field and correspondingly, may be suitable for imaging requiring the same.

[0142] As but one illustrative example, the intraocular lens can be aspheric with a spherical aberration of about -0.15 pm, bi-convex, monofocal, and made from hydrophobic acrylic with a refractive index of about 1.47 and light transmittance of greater than about 90%. Further, the intraocular lens can have a power of about 10 diopters, an optic diameter of about 6 mm, and an overall length of about 12.5 mm. Figure 4B shows an image of the same eye in Figure 4A captured with an embodiment of the eye imaging system including this lens configuration.

[0143] Supplementary Lenses

[0144] In addition to the magnifying lens (1), the optical assembly (7) can include one or more supplementary lenses which may be disposed along the camera lens optical axis proximate the magnifying lens (1). As to particular embodiments, the supplementary lens can be disposed a distance of up to about 40 mm from the magnifying lens (1); such a supplementary lens may have a focal length of about 50 mm to about 100 mm. As but one illustrative example, the supplementary lens can be disposed in front of the magnifying lens (1), which may shift the plane of focus anteriorly to allow precise focus on the cornea or other target structures.

[0145] As to particular embodiments, the supplementary lens can be an achromatic doublet lens or an achromatic triplet lens.

[0146] Light Sources

[0147] In addition to the magnifying lens (1), the optical assembly (7) includes an integrated light source (5) housed within the housing (2), whereby the light source (5) can provide light (such as visible light and / or non-visible light, for example infrared light or ultraviolet light) along a light path to illuminate target structures associated with ocular anatomy and pathology. Notably, whilst illumination can be necessary for observation and examination, due to high contrast surfaces (for 1133P01T example the bright white sclera and dark pupil and iris), capturing magnified images in which the target structures are effectively illuminated such that pathology (including early pathology with subtle presentation) may be detectable can be difficult. Variations in pupil size and pupil constriction can also complicate effective illumination of the target structures. Beneficially, the present eye imaging system effectively addresses these as well as other challenges.

[0148] The light source (5) housed within the housing (2) can be discrete or separate from a light source incorporated into the camera, such as a light source used to provide the camera’s flash. As to particular embodiments, the light source (5) can be a light-emitting diode (LED), such as a relatively small surface mount LED which may have a size of not greater than about 5 mm x about 5 mm or not greater than about 25 mm2. As to particular embodiments, the surface mount LED can have a size of (i) not greater than about 3.5 mm x about 3.5 mm, (ii) not greater than about 12.25 mm2, (iii) not greater than about 2.5 mm x about 2.5 mm, or (iv) not greater than about 6.25 mm2, whereby such a small size may minimize image obstruction by the LED’s reflection. As to particular embodiments, the LED can have a thermal resistance of not greater than about 30°C / Watt (W). As to particular embodiments, the LED can have a thermal resistance of not greater than about 12°C / W, which may facilitate longevity and suitable performance.

[0149] As to particular embodiments, a diffusion element can be disposed in front of the light source (5), such as diffusing film, acrylic, or glass. As to particular embodiments, a lens can be disposed in front of the light source (5) to focus its light. As to other particular embodiments, there can be no lens disposed in front of the light source (5); correspondingly, the light may travel from the light source (5) directly to the eye, with no lens therebetween.

[0150] Now referring primarily to Figures 2B and 3, regarding position, the light source (5) can be disposed about (or around or radially outward from) the perimeter (or circumference) of the magnifying lens (1) and correspondingly, about the magnifying lens optical axis (8). Following, the light source (5) does not coincide with the magnifying lens (1), and the light source (5) does not dispose along the magnifying lens optical axis (8); hence, when imaging, the light source (5) does not obstruct the optical pathway between the eye, the magnifying lens (1), the camera lens, and the sensor of the camera.

[0151] As the light source (5) can dispose about the perimeter of the magnifying lens (1), a light source axis which passes centrally through the light source (5) and is directed along the light path can dispose (i) radially outward from and (ii) generally parallel to the magnifying lens optical axis 1133P01T

[0152] (8). Consequently, the center of the light path can dispose (i) radially outward from and (ii) generally parallel to the magnifying lens optical axis (8).

[0153] Again regarding position, depending upon the embodiment, the light source (5) can be axially aligned with the magnifying lens (1) or axially offset from the magnifying lens (1), whereby as used herein, the term “axial” may mean along the magnifying lens optical axis (8). To further describe the latter, when the light source (5) is axially offset from the magnifying lens (1), the light source (5) disposed about the perimeter of the magnifying lens (1) does not lie within the plane passing through the perimeter of the magnifying lens (1); therefore, the light source (5) and the magnifying lens (1) are not coplanar. As to particular embodiments, the light source (5) can be axially offset from the magnifying lens (1) to position the light source (5) in front of the magnifying lens (1), meaning between the magnifying lens (1) and the housing distal end (4). As to other particular embodiments, the light source (5) can be axially offset from the magnifying lens (1) to position the light source (5) behind the magnifying lens (1), meaning between the magnifying lens (1) and the housing proximal end (3). Di stance- wise, the light source (5) can be axially offset from the magnifying lens (1) an axial distance of up to about 40 mm in front of or behind the magnifying lens (1). As but a first illustrative example, the light source (5) can be positioned an axial distance of about 10 mm in front of the magnifying lens (1), which may facilitate effective illumination of the eye for imaging. As but a second illustrative example, the light source (5) can be positioned an axial distance of about 5 mm in front of a magnifying lens (1) which disposes about 5 mm in front of the camera lens when imaging, whereby the magnifying lens (1) may have a diameter of about 0.5 inches and a focal length of about 30 mm.

[0154] White Light

[0155] As to particular embodiments, the light source (5) can provide white light (a “white light source,” for example an LED), such as diffuse white light, which may provide even illumination to facilitate visualization of gross anatomy, including the lids, eyelashes, conjunctiva, iris, and cornea. The white light can be warm to natural, with a color temperature of about 3,000 Kelvin (K) to about 6,000 K. As to particular embodiments, the white light can have a color temperature of about 3,500 K to about 4,200 K, which may facilitate accurate visualization of lens opacity and lens discoloration.

[0156] While a warmer white color temperature can provide increased image contrast and anterior segment illumination in dark-colored eyes, light-colored eyes may be more susceptible to 1133P01T discoloration under such warm lighting. For a balance therebetween, white light having a color temperature of about 3,500 K to about 4,200 K can facilitate effective visualization of dark-colored eyes while minimizing discoloration of light-colored eyes. Figure 5 A shows an image of a lightcolored eye captured with an embodiment of the eye imaging system including a white light source (5) having a color temperature of about 6,000 K, Figure 5B shows an image of the same eye in Figure 5A captured with an embodiment of the eye imaging system including a white light source (5) having a color temperature of about 4,000 K, Figure 5C shows an image of a dark-colored eye captured with an embodiment of the eye imaging system including a white light source (5) having a color temperature of about 6,000 K, and Figure 5D shows an image of the same eye in Figure 5C captured with an embodiment of the eye imaging system including a white light source (5) having a color temperature of about 4,000 K.

[0157] The white light can have a luminosity of about 35 lumens (Im) to about 120 Im, which may effectively illuminate the eye without causing overexposure or discomfort to the subject. Also, the white light can have a color rendering index of at least about 70, which may provide crisp and accurate coloration of lens pathology. Further, the white light source (5) (for example, an LED) can have a luminous efficiency of not less than about 60 Im / W. As to particular embodiments, the white light source (5) can have a luminous efficiency of not less than about 100 Im / W.

[0158] To effectively illuminate the anterior chamber and the eye lens, an illuminance of at least about 250,000 lux (lx) can be required to enter the anterior chamber; consequently, about 1.8 Im may be required to enter the anterior chamber.

[0159] The white light source (5) (for example, an LED) can have a viewing angle of about 70° to about 150°, which may provide even, diffuse illumination. As used herein, the term “viewing angle” can refer to the range of angles from which a light source (5) (such as an LED) may be viewed without significant reduction in brightness or color shift.

[0160] As to particular embodiments, the white light source (5) can have a viewing angle of about 90° to about 120°. As to particular embodiments, the white light source (5) can have a viewing angle of about 120° to about 130°, which may evenly illuminate the eye without diffusing light beyond the surface of the eye. Figure 5A shows an image of a light-colored eye captured with an embodiment of the eye imaging system including a white light source (5) having a viewing angle of about 60°, Figure 5B shows an image of the same eye in Figure 5A captured with an embodiment of the eye imaging system including a white light source (5) having a viewing angle 1133P01T of about 120°, Figure 5C shows an image of a dark-colored eye captured with an embodiment of the eye imaging system including a white light source (5) having a viewing angle of about 60°, and Figure 5D shows an image of the same eye in Figure 5C captured with an embodiment of the eye imaging system including a white light source (5) having a viewing angle of about 120°.

[0161] When imaging, the white light source (5) can be positioned to direct light into the pupil and illuminate the eye lens, which may facilitate anterior segment imaging for basic eye screening and triage as well as evaluation of eye lens status and visualization of cataracts. As to particular embodiments, when imaging, the white light source (5) can be positioned relative to the pupil of the eye. As to particular embodiments, when imaging, the white light source (5) can be positioned to dispose its light source axis proximate the margin of the pupil. As but one illustrative example, when imaging, the white light source (5) can be positioned to substantially align its light source axis with the margin of the pupil, which may maximize the amount of light entering the anterior chamber. When aligned, the reflection of the white light source (5) can appear on the margin of the pupil as a bright spot in the image, thus providing a visual indicator of proper positioning; correspondingly, the reflection may be employed for pupil centration, as detailed below. As but a second illustrative example, when imaging, the white light source (5) can be positioned to dispose its light source axis radially outward from the margin of the pupil, thereby disposing the reflection of the white light source (5) on the corneal surface; such positioning may optimize corneal reflection placement and minimize pupil obscuration. As to particular embodiments, when imaging, the white light source (5) can be positioned to dispose its light source axis radially outward from the margin of the pupil a distance of about 1 mm to about 5 mm. Of note, positioning of the white light source axis within the pupil, such as in the middle of the pupil, may obstruct visualization of cataracts.

[0162] Now regarding position, the white light source (5) can be disposed about the perimeter of the magnifying lens (1) and correspondingly, about the magnifying lens optical axis (8). As to particular embodiments, the white light source (5) can be positioned to dispose its light source axis radially outward from the magnifying lens optical axis (8) a radial distance of about 6 mm to about 25 mm, which may facilitate substantial alignment of its light source axis with the margin of the pupil when imaging.

[0163] While the white light source (5) can be disposed about the perimeter of the magnifying lens (1), it may also be disposed relatively close to the magnifying lens optical axis (8) and thus, relatively close to the optical pathway between the eye, the magnifying lens (1), the camera lens, 1133P01T and the sensor of the camera such that the area of illumination of the white light source (5) (which can be determined, at least in part, by its viewing angle) overlays the center of the eye to increase the amount of light entering the pupil and facilitate effective visualization of eye lens pathology, such as cataracts, with only diffuse illumination.

[0164] As to particular embodiments, the optical assembly (7) can include one white light source (5). As to other particular embodiments, the optical assembly can include a plurality of white light sources (5), such as two or more white light sources (5). Figures 6A through 6E show images of an eye with a cataract captured with an embodiment of the eye imaging system including (i) two white light sources (5) positioned in vertically-aligned spaced-apart relation (Figure 6A), (ii) two white light sources (5) positioned in horizontally-aligned spaced-apart relation (Figure 6B), (iii) two white light sources (5) positioned in vertically-aligned spaced-apart relation and two white light sources (5) positioned in horizontally-aligned spaced-apart relation (Figure 6C), (iv) one white light source (5) positioned on the temporal side of the eye (Figure 6D), and (v) one white light source (5) positioned on the nasal side of the eye (Figure 6E).

