Illuminated contact lens and system for improved ocular diagnosis, disease management, and surgery

Abstract

Illuminated contact lenses and systems for improving ocular diagnostics, disease management and procedures are aimed at increasing the amount of light reaching the retina. The edge of the contact lens is beveled to redirect and increase light reaching the retina. The light source surrounds and contacts the straight or curved beveled edge. In addition, a reflective cylinder and its top wall surround the lens to block any light loss. The edge of this distal end of the contact lens may be rounded to increase the angle at which the retina is visible. A new eye imaging camera has a low light camera assembly with a server, a light sensor alongside the low light camera, a short cylindrical housing, a space between the camera assembly and the housing, an internal procedure in the server for detecting good or bad image quality, and an alarm of poor image quality in which an operator recaptures the image.

Description

This application is a divisional application of the following application: International application number of the original application: PCT / US2019 / 056148 International filing date of the original application: October 14, 2019 National application number of the original application: 201980082016.2 Title of the original application: Illuminated contact lenses and systems for improving ocular diagnosis, disease management, and surgery Technical Field

[0001] Embodiments of the illuminated contact lens assembly are directed to lens assemblies for use with an ocular imaging camera. Specific embodiments also include a reflector and a light source to illuminate the anterior and posterior segments of a patient's eye. These devices are used in rapid diagnostic systems. Background Art

[0002] Vision impairment can lead to loss of functions such as the ability to read, use a computer, walk, socialize, and operate a vehicle, impacting one's ability to survive and quality of life. Typically, an ophthalmologist diagnoses the cause of blindness after a primary care practitioner refers a patient with complaints of vision problems and functional impairment (e.g., difficulty reading or driving). Worldwide, the World Health Organization reports that the most common cause of blindness is cataracts, followed by age-related macular degeneration and diabetic retinopathy. Most severe vision loss occurs in people over the age of 50. Therefore, early diagnosis to prevent these developments is crucial. The list of retinal diseases includes damage from diabetes and / or hypertension, as well as age-related macular degeneration (AMD), the leading cause of blindness in the United States and other industrialized countries. It is the leading cause of vision loss in people over the age of 50. By the age of 80, most people with this condition will have experienced vision loss.

[0003] The macula is a small part of the retina at the back of the eye that is crucial for high-acuity vision. When a person turns their head to focus on an object, the macula converges on that object. When the macula is damaged, only peripheral vision is preserved, while central vision is lost.

[0004] High blood pressure and diabetes can damage small blood vessels, including those in the retina. In people with diabetes, if left untreated, the weak blood vessels under the retina can bleed and cause inflammation and scarring in the retina.

[0005] Approximately 80% of AMD cases are the "dry" or atrophic form, which slowly causes the loss of the retinal pigment epithelium and photoreceptors (responsible for vision). Advanced forms of AMD are either dry or wet. Due to an aging population, it is estimated that there will be approximately 288 million cases by 2040.

[0006] Another leading cause of blindness is diabetic retinopathy, accounting for 12% of all new cases of blindness. Importantly, it is the leading cause of blindness in people aged 20-64 years. 80% of patients with diabetes for 20 years or longer will develop diabetic retinopathy. It often has no early warning symptoms. However, retinal imaging can detect early signs such as microaneurysms, retinal hemorrhages, and vascular abnormalities (e.g., retinal vein "beading" and other microvascular abnormalities). Eyes affected by the associated leakage of serous fluid and cholesterol into the retina can experience varying degrees of vision loss, a complication known as macular edema. In advanced stages, abnormal blood vessels grow out of the retina in irregular patterns, causing hemorrhages. The scar tissue associated with these vessels can lead to retinal detachment, causing irreversible vision loss. All of these stages can be easily imaged with imaging, and screening for any of these signs in diabetic patients is standard care in the UK. Early screening allows for early treatment and prevents unnecessary advanced disease. Simple interventions such as improving blood sugar control, correcting high blood pressure, and controlling cholesterol can help avoid or delay the advanced stages of diabetic retinopathy.

[0007] High blood pressure alone can cause hypertensive retinopathy, which initially involves blood vessels. Arterioles narrow locally or globally. Arterioles may "cut" veins. Bleeding and "cotton-wool spots" (areas of ischemia) may follow, along with vision loss. Even before blood pressure rises significantly, approximately 3–14% of adults over 40 develop hypertensive retinopathy. Dozens of other less common conditions can also have ocular manifestations.

