Illuminated contact lenses and systems for improved ocular diagnosis, disease management, and surgery

Abstract

A new contact lens is designed to increase the amount of light reaching the retina. The edge of the contact lens is beveled to redirect and increase the light reaching the retina. A light source surrounds and contacts the straight or curved beveled edge. Additionally, a reflective cylinder and its top wall surround the lens to block any light loss. The edge of this far end of the contact lens can 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 next to the low light camera, a short cylindrical housing, a space between the camera assembly and the housing, an internal program in the server to detect good or bad image quality, and an alarm for poor image quality, wherein an operator recaptures the image.

Description

Technical Field

[0001] Embodiments of the illuminated contact lens assembly are directed to a lens assembly for use with an eye 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] Visual impairment can affect one’s ability to survive and quality of life by causing loss of functions such as the ability to read, use a computer, walk, socialize, and operate a vehicle. Typically, an ophthalmologist diagnoses the cause of blindness after a primary health care practitioner refers a patient with complaints of vision problems and loss of function (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 avoid these developments is critical. Included in the list of retinal diseases is damage from diabetes and / or hypertension, as well as age-related macular degeneration (AMD), which is 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 disease will experience vision loss.

[0003] The macula is a small part of the retina at the back of the eye that is essential 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, weak blood vessels under the retina can bleed and cause inflammation and scarring in the retina.

[0005] About 80% of AMD cases are the "dry" or atrophic form, which is a slow loss of the retinal pigment epithelium and photoreceptors (responsible for vision). Advanced stages are either dry AMD or wet AMD. Because of an aging population, it is estimated that there will be about 288 million cases by 2040.

[0006] Another leading cause of blindness is diabetic retinopathy, which accounts 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 who have had diabetes for 20 years or more will develop diabetic retinopathy. It often has no early warning symptoms. However, retinal imaging can detect early signs such as microaneurysms, retinal haemorrhages and vascular abnormalities (e.g. retinal vein ‘beading’ and other microvascular abnormalities). In the affected eye, varying degrees of vision loss occur due to associated leakage of serous fluid and cholesterol into the retina, a complication known as macular oedema. In advanced stages, abnormal blood vessels grow out of the retina in an irregular pattern, causing bleeding. The scar tissue that accompanies these vessels can lead to retinal detachment, causing irreversible vision loss. All of the above stages can be easily imaged by imaging, and screening for any of these signs in people with diabetes is standard care in the UK. Early screening allows for early treatment and prevents unnecessary advanced stages. Simple interventions such as improving blood sugar control, correcting high blood pressure and controlling cholesterol can help avoid or delay advanced stages of diabetic retinopathy.

[0007] High blood pressure alone can cause hypertensive retinopathy, which initially involves the blood vessels. Arterioles narrow locally or generally. Arterioles may "cut" veins. Later, hemorrhages and "cotton-wool spots" (areas of ischemia) may develop, along with vision loss. Even before blood pressure is significantly elevated, about 3-14% of adults over 40 will develop hypertensive retinopathy. In addition, dozens of other less common disorders may also have ocular manifestations.

[0008] Many patients with hypertension, diabetic retinopathy, AMD, etc., arrive at the retina specialist’s office at an advanced stage. As established by many studies such as the ETDRS (Early Treatment Diabetic Retinopathy Study), DRS (Diabetic Retinopathy Study), and the PANORAMA study, early diagnosis translates into preservation of vision, improved quality of life, reduced burden on health care and disability systems, and increased productivity. With tens of millions of additional AMD patients expected to age in the near future, and a shortage of eye care providers (ophthalmologists and optometrists) as we see inefficiencies in traditional eye exams, there is a critical 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 plane through which the retina can be viewed; c) a partially beveled side of the contact lens, wherein the side has a narrower circumference at the distal surface near the plane and a wider circumference near the proximal curved surface; d) a partially straight side (perpendicular to the plane) of the contact lens extending from the proximal surface to the beveled side.