[0165] As but a first illustrative example of a plurality of white light sources (5), the optical assembly (7) can include two white light sources (5) (or one pair of white light sources (5)) disposed about the perimeter of the magnifying lens (1) in spaced-apart relation, such as in equidistant spaced-apart relation, opposed spaced-apart relation, diametrically-opposed spaced- apart relation, or the like. The two white light sources (5) can be positioned to dispose their corresponding light source axes radially outward from the magnifying lens optical axis (8) a radial distance of about 6 mm to about 25 mm; for two diametrically-opposed spaced-apart white light sources (5), the corresponding distance between their light source axes may be about 12 mm to about 50 mm. As to particular embodiments, the two white light sources (5) can be positioned to dispose their corresponding light source axes radially outward from the magnifying lens optical axis (8) a radial distance of about 9 mm to about 12 mm; for two diametrically-opposed spaced- apart white light sources (5), the corresponding distance between their light source axes may be about 18 mm to about 30 mm, which can facilitate even illumination of the eye. Moreover, such a distance can facilitate substantial alignment of the light source axes with the margin of the pupil when imaging. Figure 7A shows an image of an eye with a clear lens captured with an embodiment of the eye imaging system including two white light sources (5) located in horizontally-aligned spaced-apart relation and disposed about 18 mm apart which positions the reflections of the white light sources on the margin of the pupil, and Figure 7B shows an image of the same eye in Figure 1133P01T

[0166] 7A captured with an embodiment of the eye imaging system including two white light sources (5) located in horizontally-aligned spaced-apart relation and disposed about 25 mm apart.

[0167] Of note, with subjects having eyeballs that protrude more than average, the amount of light entering the anterior chamber can be reduced and result in dark regions in the center of the image; accordingly, when imaging, the positions of the white light sources (5) may need to be adjusted for such subjects.

[0168] As to particular embodiments, the two white light sources (5) can be disposed about the perimeter of the magnifying lens (1) (and when imaging, the camera lens) in vertically-aligned spaced-apart relation. For example, the two white light sources (5) can be circumferentially disposed in spaced-apart relation about the perimeter of the magnifying lens (1) about 180° apart, such as at about 0° and at about 180° relative to a vertical line passing through a center point between the two white light sources (5) from which each is equidistant. For reference, the vertical line can also pass through the center of the magnifying lens (1).

[0169] When imaging, vertically-aligned spaced-apart first and second white light sources (5) can be positioned relative to the pupil. As to particular embodiments, when imaging, the light source axes of the vertically-aligned spaced-apart first and second white light sources (5) can be positioned to substantially align with the margin of the pupil, which may maximize the amount of light entering the anterior chamber. Specifically, the first light source (5) can be positioned to substantially align its light source axis with the top of the margin of the pupil, and the second light source (5) may be positioned to substantially align its light source axis with the bottom of the margin of the pupil. As to particular embodiments, such a vertical white light source configuration can facilitate diagnostic accuracy of eye lens pathology and thus, may be suitable for grading eye lens pathology using diffuse illumination. As to particular embodiments, vertically-aligned spaced-apart first and second white light sources (5) can mimic a slit lamp which may facilitate visualization and classification of cataracts.

[0170] As an illustrative example, a diffuse white light source configuration can include a pair of vertically-aligned spaced-apart surface mount LEDs having a size of about 2.21 mm x about 2.21 mm, a viewing angle of about 120°, a color temperature of about 4,000 K, a luminous flux of about 75 Im at about 200 mA current, a luminous efficiency of about 166 Im / W, a color rendering index of about 90, a forward voltage of about 2.78 V, a maximum current of about 2 A, and a thermal resistance of about 4°C / W. The LEDs can be radially spaced-apart with a distance of about 20 mm 1133P01T between their light source axes. When imaging, the LEDs can be disposed about 10 mm in front of the camera lens and correspondingly, about 15 mm from the apex of the eye for even illumination thereof. Figures 8A through 8E show images of eyes captured with this embodiment of the eye imaging system having various anterior segment conditions including (i) a mature cataract, (ii) an immature cataract, (iii) a pseudophakic eye, (iv) a pterygium, and (v) infectious keratitis.

[0171] As to particular embodiments, the two white light sources (5) can be disposed about the perimeter of the magnifying lens (1) (and when imaging, the camera lens) in horizontally-aligned spaced-apart relation. For example, the two white light sources (5) can be circumferentially disposed in spaced-apart relation about the perimeter of the magnifying lens (1) about 180° apart, such as at about 90° and at about 270° relative to a vertical line passing through a center point between the two white light sources (5) from which each is equidistant. For reference, the vertical line can also pass through the center of the magnifying lens (1).

[0172] When imaging, horizontally-aligned spaced-apart first and second white light sources (5) can be positioned relative to the pupil. As to particular embodiments, when imaging, the light source axes of the horizontally-aligned spaced-apart first and second white light sources (5) can be positioned to substantially align with the margin of the pupil, which may maximize the amount of light entering the anterior chamber. Specifically, the first light source (5) can be positioned to substantially align its light source axis with the left of the margin of the pupil, and the second light source (5) may be positioned to substantially align its light source axis with the right of the margin of the pupil. As to particular embodiments, such a horizontal white light source configuration can (i) facilitate relatively easy positioning of the pupil in between the horizontally-aligned light sources (5) by looking to the left or right, (ii) be less susceptible to error if the subject moves their eye to the left or right, and (iii) provide more even illumination in the comers of the oblong eye.

[0173] As but a second illustrative example of a plurality of white light sources (5), the optical assembly (7) can include four white light sources (5) (or two pairs of white light sources (5)) disposed about the perimeter of the magnifying lens (1) in spaced-apart relation (such as in equidistant spaced-apart relation). As to particular embodiments, a first pair including two white light sources (5) can be disposed about the perimeter of the magnifying lens (1) in opposed spaced- apart relation (such as in diametrically-opposed spaced-apart relation), and a second pair including two white light sources (5) may be disposed about the perimeter of the magnifying lens (1) in opposed spaced-apart relation (such as in diametrically-opposed spaced-apart relation). As to 1133P01T particular embodiments, the first pair of two white light sources (5) can be disposed about the perimeter of the magnifying lens (1) in vertically-aligned spaced-apart relation as detailed above. Additionally, the second pair of two white light sources (5) can be disposed about the perimeter of the magnifying lens (1) in horizontally-aligned spaced-apart relation as detailed above. Correspondingly, the four white light sources (5) can be circumferentially disposed in spaced-apart relation about the perimeter of the magnifying lens (1) about 90° apart, such as at about 0°, at about 90°, at about 180°, and at about 270° relative to a vertical line passing through a center point between the four white light sources (5) from which each is equidistant. For reference, the vertical line can also pass through the center of the magnifying lens (1).

[0174] When imaging, the vertically-aligned spaced-apart white light sources (5) and the horizontally-aligned spaced-apart white light sources (5) can be positioned relative to the pupil as detailed above. Hence, the vertically-aligned spaced-apart white light sources (5) can be positioned to substantially align their light source axes with the top and bottom of the margin of the pupil, and the horizontally-aligned spaced-apart white light sources (5) may be positioned to substantially align their light source axes with the left and right of the margin of the pupil.

[0175] As but a third illustrative example of a plurality of white light sources (5), the optical assembly (7) can include more than four light sources (5) disposed about the perimeter of the magnifying lens (1) in spaced-apart relation (such as in equidistant spaced-apart relation).

[0176] A significant determinant of the amount of white light entering the anterior chamber can be the axial distance between the white light source (5) and the eye of the subject when imaging. The white light source (5) can be disposed an axial distance of about 10 mm to about 55 mm from the apex of the eye when imaging. As to particular embodiments, the white light source (5) (such as an LED having a viewing angle of about 120°) can be disposed an axial distance of about 11 mm to about 18 mm from the apex of the eye when imaging, which may achieve at least 250,000 lx entering the anterior chamber for illumination. As to particular embodiments, the white light source (5) (such as an LED having a viewing angle of about 120°) can be disposed an axial distance of about 13 mm to about 17 mm from the apex of the eye when imaging, which may maximize the amount of light entering the anterior chamber for illumination. Figure 9A shows an image of an eye with a nuclear sclerosis grade II cataract captured with an embodiment of the eye imaging system including two white light sources (5) positioned in vertically-aligned spaced-apart relation and disposed about 12 mm from the eye, and Figure 9B shows an image of the same eye in Figure 1133P01T

[0177] 9A captured with an embodiment of the eye imaging system including two white light sources (5) positioned in vertically-aligned spaced-apart relation and disposed about 15 mm from the eye.

[0178] The axial distance between the white light source (5) and the eye when imaging can be determined, at least in part, by the axial distance between the white light source (5) and the subject interface distal end (9) of the subject interface (6) which may facilitate fixing the axial distance between the white light source (5) and the eye, as detailed below.

[0179] Blue Light

[0180] As to particular embodiments, the light source (5) can provide blue light (a “blue light source,” for example an LED), such as cobalt blue light having a wavelength of about 430 nm to about 470 nm with peak fluorescence at about 450 nm. Such blue light can facilitate assessment of the health of the cornea and visualization of corneal pathology (such as abrasions, infiltrates, infections, or dry eye) upon fluorescein staining of the eye.

[0181] The blue light can have a brightness of about 10 Im to about 120 Im. As to particular embodiments, the blue light can have a brightness of about 20 Im to about 45 Im, which may reduce over-exposure of the fluorescein stain.

[0182] The blue light source (5) (for example, an LED) can have a viewing angle of not less than about 90° to provide even illumination across the cornea. In addition, the blue light source (5) can be located to dispose its light source axis radially outward from the magnifying lens optical axis (8) a radial distance of about 8 mm to about 25 mm. For two diametrically-opposed spaced-apart blue light sources (5), the corresponding distance between their light source axes can be about 16 mm to about 50 mm. As to particular embodiments, the distance between two diametrically- opposed spaced-apart blue light sources (5) can be about 16 mm to about 28 mm. When imaging, the blue light source (5) can be disposed an axial distance of about 10 mm to about 30 mm from the apex of the eye.

[0183] As an illustrative example, a blue light source configuration can include a pair of horizontally-aligned spaced-apart surface mount LEDs having a size of about 3.5 mm x about 2.8 mm, a wavelength of about 455 nm, a luminous flux of about 31 Im at about 200 mA current, a forward voltage of about 3 V, a maximum current of about 250 mA, and a thermal resistance of about 12°C / W. The LEDs can be radially spaced-apart with a distance of about 20 mm between 1133P01T their light source axes. When imaging, the LEDs can be disposed about 10 mm in front of the camera lens. Figure 10 shows an image of an eye with infectious keratitis captured with this embodiment of the eye imaging system including blue light, whereby the eye is stained with fluorescein stain.

[0184] As to particular embodiments, blue light can be provided by a cobalt blue filter which may be disposed, such as adjustably disposed via flipping or sliding, in front of a white light source (5).

[0185] As to particular embodiments, a yellow filter which can reduce transmittance of light with a wavelength of less than about 510 nm may be removably disposed in front of the camera lens to reduce overexposure and enhance the contrast between the fluorescein stain and the surrounding blue light.