[0008] Many patients with conditions like hypertension, diabetic retinopathy, and AMD arrive at their retina specialist's office at an advanced stage. As established by numerous studies, including the ETDRS (Early Treatment Diabetic Retinopathy Study), DRS (Diabetic Retinopathy Study), and PANORAMA, early diagnosis translates into preserved vision, improved quality of life, reduced burden on healthcare and disability systems, and increased productivity. With tens of millions of additional AMD patients expected to age in the near future, and with the inefficiencies seen in traditional eye exams and a shortage of eye care providers (ophthalmologists and optometrists), there is a pressing need to increase capacity and efficiency. Summary of the Invention

[0009] In one embodiment, a contact lens is disclosed that includes: a) a proximal curved surface to contact the surface of the eye; b) a distal planar surface through which the retina is viewed; c) a partially beveled side of the contact lens, wherein the side has a narrower circumference near the distal surface of the planar surface and a wider circumference near the proximal curved surface; d) a partially straight side (perpendicular to the planar surface) of the contact lens extending from the proximal surface to the beveled side.

[0010] Optionally, the contact lens comprises at least one of glass, polymer, polymethyl methacrylate and plastic. The angle of the beveled edge of the contact lens is about 0° to about 90°. The beveled edge can be straight or curved. Preferably, the angle of the beveled edge is about 45°. Optionally, the slightly flat surface ("flat") of the distal end can be slightly rounded to expand the field of view through the contact lens and capture a wider angle of the retina. The maximum feasible angle of the contact lens material is determined by Θ<180-2*arcsin(1 / n), where n is the refractive index of the material. The thickness of the contact lens is about 0.25 mm to 2.75 mm. Alternatively, the thickness of the contact lens is about 2.75 mm to about 10 mm.

[0011] In another embodiment, an eye contact lens assembly has: a) a proximal curved surface to contact the surface of the eye; b) a distal planar surface through which the retina is viewed; c) a beveled edge where the contact lens has a narrower circumference at the distal surface and a wider circumference proximal to the curved surface; d) a partially straight side (perpendicular to the planar surface) of the eye contact lens extending from the curved surface to the beveled edge; and e) a light source surrounding and contacting at least a portion of the beveled side, the light source having an annular cross-section.

[0012] Optionally, the angle of the beveled contact lens edge of the contact lens assembly is about 0° to about 90°. The angle of the beveled contact lens can be about 45°. The distal contact lens surface of the contact lens assembly can be slightly rounded to expand the field of view through the contact lens and capture a wider angle of the retina. The maximum feasible angle of the material is determined by Θ<180-2*arcsin(1 / n), where n is the refractive index of the material. The thickness of the contact lens can be in the range of about 0.25 mm to 2.75 mm. Alternatively, the thickness of the contact lens is about 2.75 mm to about 10 mm. The beveled edge can be straight or concave. The contact lens assembly includes at least one of glass, polymer, polymethyl methacrylate, plastic, optical fiber, reflective material and LED. The contact lens assembly can also have a cylindrical reflector with a beveled edge facing the reflector and enclosing the light source, thereby preventing excessive light from escaping the contact lens assembly. The contact lens assembly may further comprise a top wall above the cylindrical reflector, the top wall extending from the cylindrical reflector to the side of the contact lens.The reflective material of the contact lens assembly may be a mirror or a coated surface.

[0013] In yet another embodiment, an improved system for screening and diagnosing eyes of a large number of patients is disclosed, the system comprising: a) a contact lens for contacting the eye; b) a light source; c) a camera placed on the contact lens and connected to a server; d) a server programmed to receive and process a photo from the camera and send it to a mobile device of a selected eye care professional; e) a mobile device that displays a photo of the eye, receives a swipe message indicating the state of the eye, and receives commands from the eye care professional; f) a server that converts the eye care professional's commands into communications with health care professionals and patients; g) a server programmed to pay the eye care professional's fees; and h) a server programmed to send the processed photo to the eye care professional.

[0014] Optionally, the mobile device displays a symbol for a swipe gesture, a message, and a lock, thereby signaling that the photo is normal by a swipe, click, or other gesture. When opened, the lock retains the same photo for zooming in or moving back and forth. The mobile device includes but is not limited to a smartphone, a tablet computer, and a virtual reality device. The screening system may have a program for pre-classifying photos into normal and abnormal. The contact lens may have a beveled edge with a light source positioned thereon. The contact lens may have a beveled edge, a light source, and a reflective cylinder having a top wall extending to the edge of the contact lens.

[0015] In yet another embodiment, an eye-imaging camera includes a low-light camera assembly having a microcomputer, a photosensor adjacent to the low-light camera, a short cylindrical housing, a space between the camera assembly and the housing, a light on the front of the housing, an internal program in the microcomputer for detecting good or bad image quality, and an alarm for poor image quality. Optionally, the low-light camera assembly includes a light and a photosensor.