[0010] Optionally, the contact lens has 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") at 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, the contact lens assembly has: a) a proximal curved surface to contact the surface of the eye; b) a distal plane through which the retina can be viewed; c) a beveled edge where the contact lens has a narrower circumference at the distal surface and a wider circumference near the curved surface; d) a partially straight edge (perpendicular to the plane) of the contact lens extending from the curved surface to the beveled edge; e) a light source surrounding and contacting at least a portion of the beveled side, the light source having a circular 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 0.25mm to 2.75mm. Alternatively, the thickness of the contact lens is about 2.75mm to about 10mm. 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 facing the beveled edge of the reflector and enclosing the light source to prevent excessive light from escaping the contact lens assembly. The eye contact lens assembly may also have a top wall above the cylindrical reflector, the top wall extending from the cylindrical reflector to the side of the eye contact lens. The reflective material of the eye 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 photos from the camera and send them to a selected eye care specialist's mobile device; e) a mobile device that displays photos of the eye, receives swipe messages indicating the state of the eye, and receives commands from the eye care specialist; f) a server that converts the eye care specialist's commands into communications with health care professionals and patients; g) a server programmed to pay the eye care specialist; h) a server programmed to send the processed photos to the eye care specialist.

[0014] Optionally, the mobile device displays symbols for a swipe gesture, information, and a lock, whereby a swipe, click, or other gesture sends a signal that the photo is normal. When opened, the lock holds the same photo to zoom in or move back and forth. The mobile device includes but is not limited to a smart phone, 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, the eye imaging camera includes a low light camera assembly with a microcomputer, a photo sensor next 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 photo sensor.

[0016] The above and other aspects, features, and advantages will be apparent to one of ordinary skill 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 on the eye and a known camera next to the lens;

[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 ocular 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 top view schematic diagram of an ocular contact lens assembly having a chamfered 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 chamfered edge;

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

[0026] Fig. 9 is a cross-sectional schematic diagram of an ocular contact lens assembly showing a cylindrical reflector having a top wall surrounding all chamfered portions of the ocular contact lens;

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

[0028] Fig.11 Shows Fig.10 Schematic diagram of the path of a single ray of light in the model;

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

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

[0031] Fig.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 the two retinas. Figure 15-1 The retina labeled as disease-free is shown. Figure 15-2 A retina labeled as having a diseased condition is shown; and

[0033] Fig.16 The next screen in the app is shown, where the eye specialist 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 health care professionals. We also described an improved eye imaging camera, also designed for ease of use by health care professionals. We further linked the acquisition of photos to a system for certified eye care professionals (described below). While these three parts work together to produce a new paradigm in health care, each can be used in conjunction with other medical devices or systems that have the potential to improve patient outcomes. Each of these parts is described below.

[0036] New contact lens with integrated light source

[0037] 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 illumination 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.

[0038] 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's lens. Even with the use of AR coatings, reflections from the cornea still present challenges for clearly viewing the interior of the eye. Many fundus camera designs spatially separate the illumination optical path and the imaging path. This design results in a smaller clear aperture for imaging, which limits image quality.

[0039] 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 to enter through the planar lens 2 and reach 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 anti-reflection coating, stray light 12 will 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 further explained below.

[0040] Reference Figure 2 , shows a currently used planar lens 14. This particular lens is manufactured by the Netherlands Ophthalmic 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 refractive power of the human eye. The planar lens can provide a clear view of the intraocular space of the eye. Figure 3 , shows a cross-sectional view of the current flat 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 lens is flat on the surface 18 facing away from the human eye. Inside the lens, the proximal curvature 20 of the lens is visible. The shape of the curvature is adapted to the human 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.

[0041] Without being bound by any one theory, various embodiments of the planar lens assembly described herein may operate based on total internal reflection (TIR). TIR is a phenomenon that reflects all incident light away from the boundaries of a surface. TIR only occurs when two conditions are met: light approaches a less dense medium in a denser 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 reflects between air and water, the large angle of incidence can be any angle greater than 48°. For other media or materials, the angle can be determined using the formula θ=arcsin(n2 / n1), where n1 is the refractive index of the denser medium and n2 is the refractive index of the less dense medium.

[0042] Embodiments of contact lens assemblies as 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 can increase the field of view of the lens to the limit of the pupil and can avoid geometric interference with other devices. Finally, various embodiments of the contact lens assembly eliminate most stray light because little 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.