[0186] White and Blue Light

[0187] As to particular embodiments, the optical assembly (7) can include both at least one white light source (5) and at least one blue light source (5) disposed about the perimeter of the magnifying lens (1) in spaced-apart relation. Now referring primarily to Figure 11 A, as an illustrative example, the optical assembly (7) can include one white light source (5) and one blue light source (5) disposed about the perimeter of the magnifying lens (1) in diametrically-opposed spaced-apart relation and substantially radially equidistant from the magnifying lens optical axis (8). Now referring primarily to Figures 1 IB and 11C, as illustrative examples, the optical assembly (7) can include two white light sources (5) and two blue light sources (5) disposed about the perimeter of the magnifying lens (1) in equidistant spaced-apart relation and substantially radially equidistant from the magnifying lens optical axis (8), whereby the two white light sources (5) may dispose in diametrically-opposed spaced-apart relation (such as in vertically-aligned spaced apart relation as shown in Figure 1 IB or in horizontally-aligned spaced-apart relation as shown in Figure 11C) and the two blue light sources (5) can dispose in diametrically-opposed spaced-apart relation (such as in horizontally-aligned spaced apart relation as shown in Figure 1 IB or in vertically- aligned spaced-apart relation as shown in Figure 11C). Now referring primarily to Figure 1 ID, as an illustrative example, the optical assembly (7) can include four white light sources (5) and four blue light sources (5) disposed about the perimeter of the magnifying lens (1) in equidistant spaced- apart relation and substantially radially equidistant from the magnifying lens optical axis (8), whereby two of the white light sources (5) may in dispose vertically-aligned spaced apart relation and two of the white light sources (5) can dispose in horizontally-aligned spaced-apart relation, 1133P01T and the four blue light sources (5) may dispose equidistantly between the vertically-aligned and horizontally-aligned four white light sources (5). Now referring primarily to Figures 1 IE and 1 IF, as illustrative examples, the optical assembly (7) can include two white light sources (5) and two blue light sources (5) disposed about the perimeter of the magnifying lens (1), whereby the two white light sources (5) may dispose in diametrically-opposed spaced-apart relation (such as in vertically-aligned spaced apart relation as shown in Figure 1 IE or in horizontally-aligned spaced- apart relation as shown in Figure 1 IF) and the two blue light sources (5) can dispose in diametrically-opposed spaced-apart relation (such as in vertically-aligned spaced apart relation as shown in Figure 1 IE or in horizontally-aligned spaced-apart relation as shown in Figure 1 IF), and whereby the two white light sources (5) may be radially offset from the two blue light sources (5) (for example, the two white light sources (5) can dispose radially closer to the magnifying lens optical axis (8) and the two blue light sources (5) may dispose radially farther from the magnifying lens optical axis (8)). Now referring primarily to Figure 11G, as an illustrative example, the optical assembly (7) can include four white light sources (5) and four blue light sources (5) disposed about the perimeter of the magnifying lens (1), whereby two of the white light sources (5) may in dispose in vertically-aligned spaced apart relation and two of the white light sources (5) can dispose in horizontally-aligned spaced-apart relation, and two of the blue light sources (5) may in dispose in vertically-aligned spaced apart relation and two of the blue light sources (5) can dispose in horizontally-aligned spaced-apart relation, and whereby the four white light sources (5) may be radially offset from the four blue light sources (5) (for example, the four white light sources (5) can dispose radially closer to the magnifying lens optical axis (8) and the four blue light sources (5) may dispose radially farther from the magnifying lens optical axis (8)). Now referring primarily to Figure 11H, as an illustrative example, the optical assembly (7) can include eight white light sources (5) and eight blue light sources (5) disposed about the perimeter of the magnifying lens (1), whereby two of the white light sources (5) may in dispose vertically-aligned spaced apart relation, two of the white light sources (5) can dispose in horizontally-aligned spaced-apart relation, and four of the white light sources (5) may dispose equidistantly between the vertically- aligned and horizontally-aligned four white light sources (5). Additionally, two of the blue light sources (5) can in dispose vertically-aligned spaced-apart relation, two of the blue light sources (5) may dispose in horizontally-aligned spaced-apart relation, and four of the blue light sources (5) can dispose equidistantly between the vertically-aligned and horizontally-aligned four blue light sources (5). The eight white light sources (5) can be radially offset from the eight blue light sources (5) (for example, the eight white light sources (5) may dispose radially closer to the magnifying lens optical axis (8) and the eight blue light sources (5) can dispose radially farther from the magnifying lens optical axis (8)). Now referring primarily to Figure 1 II, as an illustrative 1133P01T example, the optical assembly (7) can include two white light sources (5) and two blue light sources (5) disposed about the perimeter of the magnifying lens (1). A first white light source (5) and a first blue light source (5) can dispose in vertically-aligned spaced-apart relation to provide a first pair of light sources, and a second white light source (5) and a second blue light source (5) can dispose in vertically-aligned spaced-apart relation to provide a second pair of light sources, whereby the first and second pairs of light sources may dispose in horizontally-aligned spaced- apart relation. The second pair of light sources can be inverted relative to the first pair of light sources such that one pair has its white light source (5) on the top, and the other pair has its white light source (5) on the bottom. The first and second pairs of light sources can dispose along a central horizontal axis.

[0188] As to particular embodiments, the optical assembly (7) can include one or more multicolored light sources (5), such as RGB-W LEDs, which may provide both white and blue light, depending upon the illumination mode. Now referring primarily to Figure 11 J, as an illustrative example, the optical assembly (7) can include two multicolored light sources (5) disposed about the perimeter of the magnifying lens (1) in diametrically-opposed spaced-apart relation and substantially radially equidistant from the magnifying lens optical axis (8). Now referring primarily to Figure 1 IK, as an illustrative example, the optical assembly (7) can include four multicolored light sources (4) disposed about the perimeter of the magnifying lens (1) in equidistant spaced-apart relation and substantially radially equidistant from the magnifying lens optical axis (8), whereby two of the multicolored light sources (5) may dispose in vertically- aligned spaced apart relation and two of the multicolored light sources (5) can dispose in horizontally-aligned spaced-apart relation.

[0189] As to particular embodiments, the optical assembly (7) can include one or more light sources (5) (for example, LEDs) which provide light having a color other than white or blue. As illustrative examples, the optical assembly (7) can include a light source (5) which provides (i) deep red light having a wavelength of about 650 nm to about 670 nm, (ii) red light having a wavelength of about 620 nm to about 645 nm, (iii) yellow light having a wavelength of about 570 nm to about 590 nm, or (iv) green light having a wavelength of about 520 nm to about 550 nm.

[0190] Power Source

[0191] The above light sources (5) can be powered by a power source which may be integrated with the optical assembly (7) or discrete from the optical assembly (7), depending upon the 1133P01T embodiment. Regarding the former, as to particular embodiments, the light sources (5) can be powered by battery, such as a rechargeable lithium ion battery, integrated with the optical assembly (7) and for example, housed within the housing (2).

[0192] As to other particular embodiments, the light sources (5) can be powered by a smartphone including the portable camera which may be discrete from the optical assembly (7), such as via the smartphone’s On The Go (OTG) adapter which can produce about 5 V and about 500 mA current. The OTG adapter can allow a USB connection, which may facilitate portability and usability in settings where a wired power source is not available. As to embodiments powered by a smartphone including the portable camera , the light sources (5) can have a forward voltage of not greater than about 4.5 V and a minimum current of not greater than about 200 mA to support the OTG power functionality.

[0193] Light Source Mount

[0194] Now referring primarily to Figure 12A through 12C, the light source (5) can be mounted on a printed circuit board (PCB) (10) housed within the housing (2). The PCB (10) can include a central aperture (11) aligned with the magnifying lens optical axis (8) and extending beyond the perimeter of the magnifying lens (1) such that the PCB (10) does not obstruct the optical pathway between the eye, the magnifying lens (1), the camera lens, and the sensor of the camera when imaging. Correspondingly, a light source (5) mounted on the PCB (10) can dispose about the perimeter of the magnifying lens (1). The PCB (10) can be powered via a power source integrated with the optical assembly (7) (for example a USB port (12) as shown in Figure 12C) or discrete from the optical assembly (7), as detailed above.

[0195] The PCB (10) can be located an axial distance of up to about 40 mm in front of or behind the magnifying lens (1). As but one illustrative example, the PCB (10) can be located an axial distance of about 10 mm in front of the magnifying lens (1).

[0196] Housing

[0197] The optical assembly (7) includes a housing (2) which houses the magnifying lens (1) and the light source (5). The housing (2) can be configured to removably couple to a portable camera having a camera lens with a camera lens optical axis, whereby upon coupling, the magnifying lens 1133P01T

[0198] (1) disposes along the camera lens optical axis. As an illustrative example, the housing (2) can removably couple to the rear of a mobile computing device which includes the camera.

[0199] Now referring primarily to Figures 2A through 3, the housing (2) includes a housing proximal end (3) and an opposing housing distal end (4), whereby a housing sidewall (13) extends therebetween and defines a housing interior space in which the magnifying lens (1) and the light source (5) can be disposed. Also, the optical pathway between the eye, the magnifying lens (1), the camera lens, and the sensor of the camera passes through the housing interior space.

[0200] The housing (2) can have a variety of geometries which may effectively house the magnifying lens (1) and the light source (5). As but one illustrative example, the housing (2) can have a generally tubular or annular shape, such as but not limited to a generally cylindrical shape with a generally circular cross-section. Further, the housing (2) can have a variety of dimensions which may effectively house the magnifying lens (1) and the light source (5) and properly position the eye for imaging. As to particular embodiments of a generally cylindrical housing (2), the length of the housing (2) between the housing proximal and distal ends (3)(4) (which can be dictated, at least in part, by the working distance of the magnifying lens (1)) may be about 8 mm to about 25 mm. As but one illustrative example of a generally cylindrical housing (2), its length can be about 12 mm and its diameter can be about 48 mm.

[0201] The housing (2), which can protect the magnifying lens (1) and the light source (5) from impact during storage, transportation, and use as well as from environmental factors, may be made of a suitable material therefor, such as various plastics, resins, metals, and the like. The exact choice of material to be used can depend on a variety of factors, such as size, weight, and the like.

[0202] Subject Interface

[0203] The optical assembly (7) includes a subject interface (6) coupled to the housing (2) (such as via mating engagement, mechanical fastening, adhesive fastening, or the like) proximate the housing distal end (4), whereby the subject interface (6) can include a subject interface distal end (9) configured to comfortably contact and sealingly engage with a subject’s face around their eye.

[0204] Now referring primarily to Figures 2A through 3, the subject interface (6) includes a subject interface proximal end (14) and the opposing subject interface distal end (9), whereby a subject interface sidewall (15) extends therebetween and defines a subject interface interior space 1133P01T which communicates with the housing interior space. Additionally, the optical pathway between the eye, the magnifying lens (1), the camera lens, and the sensor of the camera passes through the subject interface interior space.

[0205] The subject interface (6) can have a variety of geometries which may effectively encompass the orbital cavity and sealingly engage with a subject’s face. As but one illustrative example, the subject interface (6) can have a generally tubular or annular shape, such as but not limited to a generally cylindrical shape with a generally circular cross-section.

[0206] Upon engagement of the subject interface (6) with the subject’s face, the subject interface (6) and the housing (2) can prevent ambient light from entering the subject interface interior space (such as via the subj ect interface distal end (9)) and the housing interior space and correspondingly, the subject interface (6) and the housing (2) may provide a relatively dark standardized environment to facilitate eye imaging. Further, upon engagement, the subject interface (6) and the housing (2) can be stabilized against the subject’s face, which may minimize motion and associated motion artifacts when imaging. Moreover, upon engagement of the subject interface (6) with a subject’s face, the subject interface (6) and the housing (2) can fix and standardize the distance between the subject’s eye and the camera lens to properly position the focal plane of the camera lens on the lens-iris plane of the eye.

[0207] The subject interface (6) can be made from a material suitable for conforming to the subject’s face and comfortably engaging therewith, including silicone, rubber, plastic, soft plastic, foam, and the like. As to particular embodiments made from silicone or rubber (such as medical grade silicone or rubber), the material can have a Shore hardness of between about 10A to about 60 A, which may be compliant and comfortable against the subject’s face.

[0208] As to particular embodiments, the subject interface (6) can be made from a resiliently compressible material which may be forcibly compressed lengthwise upon engagement with the subject’s face to shorten the length of the subject interface (6) and thereby lessen the standardized distance between the subject’s eye and the camera lens, whereby such shortening can allow for accommodation of anatomical differences between subjects (such as differences in the depth of the orbital cavity) and may allow for location of the camera lens closer to the subject’s eye for effective imaging. As but one illustrative example, the subject interface (6) can be compressible lengthwise by up to about 3 mm, thereby permitting shortening of its length by up to about 3 mm. 1133P01T

[0209] The subject interface (6) can have a variety of dimensions which may properly position the eye for imaging. As to particular embodiments of a generally cylindrical subject interface (6), the length of the subject interface (6) between the subject interface proximal and distal ends (14)(9) (which can be dictated, at least in part, by the working distance of the magnifying lens (1)) may be about 8 mm to about 35 mm. In addition, the diameter of the subject interface (6) can be about 32 mm to about 60 mm, whereby such a range may be sufficient to accommodate both pediatric and adult subjects. As but one illustrative example of a generally cylindrical subject interface (6), its length can be about 12.5 mm which may position the magnifying lens (1) about 25 mm ± 5 mm from the eye when imaging, and its diameter can be about 48 mm. As to particular embodiments, the subject interface (6) can flare toward the subject interface distal end (9), such as at an angle of about 60°. As to particular embodiments, the subject interface (6) can be configured to removably couple to the housing (2), thereby permitting attachment of variably-sized subject interfaces (6) to allow for accommodation of anatomical differences between subjects.

[0210] The subject interface (6) can have a monocular configuration (thus engaging with a subject’s face around only one eye) or a binocular configuration (thus engaging with a subject’s face around both eyes), depending upon the embodiment.

[0211] As to particular embodiments, a speculum or similar tool which can hold the eye open for imaging may couple to the subject interface (6). As but one illustrative example, the subject interface (6) can include one or more ports through which the speculum may be passed for holding the eye open. As but a second illustrative example, the subject interface (6) can include a speculum integrated therewith, such as one or more adjustable pads that may contact the upper eyelid, the lower eyelid, or both, whereby the pads can be moved apart to hold the eye open once in contact with the eyelids.