[0016] The foregoing and other aspects, features, and advantages will be apparent to those skilled in the art from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Embodiments will be described below with reference to the accompanying drawings, wherein like reference numerals denote like elements, and:

[0018] Figure 1 is a schematic cross-sectional view of an eye with a typical flat contact lens and a known camera adjacent thereto;

[0019] Figure 2 is a schematic diagram of currently commercially available contact lenses;

[0020] Figure 3 is a schematic cross-sectional view of an existing plane lens;

[0021] Figure 4 is a schematic cross-sectional view of an embodiment of a beveled ophthalmic contact lens;

[0022] Figure 5 is a schematic side view of an ocular contact lens assembly having a light source thereon;

[0023] Figure 6 is a schematic top view of an ophthalmic contact lens assembly having a beveled edge and a light source;

[0024] Figure 7 is a schematic cross-sectional view of an ocular contact lens assembly with a light source coupled to a beveled edge;

[0025] Figure 8 is a view of an ocular contact lens assembly having a cylindrical reflector coupled to a contact lens edge;

[0026] Figure 9 is a schematic cross-sectional view of an ophthalmic contact lens assembly showing a cylindrical reflector having a top wall surrounding all beveled portions of the ophthalmic contact lens;

[0027] Figure 10 is a schematic diagram of the total internal reflection (TIR) model applied to contact lenses;

[0028] Figure 11 Shown Figure 10 Schematic diagram of the path of a single ray of light in the model;

[0029] Figure 12 is another representation of the model, with the small contact eye on the left and the large retina on the right;

[0030] Figure 13 A graph showing relatively uniform retinal illumination;

[0031] Figure 14 is a diagram of a retina photo with controls at the bottom of the screen;

[0032] Figure 15 shows side-by-side photographs of two retinas. Figure 15-1 The retina labeled as non-diseased is shown. Figure 15-2 shows a retina labeled as having a diseased condition; and

[0033] Figure 16 The next screen in the app is shown, where the eye care professional must confirm the previous decision. DETAILED DESCRIPTION

[0034] After much thought and experimentation, we devised a method to create a more efficient way to connect primary practitioners and eye care specialists for early eye diagnosis. This method enables retina specialists, ophthalmologists, optometrists, etc. (eye care specialists) to diagnose and triage hundreds of patients per hour.

[0035] First, we invented a special lighted contact lens designed to make lens placement and imaging simpler and more effective for frontline healthcare professionals. We also described an improved ocular imaging camera, also designed for ease of use by healthcare professionals. We further linked the acquisition of images to a system for certified eye care professionals (described below). While these three components simultaneously create a new paradigm in healthcare, each component can be used in conjunction with other medical devices or systems that have the potential to improve patient outcomes. Each of these components is described below. New contact lens with integrated light source

[0036] Adequate illumination is an essential component of ophthalmology and a challenge because various parts of the eye, including the pigment epithelium or inner surface of the mammalian eye, have very low reflectivity. Any stray light reflected from the interface between the air and the most distal phase of the vitreous humor can significantly distort the view of the intraocular space. These lighting challenges affect ocular imaging and intraocular surgery. For example, during intraocular surgery, one or more intraocular lighting probes are inserted into the sclera (the protective outer layer of the eye) to deliver light directly to the retina to increase visibility within the eye. These light probes are expensive and require invasive access to the eye.

[0037] In retinal imaging, a specialized low-power microscope with an attached camera is used to image the inner surface of the eye (i.e., the fundus), including the retina, retinal vasculature, optic disc, and macula. Current retinal imaging technology involves the use of anti-reflective (AR) coatings on the glass used for the camera lens. Even with AR coatings, reflections from the cornea still pose challenges for clearly viewing the interior of the eye. Many fundus camera designs spatially separate the illumination and imaging paths. This design results in a smaller aperture for imaging, which limits image quality.

[0038] Reference Figure 1 , shows a schematic diagram of a currently used planar lens 2 with a fundus camera. The desired path for light 6 is through the planar lens 2 and into the back of the eye. Light from a light source below the camera is directed into a beam splitter 8 and then reflected into the eye 10. However, as shown by the green line, even with an antireflection coating, stray light 12 can reflect from the surface of the planar lens. Stray light 12 can also reflect from the inner curve of the planar lens, as will be explained further below.

[0039] Reference Figure 2 , shows a currently used planar lens 14. This particular lens is manufactured by the Netherlands Eye Research Center (DORC) BV, a limited liability company in Zuidland, the Netherlands. The planar lens is an optical element applied to the cornea to offset most of the human eye's refractive power. The planar lens provides a clear view of the intraocular space of the eye. Figure 3 , shows a cross-sectional view of the current planar lens 16. This particular lens has a diameter of 12 mm. Referring again to FIG. Figure 2 As shown, when the lens is on the eye, the surface 18 of the lens facing away from the eye is flat. Inside the lens, the proximal curvature 20 of the lens is visible. This curvature is shaped to the eye to provide optimal imaging of the retina and fundus. The many surfaces and curves of the lens increase the amount of stray light generated.

[0040] Without being bound by any one theory, the various embodiments of the planar lens assemblies described herein may operate based on total internal reflection (TIR). TIR is a phenomenon where all incident light is reflected away from a surface boundary. TIR only occurs when two conditions are met: light is moving from a denser medium toward a less dense medium, and the angle of incidence is greater than the so-called critical angle. Total internal reflection only occurs at large angles of incidence. For example, when light is reflected between air and water, the large angle of incidence can be any angle greater than 48°. For other media or materials, the formula θ can be used. =arcsin(n2 / n1) determines the angle, where n1 is the refractive index of the denser medium and n2 is the refractive index of the less dense medium.