[0043] Reference Figure 4, shows an embodiment of a cross-sectional view of a contact lens 22 with a bevel cut. A rounded bevel is cut from the top corner of the contact lens. The bevel cut can be straight or can 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 by a laser, diamond, blade, or other method of cutting glass to provide a clean cut. In other embodiments, the contact lens can be formed with a beveled edge by 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 about 90°. In various embodiments, depending on the material of the contact lens, the maximum feasible 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. The contact lens may be thicker (2.75 mm to about 5 or 10 mm) in new applications.

[0044] 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 perimeter 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 may include a fiber optic ring. The surface of the fiber optic ring is unshaped to provide a random position of the light. The placement of the light source 28 reduces stray light because the light beam is not as Figure 1 In other embodiments, light does not directly reach the outer surface of the contact lens from the outside of the contact lens as shown in the prior art models in FIG. Instead, light directly contacts the lens surface from the inside and then reflects back to illuminate the retina according to the TIR principle. In other embodiments, a light emitting diode (LED) lamp is used as the light source. The LED light source provides discrete points of light.

[0045] 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 chamfered edge of the contact lens. As shown, the light source 36 is configured to be coupled to an external light source through an additional optical fiber 37. The distal top 38 and proximal bottom 40 edges of the chamfered edge are shown by two concentric circles. Figure 7 , a cross-sectional schematic diagram of a contact lens assembly 42 having a light source 44 coupled to a chamfered edge 46 is shown.

[0046] Reference Figure 8, shows an embodiment of a contact lens assembly 48 including 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 facing 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 in its cavity.

[0047] refer to Fig. 9 , showing Figure 8 Schematic diagram of a cross-section of a contact lens assembly. In this view, the side walls 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 58 of the reflector 54 to better retain light for eye photos.

[0048] Reference Fig.10 , shows a total internal reflection (TIR) ​​model when using an embodiment of a contact lens assembly 60. A contact lens 62 is shown coupled to a spherical surface 64 similar to a 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 front face of the contact lens. As previously described, there is an upper limit angle of 180-2*arcsin(1 / n) for the bevel cut. Any angle less than this angle can 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.

[0049] Reference Fig.11 , shows a schematic diagram of the model. The schematic diagram shows a single beam of light 74 from a light source 76 and reflected from the inner surface of a contact lens 78. TIR may cause all light to be reflected from the inner surface or distal interface of the contact lens. Fig.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. Fig.13 , the graph illustrates the relatively uniform illumination of the retina using an embodiment of a planar lens assembly as described herein.

[0050] Although the precursors of 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.

[0051] The components for illuminating contact lens assemblies can be made of conventional materials used to manufacture commercial products similar to these products in the art, such as, as non-limiting examples, glass, polymers, poly(methyl methacrylate), silicone, plastics, optical fibers, reflective materials, and LEDs. One of ordinary skill in the art will be able to readily select suitable materials from the disclosure provided herein and manufacture these products.

[0052] Eye Imaging Camera

[0053] We invented a new eye imaging camera that is better suited for use by frontline health care professionals and shares data with eye care specialists.

[0054] A short cylindrical housing, mimicking a short pen for easy storage, is currently preferred. Preferably, a light sensor and lens are provided at the end of a low lens camera subassembly, with a spacer between the housing and the camera subassembly. Preferably, the eye imaging camera records multiple photos and even video, which can provide more insight into the patient's current retinal status, as well as the status of other ocular structures imaged with our camera.

[0055] There are increasingly more sensitive and smaller cameras available, and our innovative eye imaging cameras will take advantage of these improvements. In addition, these cameras are increasingly effective in low light conditions and will produce better pictures of the eye than before. These factors combine to produce better quality images, whether the patient is providing an unstable gaze or is very young.

[0056] The eye imaging camera is digital to facilitate transfer of images to a computer for 1) magnification, 2) professional analysis, 3) addition to patient files for comparison, etc. The eye imaging camera has a server that can optionally be programmed to detect whether the captured image has met the quality standards required by the eye care professional and / or diagnostic algorithm 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 health care provider by light or sound within minutes (preferably seconds) 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 health care professional.

[0057] 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.