[0212] Portable Camera

[0213] The optical assembly (7) can be configured to removably couple to a portable camera having a camera lens to provide the eye imaging system. The portable camera can be coupled to, incorporated into, or integrated with a mobile computing device, such as but not limited to a mobile phone, a smartphone, a tablet, alaptop, a personal computer, a personal digital assistant, a webcam, a digital camera, a video camera, a camera module, a Digital Single-Lens Reflex (DSLR) camera, or other portable devices including a camera and a computer device (such as a Raspberry Pi, Arduino, etc.). 1133P01T

[0214] In addition to the camera having a camera lens, the mobile computing device can include a processor capable of controlling operation of the mobile computing device, a memory capable of storing one or more applications, apps, or computer programs executable by the processor, a wireless or wired communication component which allows the mobile computing device to communicate with external devices via a communication network, an input component which may be manipulated by a user and enables the mobile computing device to receive input of various types, and an output component which can display information on a display screen for a user to view.

[0215] As to particular embodiments, the mobile computing device can have a front-facing display and a rear-facing camera lens.

[0216] The optical assembly (7) can be used with a variety of different mobile computing devices having different dimensions and different camera locations. As to particular embodiments, the optical assembly (7) can be available in numerous specific configurations whereby each may be customized for a specific mobile computing device. As but one illustrative example, the optical assembly (7) can be incorporated into a specific case for a specific mobile computing device, such as a case for an Apple iPhone, Samsung Galaxy, Google Pixel, etc. Upon situating the mobile computing device in its case, the magnifying lens (1) of the optical assembly (7) can dispose along the camera lens optical axis.

[0217] As to other particular embodiments, the optical assembly (7) can be adjustable, such as to make it substantially “universal” to accommodate numerous different mobile computing device configurations, such as via use of a variety of different engagement mechanisms, for example clamps, adhesives, magnets, clips, bands, straps, etc.

[0218] As but one illustrative example, the optical assembly (7) can employ a clamp which may be fastened to the mobile computing device, such as proximate one or more sides of the mobile computing device, and secured thereto, such as via a linear spring, thumbscrew, trigger, or the like.

[0219] As but a second illustrative example, the optical assembly (7) can employ magnetism. As to particular embodiments, a removable metallic ring can be coupled, such as via a removable adhesive, to the rear of the of the mobile computing device around the camera lens, whereby an alignment guide may facilitate correct positioning. The optical assembly (7) can include one or 1133P01T more cooperating magnets which may secure it to the metallic ring and thus, the mobile computing device.

[0220] As but a third illustrative example, a removable first mateable component can be coupled, such as via a removable adhesive, to the mobile computing device around the camera lens, and a removable second mateable component may be coupled to the optical assembly, whereby the first and second components can mateably engage via a twist-and-lock mechanism. As to particular embodiments, the first mateable component can include a plurality of protrusions (such as pegs), and the second mateable component may include a plurality of corresponding recesses (such as channels), whereby following receipt of the pegs within the channels, the first and second mateable components can be lockingly engaged via twisting.

[0221] As to particular embodiments, the optical assembly (7) can include a mechanism which allows translation in one or two directions, such as a track along which the magnifying lens (1) may be adjustable to dispose it along the camera lens optical axis.

[0222] As to particular embodiments, the optical assembly (7) can be configured for use with ophthalmic screening equipment, including optical coherence tomography equipment, conventional slit lamps, existing imaging equipment, or other equipment in order to capture anterior segment images for direct review, telemedicine-based review, or artificial intelligencebased review. As to other particular embodiments, the optical assembly (7) can be configured as a standalone, tabletop device.

[0223] As to particular embodiments, software can be employed to ensure concentric alignment of the magnifying lens (1) with the camera lens, such as via measuring the amount of field of view that is obscured by the optical assembly (7) and providing feedback to the user regarding adjustment for proper alignment.

[0224] Pupil Centration

[0225] The optical assembly (7) can include a pupil centration system which may facilitate locating the eye and the pupil in the center of the image when imaging to direct light into the pupil, maximize the amount of light entering the anterior chamber, and optimize illumination of the target structures. 1133P01T

[0226] The pupil centration system can utilize the reflections of two or more light sources (5), such as white light sources (5), to provide feedback to the user and thus, facilitate centering the pupil in the image. As detailed above, the white light sources (5) can be positioned to substantially align their light source axes with the margin of the pupil; when aligned, the reflections of the light sources (5) may appear on the margin of the pupil as bright spots in the image, thereby providing a visual indicator of proper alignment for pupil centration.

[0227] As but one illustrative example, the pupil centration system can employ the reflections of horizontally-aligned spaced-apart first and second white light sources (5) as visual indicators of proper alignment for pupil centration. Following engagement of the subject interface (6) with the subject’s face, to achieve pupil centration, the eye imaging system can be movably adjusted until the reflection of the first light source (5) disposes substantially on the left of the margin of the pupil and the reflection of the second light source (5) disposes substantially on the right of the margin of the pupil, thereby locating the reflections symmetrically about the center of the pupil.

[0228] As but a second illustrative example, the pupil centration system can employ the reflections of vertically-aligned spaced-apart first and second white light sources (5) as visual indicators of proper alignment for pupil centration. Following engagement of the subject interface (6) with the subject’s face, to achieve pupil centration, the eye imaging system can be movably adjusted until the reflection of the first light source (5) disposes substantially on the top of the margin of the pupil and the reflection of the second light source (5) disposes substantially on the bottom of the margin of the pupil, thereby locating the reflections symmetrically about the center of the pupil.

[0229] The reflections of the light sources (5) can be used in conjunction with image processing or artificial intelligence approaches to provide feedback about pupil alignment and centration to the user. Image processing techniques such as thresholding, edge detection, and morphological operations can be used to detect and isolate the reflections on the margin of the pupil. Once isolated, geometric properties, such as the centroid or symmetry, can be calculated to determine the center of the reflections. A computer vision algorithm such as the Circular Hough Transform (CHT) can be utilized to identify the circular pupil and the center of the pupil, and the position of the reflections in relation thereto may be used for proper alignment for pupil centration. Machine learning algorithms (such as convolutional neural networks (CNNs)) can be trained on large datasets of annotated images to recognize the characteristic positions of reflections which are indicative of proper alignment for pupil centration. By learning from examples, these algorithms can accurately classify images as having centered pupils or off-center pupils based on the positions 1133P01T of the reflections. Feature matching algorithms, such as Scale-Invariant Feature Transform (SIFT) or Speeded Up Robust Features (SURF), can be used to identify and match key points or features in the image, including the positions of the reflections. By comparing the matched points or features to a reference template, the algorithm can determine the degree of pupil alignment and centration.

[0230] The reflections of the light sources (5) can also be helpful for artificial intelligence-based image segmentation and diagnosis, as the reflections may provide a consistent landmark for image standardization which can facilitate reliable detection of the boundaries of the pupil and iris. Additionally, the reflections can serve as initial seeds or markers for segmentation algorithms; upon identifying the positions of the reflections, preprocessing algorithms may initialize segmentation processes and guide subsequent segmentation steps towards accurately identifying key structures.

[0231] As to particular embodiments, the pupil centration system can include a fixation target coupled to the optical assembly (7) which provides a visual focus point for the subject and promotes a central gaze direction to facilitate proper alignment and pupil centration. As but one illustrative example, the fixation target can be a light source (such as an LED), a brightly colored or reflective surface, an image, or the like. As to particular embodiments, the fixation target can be located within the subject interface (6) or the housing (2) (such as proximate the camera lens) in view of the eye being imaged and may be configured as a single fixation point for focusing on, multiple fixation points for focusing between, or an annular element for focusing within. As to other particular embodiments, the fixation target can be located outside of the subject interface (6) in view of the eye not being imaged. As the eyes are typically aligned and track together, the eye being imaged tends to track in tandem with the eye focused on the fixation target located outside of the subject interface (6) for proper alignment and pupil centration

[0232] Now referring primarily to Figure 13, as to particular embodiments, the pupil centration system can include an aperture (16), such as a pinhole, coupled to the optical assembly (7), whereby the pinhole (16) may provide a visual focus point for the subject and promote a central gaze direction to facilitate proper alignment and pupil centration. The pinhole (16) can be located outside of the subject interface in view of the eye not being imaged such that when this eye looks through the pinhole (16), it is looking straight ahead. As the eyes are typically aligned and track together, the eye being imaged tends to track in tandem with the eye looking through the pinhole (16) for proper alignment and pupil centration. 1133P01T

[0233] The pinhole (16) can be incorporated into a conical-shaped occluder (17), whereby the cone (or funnel) (18) may function to fully encompass and occlude vision to draw the gaze of the eye to a central point provided by the pinhole (16). The cone (18) can also function to increase the distance between the eye and the pinhole (16), which may mitigate variations in interpupillary distance and correspondingly facilitate effective pupil alignment. The cone (18) can have a height of at least about 15 mm and a base with a diameter of at least about 25 mm. The diameter of the pinhole (16) can be about 3 mm to about 10 mm and the distance between the center of the subject interface (6) and the center of the pinhole (16) can be about 48 mm to about 74 mm. As but one illustrative example, the diameter of the pinhole (16) can be about 5 mm and the distance between the center of the subject interface (6) and the center of the pinhole (16) can be about 56 mm, which may be based on the average interpupillary distance.

[0234] Software

[0235] The handheld eye imaging system can be used with dedicated software, such as an application for the mobile computing device that may control camera focus, white balance (which can be optimized between about 2,700 K to about 6,000 K), exposure (which can be optimized between about -0.5 to about +0.2), magnification, and various other parameters.

[0236] As to particular embodiments, the software can guide the image capture process in real time to facilitate acquisition of optimal images. During the image capture process, the software can provide real-time feedback (such as on the display of the mobile computing device), whereby such feedback may include visual indicia or cues (characters, colors, shapes, symbols, etc.) which overlay the live camera feed to inform the user about the quality of the image and specifically, about eye openness, eye centration, pupil centration, illumination of target structures, and focus of target structures. If suboptimal, the user can be provided with guidance for optimization.

[0237] The software can prompt the user to manually capture an optimized image, or image capture may be automated when an optimal image is achieved. If the captured image fails to meet quality standards, the software can prompt the user to recapture the image.

[0238] As to particular embodiments, during the image capture process, the software can facilitate eye centration and pupil centration with alignment guides, such as by displaying shaped outlines over the live camera feed as shown in Figure 14. For pupil centration, a circular outline can be 1133P01T displayed which may be the approximate size of the pupil when the correct focus plane is achieved; following, the user can centrally align the pupil within the circle for optimal imaging.

[0239] As shown in Figure 15, image segmentation can be used to computationally determine and subsequently inform the user when the pupil is properly centered and / or provide direction for proper centering. Cue-wise, arrows can be displayed on the live camera feed to prompt the user to move the camera in a corresponding direction for proper pupil centration; once centered, the circle may change color (such as from red to green) to prompt the user to capture the optimized image. As to particular embodiments, to aid with pupil centration, the software can provide alignment grids which may guide the user for proper positioning of the eye. As to particular embodiments, the software can be used in conjunction with the reflections of the light sources (5) to facilitate pupil centration as detailed above. As to particular embodiments, in addition to a centered pupil, the software can determine when the eye is fully open and looking straight ahead to facilitate optimal imaging.

[0240] As to particular embodiments, during the image capture process, the software can facilitate focusing on target structures, such as by employing one or more algorithms to determine in real time which regions of the image are in-focus, for example by calculating the Laplacian variance of the image or using gradient based methods. As shown in Figure 16, in-focus regions of the image can be identified and indicated on the live camera feed, for example via a visual cue which may provide a focus guide. As to particular embodiments, the sharpness of regions within the image can be quantified, and a sharpness score and / or focus map may be displayed or overlaid as a guide on the live camera feed to inform the user of the sharply focused regions. Image segmentation can be used to computationally determine and subsequently inform the user which target structures are in-focus. To achieve the correct focus plane, the user can be prompted, such as with arrows, to move the camera lens closer to or farther from the subject’s eye. Figure 17 shows an exemplary user interface which combines alignment guides and focus guides, whereby in this image, the eye is aligned, the pupil is not centered, and the eyelashes are in focus. Figure 18 shows an exemplary user interface which combines alignment guides and focus guides, whereby in this image, the eye is aligned, the pupil is centered, and the iris plane is in focus; correspondingly, the image can be captured.