[0041] Embodiments of the contact lens assembly described herein are designed to improve retinal imaging and intraocular surgery by optimizing the delivery of light to the retina in a non-invasive and non-traumatic manner. In various embodiments of the contact lens assembly, there are no components in front of the lens and near the eye. This increases the field of view of the lens to the limit of the pupil and avoids geometric interference with other devices. Finally, various embodiments of the contact lens assembly eliminate most stray light because less light escapes from the distal surface of the planar lens before being reflected back to the retina. We design contact lenses to transmit more light and reduce light scatter.

[0042] Reference Figure 4, shows an embodiment of a cross-sectional view of a contact lens 22 having a bevel cut. A circular bevel is cut from the top corner of the contact lens. The bevel cut can be straight or produce a curved edge (concave or convex). In various embodiments, the bevel 24 can be cut from a standard contact lens. In some embodiments, the contact lens can be cut using a laser, diamond, blade, or other glass cutting method to provide a clean cut. In other embodiments, the contact lens can be formed with a beveled edge using molding or other techniques. The contact lens is cut at an angle θ of 45°. In other embodiments, the angle can range from 0° to approximately 90°. In various embodiments, depending on the material of the contact lens, the maximum possible angle can be determined using the formula θ<180-2*arcsin(1 / n), where n is the refractive index of the material. In various embodiments, the thickness of the contact lens can range from 0.25 mm to 2.75 mm. Contact lenses in new applications may be thicker (2.75 mm to approximately 5 or 10 mm).

[0043] Reference Figure 5 , shows a side view of an embodiment of a contact lens assembly 26. In this embodiment, the planar lens assembly 26 includes a light source 28. The light source is shown coupled around the periphery of a chamfered edge 30 of a contact lens 32. A planar lens 32 is shown. As shown, the light source 28 has an annular shape. The annular shape of the light source 28 provides a continuous light source. In various embodiments, the light source 28 can include a fiber optic ring. The surface of the fiber optic ring is unshaped to provide a random position of light. The placement of the light source 28 reduces stray light because the light beam is not as Figure 1 In one embodiment, light does not directly strike the outer surface of the contact lens from the outside of the contact lens, as shown in the prior art models. Instead, light directly strikes the lens surface from the inside and then reflects back to illuminate the retina based on the TIR principle. In other embodiments, a light emitting diode (LED) lamp is used as the light source. The LED light source provides a discrete point of light.

[0044] Reference Figure 6 , shows a top view of an embodiment of a contact lens assembly 34. A light source 36 is shown, which is located on the beveled edge of the contact lens. As shown, the light source 36 is configured to be coupled to an external light source via an additional optical fiber 37. The distal top 38 and proximal bottom 40 edges of the beveled edge are shown by two concentric circles. Figure 7 , shows a schematic cross-sectional view of a contact lens assembly 42 having a light source 44 coupled to a chamfered edge 46.

[0045] Reference Figure 8, shows an embodiment of a contact lens assembly 48 that includes a contact lens 50, a light source 52, and a reflector 54. The reflector is coupled to the contact lens on a straight edge near the chamfered edge. In various embodiments, the reflector 54 can be formed of a reflector material, wherein the reflector faces the light source. In other embodiments, the first surface of the reflector 54 that faces the chamfered edge of the contact lens has a reflective surface. The reflector includes a reflective material or has a coated surface or reflective material coupled to the inside of the reflector. The outside of the chamfered edge can also be coated. The reflector 54 surrounds the light source to form a cavity having a circular shape around the chamfered edge of the planar lens assembly and the light source. The reflector helps to retain more reflected light within its cavity.

[0046] refer to Figure 9 , showing Figure 8 FIG2 is a schematic cross-sectional view of a contact lens assembly of FIG2. In this view, the sidewalls 58 and top wall 56 of the reflector 54 are shown. As shown, the light source 52 is completely enclosed within the top wall 56 and side walls 58 of the reflector 54 to better retain light for eye photographs.

[0047] Reference Figure 10 , shows a total internal reflection (TIR) model when using an embodiment of a contact lens assembly 60. The contact lens 62 is shown coupled to a spherical surface 64 similar to the human eye. A light source 66 is shown coupled around the beveled edge of the contact lens 62. A reflector 68 is shown coupled to the flat edge of the contact lens. In this particular view, the side walls of the reflector are not shown to increase the visibility of the reflection of light ray 70 within the reflector chamber. Light ray 70 is shown as a thin, scattered line throughout the model. Total internal reflection causes essentially all light to be reflected back when it first reaches the distal interface of the contact lens 62, including the transparent central portion on the flat surface of the contact lens. As previously mentioned, there is an upper limit angle of 180-2*arcsin(1 / n) for the bevel cut. Any angle less than this angle will eliminate stray light. The optimal angle depends on the contact lens material / light source angle profile. Due to the reflective surface of the reflector, all light should also be reflected back from the reflector.