[0241] As to particular embodiments, during the image capture process, the software can employ selective focus which may be combined with computer vision or image processing techniques to detect anatomical landmarks and / or target structures and selectively focus on those regions. For 1133P01T example, image processing techniques such as Canny Edge Detection or Circular Hough Transform (CHT) can be used to detect the limbus and the pupil. Once the anatomical landmarks and / or target structures are detected, their coordinates can be extracted and analyzed to determine the optimal focus point for image capture, such as via averaging or weighting the coordinates to calculate a representative focal point which encompasses all detected target structures. Following, the software can dynamically adjust the camera's focus mechanism based on the calculated representative focal point to facilitate capturing images with sharply focused target structures. Further, object detection CNNs can be trained to identify the eye, iris, pupil, and other anatomical structures. As to particular embodiments, the software can include modes, such as “cornea,” “lens,” and “sclera,” which may fine tune settings to optimize imaging for each anatomical landmark and / or target structure.

[0242] As to particular embodiments, during the image capture process, the software can facilitate focus stacking or capturing a burst of images in different focal planes and combining the most infocus region of each image to augment the depth of field of the image. As to particular embodiments, two to five images can be captured in different focal planes between about 0.10 meters (m) to about 0.8 m from the camera lens. As but one illustrative example, three images can be captured at about 0.20 m, about 0.27 m, and about 0.33 m from the camera lens. Following capture, the software can facilitate aligning and registering the images. The alignment algorithm can utilize feature extraction methods, such as key point detection and matching, to identify distinctive features within each image and determine the optimal transformation parameters needed to align them. Once aligned, the software can employ algorithms such as wavelet-based transforms or frequency domain analysis to identify the most in-focus regions within each image. The algorithm can analyze the sharpness and contrast of image details across different spatial frequencies to isolate the regions with optimal sharpness and detail. The software can then combine the in-focus regions from each image to create a composite image with extended depth of field. Depending on the specific implementation, additional algorithms such as gradient-based blending or depth-based weighting can be used to provide smooth transitions between the in-focus regions and out-of-focus regions in the final composite image.

[0243] As to particular embodiments, during the image capture process, the software can employ thresholds for assessing image focus and exposure which may be based upon eye color. As to particular embodiments, eye color can be determined by segmenting the iris, removing its outer about 12.5% and inner about 12.5%, and calculating the average pixel value of its middle about 75%. Subsequently, a focus and / or exposure threshold for the image can be calculated using this 1133P01T pixel value. Typically, darker-colored irises can have a lower focus threshold because their details may be less visible relative to lighter-colored irises.

[0244] As to particular embodiments, during the image capture process, the software can facilitate creating an extended depth of field by segmenting the image and selectively recombining key features. Initially, the iris and the pupil can be segmented from the most anterior-focused image in the stack. The segmentation can be performed using imaging processing or computer vision techniques, including thresholding, edge detection, circle fitting, region growing, or CNNs to accurately delineate the boundaries of these regions. A feature extraction algorithm can be employed to extract pertinent features such as size, position, shape, and texture descriptors from the segmented regions. The sclera and surrounding background can be replaced from the most posterior-focused image in the stack. Alignment and blending algorithms can be used to integrate the segmented iris and pupil of the anterior image with the surrounding structures of the posterior image to ensure precise alignment, natural transitions, and visual coherence in the final composite image.

[0245] As to particular embodiments, during the image capture process, the software can facilitate controlling the illumination modes, such as actuating the white light source (5), the blue light source (5), the slit lamp (19) (detailed below), and combinations thereof. However, the illumination modes need not be controlled by the software, and can instead be controlled by a manual switch (20) operably coupled to the corresponding light sources (as shown in Figures 12A through 12C).

[0246] Slit Lamp

[0247] As to particular embodiments, the eye imaging system can include a slit lamp (19) coupled to the optical assembly (7), whereby the housing (2) of the optical assembly (7) can be configured to removably couple to a portable camera as detailed above. Conveniently, the eye imaging system, including the optical assembly (7), the camera, and the slit lamp (19) can be portable. Such portability can permit use of the eye imaging system both within and outside of a clinical setting, such as in a remote location.

[0248] The slit lamp (19) can provide a slit beam (or a narrow, focused beam of light) which may transect the eye lens and enable grading of eye lens opacity and visualization of posterior subcapsular cataracts and cortical cataracts. Conventionally, manipulation of a slit beam can 1133P01T require extensive training and expertise. Beneficially, the present slit lamp (19) can allow effective visualization of ocular anatomy and pathology with a fixed position or limited movement, correspondingly requiring minimal training and expertise. Additionally, use of the present slit lamp (19) can be relatively simple and intuitive with a low skill barrier, thus permitting both trained eye care providers as well as those not trained in eye care provision to successfully capture effective images of the eye.

[0249] The slit beam can have a width (fixed or adjustable) of about 100 pm to about 2 mm, whereby as to particular embodiments, the slit beam can have a width of about 100 pm to about 1 mm. Also, the slit beam can have a length of about 4 mm to about 14 mm, whereby as to particular embodiments, the slit beam can have a length of about 6 mm to about 14 mm. Also, the slit beam can be configured to enter the eye at an angle of about 25° to about 60°, whereby as to particular embodiments, the slit beam can be configured to enter the eye at an angle of about 30° to about 45°. As but one illustrative example, the slit beam can have a fixed width of about 150 pm, a length of about 10 mm, and an angle of entry through the pupil of about 35°, whereby such a configuration may facilitate cross-sectional visualization of the eye lens for cataract grading. With a 35° angle of entry, the full depth of a 4 mm eye lens can be visualized through a pupil with a 2.5 mm diameter.

[0250] The slit lamp (19) can include a slit lamp light source (21) and a slit (22) through which light from the slit lamp light source (21) can pass to generate the slit beam. Further, the slit lamp (19) can include a slit lamp lens which may focus the slit beam on the eye. The slit lamp light source (21) can be a white slit lamp light source (21), for example an LED, having a color temperature of about 3,000 K to about 6,000 K, a viewing angle of not greater than about 90°, and a luminous flux of about 80 Im to about 200 Im, whereby as to particular embodiments, the luminous flux may be about 90 Im to about 120 Im. Further, the slit lamp light source (21) can have a luminous efficiency of not less than about 60 Im / W and a thermal resistance of not greater than about 12°C / W. As to particular embodiments, the slit lamp light source (21) can have a color temperature of about 3,200 K to about 4,500 K and a luminous efficiency of not less than about 100 Im / W.

[0251] One illustrative example of a white slit lamp light source (21) which can provide a slit beam may be a surface mount LED having a size of about 3 mm x about 3 mm with a height of about 2.13 mm, a viewing angle of about 80°, a color temperature of about 4,000 K, a luminous flux of about 95 Im at about 200 mA current, a luminous efficiency of about 117 Im / W, and a 1133P01T thermal resistance of about 5.25°C / W. Such a high-powered LED with a relatively narrow viewing angle can facilitate focusing the light through the slit (22) to provide an effectively bright slit beam.

[0252] Another illustrative example of a white slit lamp light source (21) which can provide a slit beam may be a through-hole LED with a bulb size of about 3 mm, a viewing angle of about 40°, a color temperature of about 4,000 K, and a luminous flux of about 35 Im at about 200 mA. This example uses a lower power LED with a reduced viewing angle to facilitate focusing light through the slit (22) to provide a bright slit beam.

[0253] As to particular embodiments, a slit lamp (19) which can generate a slit beam at a desired angle may include a white slit lamp light source (21), for example an LED, positioned to reflect its light off of a first mirror (23) (such as a curved mirror) which condenses the light and directs it to pass through a slit (22) to generate a slit beam. A second mirror (24) (such as a flat mirror) can be positioned to reflect the slit beam into the eye. A first lens (25) can be located between the second mirror (24) and the eye to focus the reflected slit beam on the eye. As to particular embodiments, prior to passing through the slit (22), the light can pass through a second lens which condenses the light or collimates the light (such as a Fresnel lens or a bi-convex lens with a focal length of less than about 10 mm) (not shown).

[0254] An illustrative example of the above-detailed embodiment is shown in Figures 19A through 20C. The slit lamp LED (21) can be positioned below and in line with the camera lens at various distances on a primary axis (26); for example, the slit lamp LED (21) may be positioned a distance of about 20.7 mm from the camera lens. The base of the first mirror (23) can be positioned up to about 11 mm from the slit lamp LED (21); for example, the base of the first mirror (23) may be positioned about 4.5 mm from the slit lamp LED (21). Additionally, the first mirror (23) can be positioned at an angle of about 30° to about 55° relative to the primary axis (26); for example, the first mirror (23) may be positioned at an angle of about 42° relative to the primary axis (26). The first mirror (23) can be a curved mirror, such as a spherical or cylindrical mirror, with a focal length of about 3 mm to about 12 mm and a diameter or length, respectively, of about 9 mm to about 25 mm; for example, the first mirror (23) may be a spherical mirror with a focal length of about 6.0 mm and a diameter of about 12.0 mm.

[0255] The slit (22) can be positioned up to about 22 mm from the apex of the first mirror (23); for example, the slit (22) may be positioned about 8 mm from the apex of the first mirror (23). The slit (22) can have a fixed or adjustable width of about 100 pm to about 1 mm; for example, the slit 1133P01T

[0256] (22) may have a width of about 150 pm. Also, the slit (22) can have a length of about 6 mm to about 14 mm; for example, the slit (22) may have a length of about 10 mm. Moreover, the slit (22) can have a thickness of about 200 pm to about 1 mm; for example, the slit (22) may have a thickness of about 400 pm.

[0257] The second mirror (24) can be a flat mirror positioned about 3 mm to about 18 mm from the slit (22); for example, the second mirror (24) may be positioned about 4.6 mm from the slit (22). Additionally, the second mirror (24) can be positioned at an angle of about 15° to about 32.5° relative to the primary axis (26) to achieve a resulting angle of entry into the eye of about 15° to about 60°; for example, the second mirror (24) may be positioned at an angle of about 27.5° relative to the primary axis (26).

[0258] A first lens (25) can be positioned at various distances from the second mirror (24) to focus the reflected slit beam on the eye; for example, the first lens (25) may be positioned about 5.2 mm from the second mirror (24). Additionally, the first lens (25) can be positioned at an angle of about 25° to about 60° relative to the primary axis (26); for example, the first lens may be positioned at an angle of about 35° relative to the primary axis (26).

[0259] The first lens (25) can be a cylindrical or spherical lens, with a focal length of up to about 20 mm, whereby the distance between the first lens (25) and the slit (22) may vary based on the focal length of the first lens (25). As to particular embodiments, the first lens (25) can have a focal length of less than about 9 mm, and the distance between the slit (22) and the eye can be at least about 1.5 times the focal length to achieve an effective depth of field to visual a cross-section of the entire eye lens. For example, the first lens (25) can be a plano-convex cylindrical lens with a focal length of about 6.4 mm, a length of about 8 mm, and a radius of curvature of about 3.3 mm. The slit beam can travel about 20 mm from the center of the first lens (25) to focus the slit beam on the eye lens. The image of the slit (22) can be magnified about 2 times such that the imaged slit may be about 300 pm wide.

[0260] As to other particular embodiments, a slit lamp (19) which can generate a slit beam at a desired angle may include a white slit lamp light source (21), for example an LED, positioned to reflect its light off of a first mirror (23) (such as a flat mirror) which directs the light to pass through a first lens (25) (such as a collimating lens) which collimates the light and directs it to pass through a slit (22) to generate a slit beam. A second mirror (24) (such as a flat mirror) can be positioned to reflect the slit beam into the eye. A second lens (27) (such as a condensing lens) can be located 1133P01T between the slit (22) and the second mirror (24) to focus the slit beam on the second mirror (24) for subsequent reflection into the eye.

[0261] An illustrative example of the above-detailed embodiment is shown in Figures 21 Athrough 21C. The slit lamp LED (21) can be positioned below the camera lens on a primary axis (26). The first lens (25) can be positioned such that the distance between the slit lamp LED (21) and its center may be about 1.33 to about 1.5 times its focal length. The first lens (25) can be a collimating cylindrical or spherical lens, with a focal length of about 3 mm to about 20 mm, whereby the focal length may be not greater than about 1.3 times the minimum cross-section dimension to maximize light collection. For example, the first lens (25) can be a plano-convex cylindrical lens with a focal length of about 3.9 mm, a width of about 4 mm, a height of about 6 mm, and a radius of curvature of about 2 mm; the center of this lens may be positioned about 5.87 mm from the slit lamp LED

[0262] (21). Light can be directed from the slit lamp LED (21) to the first lens (25) via the first mirror

[0263] (23).

[0264] The slit (22) can be positioned such that its distance from the first lens (25) may be about 1 to about 3 times the distance between the slit lamp LED (21) and the first lens (25); for example, the slit (22) can be positioned about 9.5 mm from the first lens (25). The slit (22) can have a width of about 100 pm to about 2 mm and a length of about 6 mm to about 12 mm; for example, the slit

[0265] (22) may have a width of about 150 pm and a length of about 10 mm.

[0266] The second lens (27) can be positioned such that the distance between the slit (22) and its center may be about 1.33 to about 2 times its focal length. The second lens (27) can be a condensing cylindrical or spherical lens, with a focal length of about 10 mm to about 30 mm; for example, the second lens (27) may be a plano-convex cylindrical lens with a focal length of about 15 mm; the center of this lens can be positioned about 22.5 mm from the slit (22). The distance from the second lens (27) to the eye can be about 2 to about 4 times its focal length; for example, the distance from the second lens (27) to the eye can be about 45 mm.

[0267] The second mirror (24) can be a flat mirror positioned below and in line with the camera lens at various distances on a primary axis (26); for example, the second mirror (24) may be positioned a distance of about 12.5 mm from the camera lens. Additionally, the second mirror (24) can be positioned at various distances from the second lens (27); for example, the second mirror

[0268] (24) may be positioned about 25.7 mm from the second lens (27). Further, the second mirror (24) can be positioned at an angle of about 15° to about 32.5° relative to the primary axis (26) to achieve 1133P01T a resulting angle of entry into the eye of about 25° to about 60°; for example, the second mirror (24) may be positioned at an angle of about 25° relative to the primary axis (26). The reflected slit beam can travel about 19.7 mm from the second mirror (24) to the surface of the eye. Figure 22 shows an image of an eye with a mature cataract captured with this embodiment of the eye imaging system.

[0269] As to other particular embodiments, a slit lamp (19) which can generate a slit beam at a desired angle may include a white slit lamp light source, for example an LED, positioned generally perpendicular to the camera lens optical axis; as to particular embodiments, the slit lamp LED can have an exemplary viewing angle of about 50°. A slit can be positioned about 3 mm from the proximal end of the slit lamp LED, whereby the slit can have an exemplary width of about 150 pm.

[0270] A first lens can be configured as a cylindrical lens with a focal length of about 15 mm, whereby the center of this lens can be positioned about 22.5 mm from the slit. A first mirror configured as a flat mirror can be positioned about 19 mm from the first lens, whereby the first mirror can be positioned at an angle of about 25° relative to a primary axis. The slit beam can reflect off of the first mirror at an angle of about 50° to achieve a resulting angle of entry into the eye of about 40°. Light can travel about 45 mm from the slit lamp LED to the surface of the eye.

[0271] Now referring primarily to Figures 23 A through 26, as to other particular embodiments, a slit lamp (19) which can generate a slit beam at a desired angle may include a white slit lamp light source (21), for example an LED, positioned generally perpendicular to the camera lens optical axis. A first lens (25) can be positioned such that a distance from its center to the slit lamp LED (21) may be not greater than its focal length. The first lens (25) can be a collimating cylindrical or spherical lens with a focal length of about 3 mm to about 15 mm. For example, the first lens (25) can be a plano-convex cylindrical lens with a focal length of about 6.4 mm, a width of about 6 mm, a height of about 8 mm, and a radius of curvature of about 3.3 mm. The center of the first lens (25) can be positioned about 4.5 mm from the slit lamp LED (21).

[0272] A slit (22) can be positioned a distance from the first lens (25) of not greater than about 1.5 times its focal length; for example, the slit (22) can be positioned about 6.5 mm from the center of the first lens (25). The slit (22) can have a width of about 100 pm to about 2 mm and a length of about 7 mm to about 14 mm; for example, the slit (22) may have a width of about 150 pm and a length of about 10 mm. 1133P01T

[0273] A second lens (27) can be configured as a plano-convex cylindrical lens with a focal length of about 15 mm, whereby the center of this lens can be positioned about 22.5 mm from the slit (22). The distance from the second lens (27) to the eye can be about 2 times to about 4 times its focal length; for example, the distance from the second lens (27) to the eye may be about 37 mm.

[0274] A first mirror (23) can be a flat mirror positioned below and in line with the camera lens at various distances on a primary axis (26); for example, the center of the first mirror (23) may be positioned a distance of about 15 mm from the camera lens. Additionally, the first mirror (23) can be positioned at various distances from the second lens (27); for example, the first mirror (23) may be positioned about 13 mm from the second lens (27). Further, the first mirror (23) can be positioned at an angle of about 15° to about 32.5° relative to the primary axis (26) to achieve a resulting angle of entry into the eye of about 25° to about 60°; for example, the first mirror (23) may be positioned at an angle of about 25° relative to the primary axis (26). The reflected slit beam can travel about 24 mm from the first mirror (23) to the surface of the eye.

[0275] As to other particular embodiments, a slit lamp (19) which can generate a slit beam at a desired angle may include a white slit lamp light source, for example an LED, positioned generally perpendicular to the camera lens optical axis. An illustrative example of this embodiment is shown in Figures 27A through 28, which includes a slit (22) positioned a distance from the slit lamp LED (21) of not greater than about 6 mm to maximize the amount of light passing through the slit (22). This distance can be adjusted based on the brightness and / or viewing angle of the slit lamp LED

[0276] (21); for example, the slit (22) can be positioned about 1 mm from the slit lamp LED (21). The slit

[0277] (22) can have a width of about 100 pm to about 2 mm and a length of about 7 mm to about 14 mm; for example, the slit (22) may have a width of about 150 pm and a length of about 10 mm.

[0278] A first lens (25) can be configured as a compound sphero-cylindrical optical element which may include a cylindrical lens component and a spherical lens component that are optically aligned along a common axis. As to particular embodiments, the cylindrical component can have a focal length of about 50 mm and may be configured to focus light along a single axis to form a linear image corresponding to the slit (22). The spherical component can have a focal length of about 30 mm and may be configured to provide convergent focusing along the orthogonal axis. The cylindrical lens component and the spherical lens component can be provided as two discrete lenses in optical contact or may be an integrated, single-piece, molded or ground lens with the 1133P01T desired optical power. The focal length of the first lens (25) can be selected to achieve the desired slit beam shape and convergence at the plane of observation and / or imaging.

[0279] A first surface of the first lens (25) can be positioned about 15 mm to about 40 mm from the slit (22); for example, the first surface may be positioned about 30.5 mm from the slit (22). The opposing second surface of the first lens (25) can be positioned about 25 mm to about 55 mm from the eye; for example, the second surface can be positioned about 43.5 mm from the eye. These distances can be adjusted depending on the optical power, focal length, and desired slit image quality to optimize beam collimation, illumination uniformity, and focus at the plane of the eye.

[0280] A first mirror (23) can be a flat mirror positioned below and in line with the camera lens at various distances on a primary axis (26); for example, the center of the first mirror (23) may be positioned about 15 mm from the camera lens. Additionally, the first mirror (23) can be positioned at various distances from the first lens (25); for example, the first mirror (23) may be positioned about 19.5 mm from the first lens (25). Further, the first mirror (23) can be positioned at an angle of about 15° to about 32.5° relative to the primary axis (26) to achieve a resulting angle of entry into the eye of about 25° to about 60°; for example, the first mirror (23) may be positioned at an angle of about 25° relative to the primary axis (26). The reflected slit beam can travel about 24 mm from the first mirror (23) to the surface of the eye.

[0281] Other embodiments of slit lamps (19) are, of course, herein contemplated and can use lenses and mirrors having various parameters, whereby the positions of the lens(es), mirror(s), slit, and eye can be adjusted accordingly.

[0282] Again referring primarily to Figures 23 A through 26, as to particular embodiments of the eye imaging system which include a slit lamp (19), the housing (2) of the optical assembly (7) can be configured to accommodate the optical path of the slit beam. As but one illustrative example of such as embodiment, the housing (2) of the optical assembly (7) can align with the slit lamp housing (28); correspondingly, aligning pass-throughs (29) can be disposed in the slit lamp housing (28) and the housing (2) of the optical assembly (7) to allow the slit beam to pass therethrough to enter the eye at an effective angle, whereby the pass-throughs (29) can be sufficiently sized to accommodate the width and length of the slit beam. As to particular embodiments, the PCB (10) can include a sufficiently sized aligning pass-through (29) which also allows the slit beam to pass therethrough to enter the eye at an effective angle. 1133P01T

[0283] Regarding the slit lamp housing (28) which houses the slit lamp (19), as to particular embodiments, it can be sufficiently large such that light does not significantly interact with its interior wall(s) to preclude generation of light artifacts which may be produced from reflection of light off of said wall(s). As but one illustrative example, as to the particular embodiment shown in Figures 19A through 20C, the slit beam exiting the slit (22) can spread about 27.4° (about 13.7° degrees from center on either side); correspondingly, the slit lamp housing (28) can have a width of not less than about 10.2 mm to prevent light from interacting with its interior wall(s). As to particular embodiments, one or more barriers can be disposed within the slit lamp housing (28) to block peripheral light and thus, eliminate light artifacts therefrom.

[0284] Diagnosis

[0285] As to particular embodiments, the software can facilitate algorithm-assisted preliminary diagnoses or referrals based on the captured eye images and / or subject data (such as clinical information including visual acuity, best-corrected visual acuity, complaints, age, gender, comorbidities, demographic information, and medical history) via models such as ResNet, EfficientNet, MobileNet, and other CNNs.

[0286] As to particular embodiments, the software can utilize an artificial intelligence algorithm based on accumulated observation and / or examination data for preliminary diagnoses, which may improve the efficiency and accuracy of the diagnostic process. For example, artificial intelligencebased diagnoses can employ an algorithm to segment key structures in the image, such as the eye lens, iris, and pupil, using a residual neural network, for example You Only Look Once (YOLO) or Segment Anything, to enhance the specificity of the diagnostic algorithm and limit bias caused by variations between subjects or locations. Artificial intelligence-based diagnoses can further employ an algorithm to classify the image, analyze clinical data, and use the combined information to provide a preliminary diagnosis, such as regarding lens pathology (clear lens, early cataract, immature cataract, mature cataract, pseudophakia, or aphakia), and common anterior segment pathology (conjunctivitis, corneal opacity, infectious keratitis, pterygium, refractive error, etc.). As to particular embodiments, the software can provide a confidence score with the preliminary diagnosis.

[0287] As to particular embodiments, the software can include a multi-modal model which predicts the diagnosis using clinical, non-image-based factors. The output of the image-based 1133P01T algorithm and the non-image-based algorithm can be weighted using a Decision Tree to produce a confidence score.

[0288] As to particular embodiments, the software can facilitate telemedicine examinations (for example via a live telemedicine feed or a telemedicine exchange) by guiding the user, who may not be a trained eye care provider, through a structured process. Subsequently, the captured eye images, and optionally patient information and clinical data, can be provided to an ophthalmologist for remote assessment, such as via cloud-based transmission of data. As to particular embodiments, the images can have a resolution of at least about 1,280 pixels x 720 pixels for effective examination of anatomy and pathology.

[0289] Posterior Segment Imaging

[0290] As to particular embodiments, an indirect ophthalmoscope can be removably coupled to the camera to provide the eye imaging system for visualization of the posterior segment, including the central and peripheral retina, optic disc, macula, retinal blood vessels, choroid, and vitreous cavity. The ophthalmoscope can be employed to identify posterior segment diseases, including retinal detachment, macular degeneration, diabetic retinopathy, glaucoma, retinal vascular diseases, retinitis pigmentosa, retinal tears and damage, retinoblastoma or other intraocular tumors, endophthalmitis, and choroidal disorders. Additionally, the ophthalmoscope can be employed to assess post-operative health following retinal detachment repair, vitrectomy, and other retinal surgeries. Moreover, the ophthalmoscope can be employed to assess progression of chronic disease, including diabetic retinopathy, age-related macular degeneration, glaucoma, retinitis pigmentosa, and vascular disease.