[0048] Reference Figure 11 , shows a schematic diagram of the model. The schematic diagram shows a single light ray 74 from a light source 76 and reflected from the inner surface of a contact lens 78. TIR may cause all light rays to be reflected from the inner surface or distal interface of the contact lens. Figure 12 When TIR is achieved using an embodiment of a contact lens assembly 80 as described herein, the retina and other structures within the posterior interior surface of the eye 82 are well illuminated. Figure 13 , a graph illustrating relatively uniform illumination of the retina using an embodiment of a planar lens assembly as described herein.

[0049] Although the precursors to the contact lenses of the present invention have been described as "flat" lenses, it may be beneficial to provide a slight curvature on the distal surface of our contact lenses. Such a curvature provides a wider field of view of the interior space of the eye.

[0050] The components for the illuminated contact lens assembly can be made of conventional materials used to manufacture commercial products similar to these in the art, such as, by way of non-limiting example, glass, polymers, poly(methyl methacrylate), silicone, plastics, optical fibers, reflective materials, and LEDs. One of ordinary skill in the art will readily be able to select appropriate materials from the disclosure provided herein and manufacture these products. Eye imaging camera

[0051] We invented a new eye imaging camera that is more suitable for use by frontline healthcare professionals and shares data with eye care specialists.

[0052] Currently preferred is a short cylindrical housing, mimicking a short pen for easier storage. Preferably, the light sensor and lens are located at the end of a low-lens camera subassembly, with a spacer between the housing and the camera subassembly. Preferably, the ocular imaging camera records multiple photos and even video, providing a deeper understanding of the patient's current retinal status, as well as the status of other ocular structures imaged by our camera.

[0053] Increasingly sensitive and smaller cameras are becoming available, and our innovative eye-imaging cameras will take advantage of these improvements. Furthermore, these cameras are becoming increasingly effective in low-light conditions and produce better pictures of the eye than ever before. These factors combine to produce better-quality images, regardless of whether the patient's gaze is unstable or they are very young.

[0054] The ocular imaging camera is digital to facilitate transfer of images to a computer for 1) magnification, 2) specialized analysis, 3) addition to the patient's file for comparison, etc. The ocular imaging camera has a server that can optionally be programmed to detect whether the captured image has met the quality standards required by eye care professionals and / or diagnostic algorithms to diagnose diabetic retinopathy and other retinal diseases. The algorithm is designed to run quickly and efficiently on the camera or in the cloud to alert the healthcare provider within minutes (preferably seconds) by light or sound if the image quality is poor and the image needs to be recaptured. Preferably, the images are recaptured during the same visit and only high-quality images are analyzed. Real-time feedback of the captured images will increase the value and confidence of the healthcare professional.

[0055] The digital eye imaging camera preferably has WIFI capability to minimize weight.The eye imaging camera of the present invention preferably has batteries for ease of use without wires getting in the way.

[0056] The ocular imaging camera of the present invention preferably has a housing that can withstand the impact of accidental drops and uncooperative patients in various clinic and emergency situations. The more compact the ocular imaging camera, the easier it is for healthcare professionals and paraprofessionals to use; this increases its usability in a wider range of environments, from clinics to disaster zones.

[0057] Portable eye-imaging cameras can optionally provide good illumination for detailed views of the retina. Currently, light-emitting diode (LED) lighting is preferred, as these offer the advantages of high brightness and low heat generation. LED lighting can be configured in a variety of ways, including but not limited to a) one or more pinhole lamps, b) an array of LEDs, and / or c) a ring of LEDs within the lens portion of our design.

[0058] The LED light is designed to have sufficient power to provide adequate illumination of the retina, particularly the macula, which is only about 5.5 mm in diameter. system

[0059] As mentioned above, there will be tens of millions of people living with AMD in the coming years—far more than the current and future number of eye care providers who can adequately diagnose and screen for the disease through traditional eye exams. After careful consideration, we devised a method to create a more efficient way to connect primary care practitioners with eye care specialists for early diagnosis. This approach enables retinal specialists, ophthalmologists, and optometrists (eye care specialists) to diagnose hundreds of patients per hour.

[0060] Illuminated contact lenses are placed in the patient's eyes, and each receives a retinal photograph. Optionally, the outer and anterior segments of the eye are also photographed. External photographs will help account for quality limitations due to eyelid abnormalities or anterior segment opacities. The photographs and accompanying patient information are transmitted to a central server and then to the mobile device of a selected retinal analyst, including but not limited to a retinal specialist, ophthalmologist, optometrist, etc. (ophthalmologist). The program identifies and arranges the photographs appropriately.