[0291] The indirect ophthalmoscope can include an optical ophthalmoscope lens, whereby upon coupling to the camera, the ophthalmoscope lens may dispose along the camera lens optical axis. The ophthalmoscope lens can be spherical or aspherical with a power of about 10 diopters to about 90 diopters and a diameter of about 12.7 mm to about 80 mm. Additionally, the ophthalmoscope lens can be positioned about 2 centimeters (cm) to about 20 cm from the eye and about 10 cm to about 60 cm from the camera lens, whereby the positioning may be based on the power of the ophthalmoscope lens. The distance between the ophthalmoscope lens and camera lens can be fixed or adjustable via an adjustable arm, such as a telescoping arm. Further, the ophthalmoscope lens can be stationary or adjustable such that it can be positioned along or outside of the camera lens optical axis, such as via a hinge, slide, or detachable mechanism. The ophthalmoscope can also 1133P01T include a light source (5), such as an LED, positioned proximate or along the ophthalmoscope lens optical axis.

[0292] Use

[0293] The present eye imaging system can be used to identify a variety of anterior segment conditions, including but not limited to cataracts (such as nuclear cataracts, cortical cataracts, and posterior subcapsular cataracts), eye lens status (such as clear lens, pseudophakia, aphakia, and posterior capsular opacification), corneal disorders (such as corneal opacity, corneal scarring, pseudophakic bullous keratopathy, band keratopathy, corneal dystrophy or degeneration, trauma, corneal abrasions, corneal lacerations, laceration, presence of foreign bodies, and infectious keratitis (such as fungal, viral, bacterial, and parasitic infections)), glaucoma, ocular inflammatory disorders (such as iritis and uveitis), conjunctivitis, pterygium, ocular surface lesions, ocular surface diseases, inflammatory conditions of the sclera (such as scleritis and episcleritis), anterior segment ischemia, endothelial cell disorders (including Fuchs’ dystrophy), keratoconus, dry eye syndrome, orbital disorders (such as thyroid eye disease and orbital inflammation), eyelid edema, infections, tumors, trauma, ptosis, ocular and eyelid burns, eyelid disorders (such as blepharitis, Meibomian gland dysfunction, chalazia, hordeolum, benign eyelid lesions, and malignant eyelid lesions), and mechanical disorders (such as trichiasis, entropion, ectropion, and palsy). The eye imaging system can also be used to assess progression of the above and monitor the outcome of interventions for the above.

[0294] Additionally, the present eye imaging system can be used to grade the stage of cataracts on a classification scale such as LOCS III. Also, the present eye imaging system can be used to identify the presence of an abnormal cataract (such as a congenital or traumatic cataract) and lens subluxation to inform cataract surgical planning.

[0295] Further, the present eye imaging system can be used for post-operative follow-up of cataract surgery and corneal surgery. For cataract surgery follow-ups, the eye imaging system can be used to assess anterior chamber depth and the presence of corneal edema or hypopyon, and to evaluate intraocular lens (IOL) position. For corneal and / or ocular surgery follow-ups, the eye imaging system can be used to assess corneal clarity and the presence of corneal edema, identify the presence of inflammation or infection, assess stitch tightness, assess the surgical wound, and identify wound leakage. 1133P01T

[0296] In addition, the present eye imaging system can be used to assess the suitability of a donor cornea for transplantation. As illustrative examples, for transplantation suitability, the present eye imaging system can be used to assess corneal thickness and clarity, identify the presence of edema, opacities, arcus, and hypopyon, and identify the presence of anterior segment comorbidities.

[0297] Moreover, as a result of the high resolution of the iris in images or videos captured with the present eye imaging system, it can also be used for iris recognition and authentication.

[0298] The present eye imaging system can be used in a variety of clinical and non-clinical settings, including but not limit to optometry and ophthalmology offices, emergency departments, inpatient hospital facilities, intensive care units, primary care facilities, community eye clinics including vision centers, ambulatory surgical centers, home settings, nursing homes, senior living facilities, veterinary clinics, or for community screening.

[0299] As can be easily understood from the foregoing, the basic concepts of the present invention may be embodied in a variety of ways. The invention involves numerous and varied embodiments of an eye imaging system and methods of making and using the same.

[0300] As such, the particular embodiments or elements of the invention disclosed by the description or shown in the figures or tables accompanying this application are not intended to be limiting, but rather exemplary of the numerous and varied embodiments generically encompassed by the invention or equivalents encompassed with respect to any particular element thereof. In addition, the specific description of a single embodiment or element of the invention may not explicitly describe all embodiments or elements possible; many alternatives are implicitly disclosed by the description and figures.

[0301] It should be understood that each element of an apparatus or each step of a method may be described by an apparatus term or method term. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled. As but one example, it should be understood that all steps of a method may be disclosed as an action, a means for taking that action, or as an element which causes that action. Similarly, each element of an apparatus may be disclosed as the physical element or the action which that physical element facilitates. As but one example, the disclosure of a “coupler” should be understood to encompass disclosure of the act of “coupling” — whether explicitly discussed or not — and, conversely, were there effectively disclosure of the act of “coupling,” such a disclosure should be understood to encompass 1133P01T disclosure of a “coupler” and even a “means for coupling.” Such alternative terms for each element or step are to be understood to be explicitly included in the description.

[0302] In addition, as to each term used it should be understood that unless its utilization in this application is inconsistent with such interpretation, common dictionary definitions should be understood to be included in the description for each term as contained in the Random House Webster’s Unabridged Dictionary, second edition, each definition hereby incorporated by reference.

[0303] All numeric values herein are assumed to be modified by the term “about”, whether or not explicitly indicated. For the purposes of the present invention, ranges may be expressed as from “about” one particular value to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value to the other particular value. The recitation of numerical ranges by endpoints includes all the numeric values subsumed within that range. A numerical range of one to five includes for example the numeric values 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so forth. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. When a value is expressed as an approximation by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. The term “about” generally refers to a range of numeric values that one of skill in the art would consider equivalent to the recited numeric value or having the same function or result. Similarly, the antecedent “substantially” means largely, but not wholly, the same form, manner or degree and the particular element will have a range of configurations as a person of ordinary skill in the art would consider as having the same function or result. When a particular element is expressed as an approximation by use of the antecedent “substantially,” it will be understood that the particular element forms another embodiment.

[0304] Moreover, for the purposes of the present invention, the term “a” or “an” entity refers to one or more of that entity unless otherwise limited. As such, the terms “a” or “an”, “one or more” and “at least one” can be used interchangeably herein.

[0305] Thus, the applicant(s) should be understood to claim at least: i) each of the eye imaging systems and methods for making and using the same herein disclosed and described, ii) the related methods disclosed and described, iii) similar, equivalent, and even implicit variations of each of these devices and methods, iv) those alternative embodiments which accomplish each of the functions shown, disclosed, or described, v) those alternative designs and methods which 1133P01T accomplish each of the functions shown as are implicit to accomplish that which is disclosed and described, vi) each feature, component, and step shown as separate and independent inventions, vii) the applications enhanced by the various systems or components disclosed, viii) the resulting products produced by such systems or components, ix) methods and apparatuses substantially as described hereinbefore and with reference to any of the accompanying examples, x) the various combinations and permutations of each of the previous elements disclosed.

[0306] The background section of this patent application, if any, provides a statement of the field of endeavor to which the invention pertains. This section may also incorporate or contain paraphrasing of certain United States patents, patent applications, publications, or subject matter of the claimed invention useful in relating information, problems, or concerns about the state of technology to which the invention is drawn toward. It is not intended that any United States patent, patent application, publication, statement or other information cited or incorporated herein be interpreted, construed or deemed to be admitted as prior art with respect to the invention.

[0307] The claims set forth in this specification, if any, are hereby incorporated by reference as part of this description of the invention, and the applicant expressly reserves the right to use all of or a portion of such incorporated content of such claims as additional description to support any of or all of the claims or any element or component thereof, and the applicant further expressly reserves the right to move any portion of or all of the incorporated content of such claims or any element or component thereof from the description into the claims or vice-versa as necessary to define the matter for which protection is sought by this application or by any subsequent application or continuation, division, or continuation-in-part application thereof, or to obtain any benefit of, reduction in fees pursuant to, or to comply with the patent laws, rules, or regulations of any country or treaty, and such content incorporated by reference shall survive during the entire pendency of this application including any subsequent continuation, division, or continuation-in-part application thereof or any reissue or extension thereon.

[0308] Additionally, the claims set forth in this specification, if any, are further intended to describe the metes and bounds of a limited number of the preferred embodiments of the invention and are not to be construed as the broadest embodiment of the invention or a complete listing of embodiments of the invention that may be claimed. The applicant does not waive any right to develop further claims based upon the description set forth above as a part of any continuation, division, or continuation-in-part, or similar application. 1133P01T

[0309] Unless stated otherwise, any claim element described herein may be combined with any other claim element, and the invention includes all combinations and subcombinations of the features described.

Claims

1. 1133P01TIV. CLAIMS1. An eye imaging system, comprising: a magnifying lens housed within a housing having a housing proximal end and an opposing housing distal end; a light source housed within said housing; and a subject interface coupled to said housing proximate said housing distal end; wherein said housing is configured to removably couple to a portable camera proximate said housing proximal end; wherein said camera comprises a camera lens with a camera lens optical axis; and wherein upon coupling of said housing and said camera, said magnifying lens disposes along said camera lens optical axis.

2. The eye imaging system of claim 1, wherein said magnifying lens, said housing, said light source, and said subject interface constitute an optical assembly; wherein said optical assembly is handheld; and wherein said optical assembly removably couples to said camera.

3. The eye imaging system of claim 1, wherein said magnifying lens, said housing, said light source, and said subject interface constitute an optical assembly; wherein said optical assembly is portable; and wherein said optical assembly removably couples to said camera.

4. The eye imaging system of claim 1, wherein said magnifying lens, said housing, said light source, and said subject interface constitute an optical assembly; wherein said optical assembly and said camera facilitate capturing one or more magnified and in-focus images of one or more target structures of an eye of a subject.

5. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, a magnifying lens optical axis of said magnifying lens is substantially coaxial with said camera lens optical axis.

6. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, a magnifying lens optical axis of said magnifying lens and said camera lens optical axis are substantially coincident.1133P01T7. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes about 2 millimeters to about 50 millimeters from said camera lens.

8. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 50 millimeters from said camera lens.

9. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 40 millimeters from said camera lens.

10. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 30 millimeters from said camera lens.

11. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 25 millimeters from said camera lens.

12. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 20 millimeters from said camera lens.

13. The eye imaging system of claim 1, wherein upon coupling of said housing and said camera, said magnifying lens disposes not greater than about 10 millimeters from said camera lens.

14. The eye imaging system of claim 1, wherein a diameter of said magnifying lens is greater than an aperture diameter of said camera.

15. The eye imaging system of claim 14, wherein said diameter of said magnifying lens is at least about 20% greater than said aperture diameter.

16. The eye imaging system of claim 1, wherein a diameter of said magnifying lens is about 6 millimeters to about 50 millimeters.

17. The eye imaging system of claim 1, wherein a central thickness of said magnifying lens is about 3 millimeters to about 6 millimeters.1133P01T18. The eye imaging system of claim 1, wherein a focal length of said magnifying lens is about 15 millimeters to about 80 millimeters.

19. The eye imaging system of claim 1, wherein a focal length of said magnifying lens is about 20 millimeters to about 50 millimeters.

20. The eye imaging system of claim 1, wherein said magnifying lens comprises an anti- reflective coating which reduces reflectance of visible light.

21. The eye imaging system of claim 1, wherein said magnifying lens comprises an aspherical lens.

22. The eye imaging system of claim 1, wherein said magnifying lens comprises a spherical lens.

23. The eye imaging system of claim 1, wherein said magnifying lens comprises an intraocular lens.

24. The eye imaging system of claim 23, wherein said intraocular lens comprises a power of about 5 diopters to about 20 diopters.

25. The eye imaging system of claim 23, wherein said intraocular lens comprises a power of about 8 diopters to about 12 diopters.

26. The eye imaging system of claim 1, further comprising one or more supplementary lenses disposed along said camera lens optical axis proximate said magnifying lens.

27. The eye imaging system of claim 26, wherein said supplementary lenses are interchangeable.

28. The eye imaging system of claim 1, wherein said light source comprises a light-emitting diode.

29. The eye imaging system of claim 28, wherein said light-emitting diode has a size of not greater than about 25 mm2.1133P01T30. The eye imaging system of claim 1, wherein said light source disposes about a perimeter of said magnifying lens.

31. The eye imaging system of claim 30, wherein said light source comprises a white light source.

32. The eye imaging system of claim 31, wherein said white light source comprises a color temperature of about 3,500 K to about 4,200 K.

33. The eye imaging system of claim 31, wherein said white light source provides for at least about 250,000 lux entering an anterior chamber of an eye.

34. The eye imaging system of claim 31, wherein said white light source comprises a luminosity of about 35 lumens to about 120 lumens.

35. The eye imaging system of claim 31, wherein said white light source has a viewing angle of about 70° to about 150°.

36. The eye imaging system of claim 31, wherein said white light source is disposed to position a light source axis of said white light source radially outward from said magnifying lens optical axis a distance of about 6 millimeters to about 50 millimeters.

37. The eye imaging system of claim 31, wherein said light source comprises at least two said white light sources.

38. The eye imaging system of claim 37, wherein said two white light sources dispose in opposed spaced-apart relation.

39. The eye imaging system of claim 38, wherein said two white light sources dispose about 25 millimeters apart.

40. The eye imaging system of claim 31, wherein when imaging, said white light source is positioned to dispose a light source axis of said white light source proximate a margin of a pupil of an eye.1133P01T41. The eye imaging system of claim 40, wherein when imaging, said white light source is positioned to align said light source axis with said margin.

42. The eye imaging system of claim 40, wherein when imaging, said white light source is positioned to dispose said light source axis radially outward from said margin.

43. The eye imaging system of claim 42, wherein when imaging, said white light source is positioned to dispose said light source axis radially outward from said margin a distance of about 1 millimeter to about 5 millimeters.

44. The eye imaging system of claim 31, wherein when imaging, said white light source disposes an axial distance of about 10 millimeters to about 55 millimeters from an apex of an eye.

45. The eye imaging system of claim 30, wherein said light source comprises a blue light source.

46. The eye imaging system of claim 45, wherein said blue light source comprises a wavelength of about 430 nanometers to about 470 nanometers.

47. The eye imaging system of claim 45, wherein said blue light source comprises a luminosity of about 10 lumens to about 120 lumens.

48. The eye imaging system of claim 46, wherein said light source comprises at least two said blue light sources.

49. The eye imaging system of claim 48, wherein said two blue light sources dispose in opposed spaced-apart relation.

50. The eye imaging system of claim 30, wherein said light source comprises at least one white light source and at least one blue light source.

51. The eye imaging system of claim 30, wherein said light source comprises a multicolored light source.1133P01T52. The eye imaging system of claim 1, wherein said light source is powered by a power source.

53. The eye imaging system of claim 52, wherein said power source is housed within said housing.

54. The eye imaging system of claim 52, wherein said power source is provided by a smartphone which includes said camera.

55. The eye imaging system of claim 1, wherein said light source is mounted on a printed circuit board housed within said housing.

56. The eye imaging system of claim 1, wherein a subject interface distal end of said subject interface is configured to engage with a face of a subject around an eye of said subject.

57. The eye imaging system of claim 1, wherein said subject interface comprises a resiliently compressible material.

58. The eye imaging system of claim 1, wherein said subject interface comprises a length extending between subject interface proximal and distal ends; wherein said length is about 8 millimeters to about 35 millimeters.

59. The eye imaging system of claim 1, wherein said subject interface comprises a diameter of about 32 millimeters to about 60 millimeters.

60. The eye imaging system of claim 1, wherein said camera is coupled to a mobile computing device.

61. The eye imaging system of claim 60, wherein said mobile computing device comprises a mobile phone.

62. The eye imaging system of claim 60, wherein said mobile computing device comprises a smartphone.1133P01T63. The eye imaging system of claim 1, further comprising a pupil centration system which facilitates locating an eye and a pupil in a center of an image for imaging.

64. The eye imaging system of claim 63, wherein said pupil centration system utilizes a reflection of said light source.

65. The eye imaging system of claim 1, further comprising a fixation target.

66. The eye imaging system of claim 1, further comprising software which guides an image capture process to facilitate acquisition of an optimal image.

67. The eye imaging system of claim 1, further comprising software which optimizes image quality.

68. The eye imaging system of claim 1, further comprising a slit lamp.

69. The eye imaging system of claim 68, wherein said slit lamp provides a slit beam.

70. The eye imaging system of claim 69, wherein said slit beam comprises a width of about 100 micrometers to about 1 millimeter.

71. The eye imaging system of claim 69, wherein said slit beam comprises a length of about 4 mm to about 14 mm.

72. The eye imaging system of claim 69, wherein said slit beam is configured to enter an eye at an angle of about 25° to about 60°.

73. The eye imaging system of claim 69, wherein said slit lamp comprises a slit lamp light source and a slit through which light from said slit lamp light source passes to generate said slit beam.

74. The eye imaging system of claim 73, wherein said slit lamp further comprises a first mirror positioned to reflect light from said slit lamp light source to generate said slit beam.1133P01T75. The eye imaging system of claim 74, wherein said slit lamp further comprises a second mirror positioned to reflect said slit beam into an eye.

76. The eye imaging system of claim 75, wherein said first mirror comprises a curved mirror.

77. The eye imaging system of claim 75, wherein said second mirror comprises a flat mirror.

78. The eye imaging system of claim 75, wherein said slit lamp further comprises a lens located between said second mirror and said eye.

79. The eye imaging system of claim 78, wherein said lens comprises a curved lens.

80. The eye imaging system of claim 73, wherein said slit lamp further comprises a first mirror positioned to reflect light from said slit lamp light source to generate said slit beam.

81. The eye imaging system of claim 80, wherein said slit lamp further comprises a second mirror positioned to reflect said slit beam into an eye.

82. The eye imaging system of claim 81, wherein said first mirror comprises a flat mirror.

83. The eye imaging system of claim 81, wherein said second mirror comprises a flat mirror.

84. The eye imaging system of claim 81, wherein said slit lamp further comprises a first lens located between said first mirror and said slit.

85. The eye imaging system of claim 84, wherein said first lens comprises a curved lens.

86. The eye imaging system of claim 84, wherein said slit lamp further comprises a second lens located between said slit and said second mirror.

87. The eye imaging system of claim 86, wherein said second lens comprises a curved lens.

88. The eye imaging system of claim 73, wherein said slit lamp further comprises a lens located between said slit and a mirror.1133P01T89. The eye imaging system of claim 88, wherein said mirror is positioned to reflect said slit beam into an eye.

90. The eye imaging system of claim 88, wherein said lens comprises a curved lens.

91. The eye imaging system of claim 88, wherein said mirror comprises a curved mirror.

92. The eye imaging system of claim 73, wherein said slit lamp further comprises a first lens located between said slit lamp light source and said slit.

93. The eye imaging system of claim 92, wherein said first lens comprises a curved lens.

94. The eye imaging system of claim 92, wherein said slit lamp further comprises a second lens located between said slit and a mirror.

95. The eye imaging system of claim 94, wherein said second lens comprises a curved lens.

96. The eye imaging system of claim 94, wherein said mirror is positioned to reflect said slit beam into an eye.

97. The eye imaging system of claim 94, wherein said mirror comprises a flat mirror.

98. The eye imaging system of claim 73, wherein said slit lamp further comprises a lens located between said slit and a mirror.

99. The eye imaging system of claim 98, wherein said mirror is positioned to reflect said slit beam into an eye.

100. The eye imaging system of claim 98, wherein said lens comprises a curved lens.

101. The eye imaging system of claim 98, wherein said lens comprises a compound spherocylindrical optical element.

102. The eye imaging system of claim 98, wherein said mirror comprises a flat mirror.1133P01T103. The eye imaging system of claim 69, wherein said housing is configured to accommodate an optical path of said slit beam.

104. The eye imaging system of claim 1, further comprising software which facilitates a diagnosis.

105. The eye imaging system of claim 1, further comprising software which facilitates a referral.

106. The eye imaging system of claim 1, further comprising software which facilitates a telemedicine examination.

107. The eye imaging system of claim 1, further comprising software which facilitates collection of subject data.

108. The eye imaging system of claim 107, wherein said subject data comprises one or more of visual acuity, best-corrected visual acuity, complaints, age, gender, comorbidities, demographic information, and medical history.

109. The eye imaging system of claim 1, further comprising an optical ophthalmoscope lens for visualization of a posterior segment of an eye.

110. A method of making an eye imaging system, comprising: housing a magnifying lens within a housing having a housing proximal end and an opposing housing distal end; housing a light source within said housing; and coupling a subject interface to said housing proximate said housing distal end; wherein said housing is configured to removably couple to a portable camera proximate said housing proximal end; wherein said camera comprises a camera lens with a camera lens optical axis; and wherein upon coupling of said housing and said camera, said magnifying lens disposes along said camera lens optical axis.

111. The method of claim 110, further comprising providing one or more additional elements disclosed in claims 2-109.1133P01T112. A method of using an eye imaging system, comprising: obtaining said eye imaging system comprising: a magnifying lens housed within a housing having a housing proximal end and an opposing housing distal end; a light source housed within said housing; and a subject interface coupled to said housing proximate said housing distal end; wherein said housing is configured to removably couple to a portable camera proximate said housing proximal end; wherein said camera comprises a camera lens with a camera lens optical axis; and wherein upon coupling of said housing and said camera, said magnifying lens disposes along said camera lens optical axis; and capturing an image of an eye with said camera.

113. The method of claim 112, wherein said image is of an anterior segment of said eye.

114. The method of claim 112, further comprising engaging said eye with said subject interface.

115. The method of claim 114, further comprising properly positioning said eye within said subject interface.

116. The method of claim 112, further comprising adjusting illumination of said eye.

117. The method of claim 112, further comprising adjusting magnification of said eye.

118. The method of claim 112, further comprising optimizing visibility of a cornea of said eye.

119. The method of claim 112, further comprising optimizing visibility of an iris of said eye.

120. The method of claim 112, further comprising optimizing visibility of a sclera of said eye.

121. The method of claim 112, further comprising optimizing visibility of a lens plane of said eye.

122. The method of claim 112, further comprising analyzing said image.1133P01T123. The method of claim 122, further comprising identifying an ocular condition of said eye.

124. The method of claim 123, further comprising referring a subject for examination based upon said ocular condition.

125. The method of claim 123, further comprising referring a subject for treatment based upon said ocular condition.

126. The method of claim 123, wherein said ocular condition comprises an anterior segment condition.

127. The method of claim 126, wherein said anterior segment condition comprises one or more of cataracts (such as nuclear cataracts, cortical cataracts, and posterior subcapsular cataracts), eye lens status (such as clear lens, pseudophakia, aphakia, and posterior capsular opacification), corneal disorders (such as corneal opacity, corneal scarring, pseudophakic bullous keratopathy, band keratopathy, corneal dystrophy or degeneration, trauma, corneal abrasions, corneal lacerations, laceration, presence of foreign bodies, and infectious keratitis (such as fungal, viral, bacterial, and parasitic infections)), glaucoma, ocular inflammatory disorders (such as iritis and uveitis), conjunctivitis, pterygium, ocular surface lesions, ocular surface diseases, inflammatory conditions of the sclera (such as scleritis and episcleritis), anterior segment ischemia, endothelial cell disorders (including Fuchs’ dystrophy), keratoconus, dry eye syndrome, orbital disorders (such as thyroid eye disease and orbital inflammation), eyelid edema, infections, tumors, trauma, ptosis, ocular and eyelid bums, eyelid disorders (such as blepharitis, Meibomian gland dysfunction, chalazia, hordeolum, benign eyelid lesions, and malignant eyelid lesions), and mechanical disorders (such as trichiasis, entropion, ectropion, and palsy).

128. The method of claim 126, further comprising assessing progression of said anterior segment condition.

129. The method of claim 126, further comprising monitoring an outcome of intervention for said anterior segment condition.

130. The method of claim 112, further comprising using said eye imaging system in a clinical setting.1133P01T131. The method of claim 112, further comprising using said eye imaging system in a non- clinical setting.

132. The method of claim 126, wherein said anterior segment condition is in an animal, a human, a donor eye, or a donor tissue.

133. The method of claim 112, further comprising using one or more additional elements disclosed in claims 2-109.

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