[0061] Eye care specialists are selected based on their ability to differentiate between normal and abnormal retinas. The eye care specialist logs into the system. The mobile application (app) opens and automatically loads the retinal image for a quick diagnosis ( Figure 14). Preferably, the images are displayed as left and right images of the patient. Preferably, the first pair of images are of the outside of the eye. If these are normal, the specialist swipes left to view the internal images. The eye care specialist can quickly review these; most cases are normal and the specialist signals the server with a swipe gesture to send a letter to the patient and / or referring physician indicating that there are no serious abnormalities. It is expected that these steps will take the eye care specialist less than 10 seconds. Preferably, the analysis time ranges from one to thirty seconds, more preferably three to twenty seconds and most preferably eight to ten seconds. It will be understood that actual times will vary depending on the complexity of the pathology, the eye care specialist's experience with the system, etc.

[0062] When the specialist observes that an eye requires a follow-up visit, a swipe gesture forwards this decision to the server, which in turn sends a letter recommendation to the patient and / or referring physician, recommending a follow-up visit.

[0063] In one embodiment, at the bottom of each image are three options: 1) a side-swipe marker to expedite reporting of absence of symptoms and return for diagnosis, 2) an informational image, and 3) a lock mechanism that allows viewing of more data. The lock maintains the current image and enables the specialist to zoom in on the image (by pinching fingers together on the screen or other convenient method). Enlarging a specific area can improve the observation of the condition. The image can also be directionally swept to pan more of the retinal surface, allowing the specialist to access all magnified areas of the photo to analyze the overall health of the eye and locate problems in all areas of the eye imaged. Optionally, the eye care specialist can expand the image by double-swiping or double-clicking or dragging a portion of the image with two fingers.

[0064] FIG15 shows normal and abnormal images.

[0065] Figure 16 A screen is shown with a "yes" or "no" button to confirm the diagnosis. Following this screen, the specialist may choose to enter other relevant clinical information, including but not limited to age, degree of diabetic or hypertensive retinopathy, etc.

[0066] In another embodiment, retinal images of the left and right eyes of the same patient are displayed together on one screen.

[0067] The system automatically generates and forwards reports to designated patients, primary care providers, and / or other designated parties to inform them of the diagnosis. The system is highly secure and complies with laws governing patient privacy.

[0068] Three service layers are envisioned for the system, although fewer or more are possible. Specific activities can be assigned to different layers.

[0069] The first level is a screening level where photos are reported as either perfectly normal or abnormal. This is a simple and effective classification method that can save visits to the doctor's office. This level is also suitable for health optimization protocols because it can monitor eye health well before individuals notice vision loss. Abnormal blood vessels can be a sign of developing hypertensive or diabetic retinopathy.

[0070] The second layer provides the information of the first layer and more information, such as the diagnosis of the disease condition.

[0071] The third level provides the information from the second level and further information, such as the degree of disease and other expert comments and insights. This level may include the extent of damage detected. For diabetic retinopathy, experts assign mild, moderate, and severe nonproliferative and proliferative retinopathy descriptions; for hypertensive retinopathy, a standardized grade is assigned.

[0072] The third layer is also suitable for monitoring the progression of ocular pathologies.Preferably, a previous picture is compared with the current picture, for example by overlaying the previous image and the current image.

[0073] Activity in this third layer could also be used to track the progression of other chronic diseases (i.e., diabetes and hypertension), since blood vessels can only be examined in the retina.

[0074] When the server generates the report, it pays the specialist via any e-banking app and loads the next set of retinal images.

[0075] This invention offers significant benefits not only to patients but also to physicians and the care system. The advantage for patients is that this remote "first consultation" by an ophthalmologist can be completed much earlier in the pathology, enabling effective preventative measures such as lifestyle changes and early retinal intervention. Furthermore, patients avoid the inconvenience and costs of ophthalmologist visits, transportation, and lost income. Furthermore, patients and physicians can access their entire history of retinal images on our secure portal for educational and patient progress monitoring purposes.

[0076] Because diagnosis using our system takes only a fraction of a specialist's time, the cost is a fraction of a traditional eye exam. Furthermore, because diagnosis can be performed via mobile devices, including but not limited to tablets, smartphones, and virtual reality devices, eye care professionals can conduct "screening visits" anytime, anywhere. When eye care professionals are able to perform more exams without the expense of an office and staff, they save significant money. The eye care professional's time and office space can then be used for those conditions that truly require a traditional office visit.

[0077] The benefit to the healthcare system is that “first visits” can be performed quickly and cost-effectively. As mentioned above, traditional office visits for general eye care specialists and retina specialists will become more streamlined and “high-yield.” Example 1

[0078] As described above, an eye care professional using our system remotely can typically effectively evaluate retinal photographs and make a swipe or click diagnosis in less than ten seconds, particularly for normal photographs. Significantly abnormal photographs may also require less than 10 seconds, quickly marked with a swipe or click, and then quickly classified again with a swipe or click. These correspond to the first and second layers described above. If an eye care professional can perform one (or approximately one pair of) retinal assessments every 10 seconds on average, this translates to six patients / pairs of eyes per minute and 360 patients per hour. Assuming a two-hour break and six hours of active work time per day, and five days of assessment per week, each eye care professional could conceivably evaluate 10,800 patients per week, or approximately 540,000 patients per year, at a fraction of the cost of traditional exams. A busy eye care professional might perform a traditional eye exam on 50 patients per day in their regular practice, resulting in 12,500 patient visits per year. Many of these traditional visits are repeat visits, further highlighting the efficiency of our proposed system. If AI eliminates normal eyes from the pool of eyes to be evaluated, experts can read most of the pathologies and efficiency will be further improved. Example 2

[0079] Busy eye care professionals don't need to spend their entire day using our system. Instead, a few hours per day are enough to make a significant difference—patient by patient and during off-hours. If each eye care professional analyzes retinal photographs for 2 hours per week (720), that's 3,600 times per week, and 3 hours per weekend (1,080), that's 2,160 times per weekend, for a total of 288,000 patients evaluated per year per eye care professional.

[0080] In another embodiment, after the images pass a quality control image check (see ocular imaging camera description) and are uploaded and transmitted, diagnostic algorithms help diagnose diabetic and hypertensive retinopathy and annotate specific retinal features that suggest the diagnosis. Initially, we first use AI to classify images of healthy retinas as a pre-processing step before human readers. This is logical because healthy eyes have less variation in appearance; therefore, the AI can diagnose "healthy" more accurately. As we build our image database, the AI will advance to the point where it can diagnose all images and assess the extent of diabetic and hypertensive retinopathy. We will compare the human evaluations to the AI diagnoses to maintain quality control. Our system is not only an AI product, but also includes human verification at various stages of development.

[0081] Other options within the system include returning more detailed data to the data repository and sharing it in greater detail with local physicians.

[0082] The phones, tablets, virtual devices, and other computerized devices used in the present invention can be conventional models for operating applications similar to those in the art, such as, for example, smartphones, tablets, and virtual reality devices, as non-limiting examples. One of ordinary skill in the art will readily be able to select appropriate materials from the disclosure provided herein and manufacture such products.

[0083] Many other diseases and syndromes also affect the retina and can be effectively assessed using our devices and methods. These include, but are not limited to, the vascular diseases mentioned in the signature, inflammatory diseases, autoimmune diseases that may be associated with ocular findings, ocular tumors, glaucoma and other optic nerve abnormalities, corneal diseases, uveal diseases, lens and related zonular organ diseases, maculopathy, peripheral retinal degeneration, hereditary and congenital diseases that may be associated with ocular findings, infectious processes that may be associated with ocular findings, retinopathy of prematurity, neurological diseases that may manifest as ocular findings, retinal tears, retinal detachments, phakoma, and other systemic diseases associated with ocular findings, autoimmune diseases that may be associated with ocular findings, metabolic diseases that may be associated with ocular findings, degenerative diseases that may be associated with ocular findings, and environmental or toxic conditions that may be associated with ocular findings. The embodiments listed here, as well as many others, will become apparent from this disclosure. Thus, one of ordinary skill in the art will readily appreciate the versatility of the application of this disclosure.

[0084] In the United States alone, the pet market is worth tens of millions. Working animals (e.g., dairy cows) are also numerous. Both types of animals require affordable care. The disclosed contact lenses, eye imaging cameras, and systems can be readily adapted for both the pet and working animal markets.

[0085] While the invention has been described in conjunction with specific embodiments, it is evident that many changes, modifications and variations will be apparent to those skilled in the art in light of the foregoing description. It is therefore intended to embrace all such changes, modifications and variations in the appended claims.

[0086] The foregoing description is merely intended to illustrate the principles of the present invention. Furthermore, since many modifications and variations will readily occur to those skilled in the art, it is not desirable to limit the present invention to the precise products and processes shown and described above. Therefore, all suitable modifications and equivalents may be employed and fall within the scope of the present invention.

[0087] To facilitate understanding of the principles of the present invention, the above detailed description and examples represent exemplary embodiments only and are intended to be described using specific language. However, it should be understood that this is not intended to limit the scope of the present invention. Any changes and further modifications to the inventive features shown herein, as well as any additional applications of the principles of the present invention as shown herein, that would occur to those skilled in the relevant art and possessing this disclosure, are considered to be within the scope of the present invention.

[0088] Reference throughout this specification to "an embodiment," "an example," or similar language means that a particular feature, structure, characteristic, or combination thereof described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "an embodiment" and "an example," and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment, different embodiments, or one or more figures. Furthermore, reference to two or more features, elements, or the like by the words "an embodiment," "an example," or the like does not imply that these features are necessarily related, different, or the same.

[0089] Although similar or identical language is used to characterize each embodiment, each statement of an embodiment or example is to be considered independent of any other statement of an embodiment. Thus, where an embodiment is identified as "another embodiment," the identified embodiment is independent of any other embodiment characterized by the language "another embodiment." The features, functions, and similar features described herein are considered capable of being combined, directly or indirectly, implicitly or explicitly, in whole or in part, with one another as taught by the claims and / or the art.

[0090] As used herein, "comprising," "including," "containing," "is," "characterized by," and grammatical equivalents thereof are inclusive or open-ended terms that do not exclude additional unrecited elements or method steps. "Comprising" is to be construed broadly and encompasses the more restrictive terms "consisting of" and "consisting essentially of.

[0091] Reference throughout this specification to features, advantages, or similar language does not imply that all features and advantages that can be achieved with the present invention are or should be included in any single embodiment of the present invention. Rather, language referring to features and advantages is understood to mean that a specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, discussion of features and advantages, and similar language throughout this specification, may, but do not necessarily, refer to the same embodiment.

[0092] Furthermore, the features, advantages, and characteristics of the present invention may be combined in any suitable manner in one or more embodiments. Those skilled in the relevant art will recognize that the present invention may be practiced without one or more of the specific features or advantages of a particular embodiment. In other cases, additional features and advantages may be recognized as certain embodiments that may not be present in all embodiments of the present invention.

Claims

1. An eye contact lens, characterized in that: include: a curved surface on the first side; a planar surface on a second side opposite the first side; one or more chamfered edges between the first side and the second side, wherein the one or more chamfered edges have a wider circumference proximate the curved surface and a narrower circumference proximate the flat surface; a straight edge perpendicular to the plane between the curved surface and the one or more chamfered edges; as well as A light source completely surrounds and contacts the one or more chamfered edges.

2. The contact lens according to claim 1, wherein The light source has a circular cross-section.

3. The contact lens according to claim 1, wherein The one or more chamfered edges have an angle of 0° to 90° relative to the plane.

4. The contact lens according to claim 1, wherein The one or more chamfered edges have an angle of 45° relative to the plane.

5. The contact lens according to claim 1, wherein The plane is slightly rounded to expand the field of view through the lens and capture a wider angle of the retina.

6. The contact lens according to claim 1, wherein The maximum possible angle Θ of the one or more chamfered edges composed of contact lens material relative to the plane is determined by Θ<180-2*arcsin(1 / n), where n is the refractive index of the contact lens material.

7. The contact lens according to claim 1, wherein Also included is a cylindrical reflector facing the one or more chamfered edges and surrounding the light source.

8. The contact lens according to claim 1, wherein The light source includes one or more light emitting diodes.

9. The contact lens according to claim 1, wherein Also included is a reflector comprising a top wall coupled to a side surface, wherein the top wall contacts the plane and the side surface is coupled to the straight edge.

10. An eye contact lens, characterized in that: include: a curved surface on the first side; a planar surface on a second side opposite the first side; one or more chamfered edges between the first side and the second side, wherein the one or more chamfered edges have a wider circumference proximate the curved surface and a narrower circumference proximate the flat surface; a straight edge perpendicular to the plane between the curved surface and the one or more beveled edges of the contact lens; a light source contacting at least a portion of the one or more chamfered edges; and During use, the contact lens is not fixedly coupled to the eye-imaging camera.

11. The contact lens according to claim 10, wherein The light source has a circular cross-section.

12. The contact lens according to claim 10, wherein Also included is a cylindrical reflector facing the one or more chamfered edges and surrounding the light source.

13. The contact lens according to claim 10, wherein The light source includes one or more light emitting diodes.

14. The contact lens according to claim 10, wherein Also included is a reflector comprising a top wall coupled to a side surface, wherein the top wall contacts the plane and the side surface is coupled to the straight edge.

15. The contact lens according to claim 10, wherein The plane is slightly rounded to expand the field of view through the lens and capture a wider angle of the retina.

16. The contact lens according to claim 10, wherein The one or more chamfered edges have an angle of 0° to 90° relative to the plane.

17. The contact lens according to claim 10, wherein The one or more chamfered edges have an angle of 45° relative to the plane.

18. An eye contact lens, characterized in that include: a curved surface on the first side; a planar surface on a second side opposite the first side; one or more beveled edges located within the material thickness of the ophthalmic contact lens between the first side and the second side, wherein the one or more beveled edges have an angle θ relative to the plane; a straight edge perpendicular to the plane between the curved surface and the one or more chamfered edges; as well as A light source surrounding the entire plane.

19. The contact lens according to claim 18, wherein The maximum possible angle Θ of the one or more chamfered edges composed of contact lens material relative to the plane is determined by Θ<180-2*arcsin(1 / n), where n is the refractive index of the contact lens material.

20. The contact lens according to claim 18, wherein Also included is a cylindrical reflector facing the one or more chamfered edges and surrounding the light source.

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