[0058] The eye imaging camera of the present invention preferably has a housing that can withstand shock from accidental drops and from uncooperative patients in a variety of clinic and emergency situations. The more compact the eye imaging camera, the easier it is for health care professionals and paraprofessionals to use; this increases usability in a wider range of environments from clinics to disaster areas.

[0059] Portable eye imaging cameras can optionally provide good illumination for a detailed view of the retina. Currently, it is best to equip them with light emitting diode (LED) lights, which have the advantages of high brightness and low heat generation. The LED lights can be configured in a variety of ways, including but not limited to a) one or more pin lights, b) a row of LED lights and / or c) a circle of LED lights within the lens portion of our design.

[0060] 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.

[0061] system

[0062] As mentioned above, there will be tens of millions of patients with AMD in the coming years—far more than the current and future number of eye care providers who can adequately diagnose and screen with traditional eye exams. After careful consideration, we invented a method to create a more efficient way to connect primary practitioners and eye care specialists for early diagnosis. This approach enables retina specialists, ophthalmologists, optometrists (eye care specialists) to diagnose hundreds of patients per hour.

[0063] Illuminated contact lenses are placed on the patient's eyes, and each receives a retinal photograph. Optionally, the exterior and anterior segment 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. (eye specialist). The program identifies and arranges the photographs appropriately.

[0064] 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 rapid diagnosis ( Fig.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 ten 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 should be understood that the actual time varies depending on the complexity of the pathology, the eye care specialist's experience with the system, etc.

[0065] 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 advisory to the patient and / or referring physician, recommending a follow-up visit.

[0066] In one embodiment, there are three options at the bottom of each image: 1) a side-swipe mark to expedite reporting of absence of symptoms and return diagnosis, 2) an informational image, and 3) a lock mechanism that allows viewing of more data. The lock holds the current image and enables the specialist to zoom in on the image (by pinching fingers on the screen or other convenient method to zoom). Enlarging a specific area can improve the observation of the condition. The image can also be swept directionally 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 eye imaging areas. 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.

[0067] FIG15 shows normal and abnormal images.

[0068] Fig.16 A screen is shown to confirm the diagnosis with a "yes" or "no" button. After 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.

[0069] In another embodiment, retinal images of the left and right eyes of the same patient are displayed together on one screen.

[0070] The system automatically generates and forwards reports to the designated patient, primary care provider, and / or other designated parties to notify them of the diagnosis. The system is highly secure and complies with laws governing patient privacy.

[0071] Three service tiers are envisioned for the system, although fewer or more are possible. Specific activities can be assigned to different tiers.

[0072] The first tier is a screening level where photos are reported as either very normal or abnormal. This is a simple and effective way to triage and save visits to the doctor's office. The first tier is also suitable for health optimization protocols because it monitors eye health well before an individual notices vision loss. Abnormal blood vessels can be one of the signs of developing hypertensive or diabetic retinopathy.

[0073] The second layer provides the information of the first layer and more information, such as the diagnosis of the disease condition.

[0074] The third level provides the information from the second level and more, such as the degree of disease and other expert comments and insights. This level can include the extent of damage detected. For diabetic retinopathy, experts assign descriptions of mild, moderate, and severe nonproliferative and proliferative retinopathy; for hypertensive retinopathy, a standardized grade is assigned.

[0075] The third layer is also suitable for monitoring the progression of ocular pathologies.Preferably, a previous picture is compared with a current picture, for example by overlaying the previous image and the current image.

[0076] Activity in the third layer may also be useful for tracking the progression of other chronic diseases (i.e. diabetes and hypertension) since blood vessels can only be examined in the retina.

[0077] When the server generates the report, it pays the specialist via any electronic banking app and loads the next set of retinal images.

[0078] The present invention has important benefits not only for patients, but also for physicians and the care system. The advantage to the patient is that this remote "first visit" by an eye specialist can be done much earlier in the pathology, thus enabling effective preventive measures, e.g., lifestyle changes, early retinal interventions, etc. In addition, the patient avoids the inconvenience and cost of eye specialist visits, transportation, and lost income. In addition, the patient and physician can view all histories of their retinal images on our secure portal for educational and patient progress monitoring purposes.

[0079] Since diagnosis using our system takes only a fraction of the specialist’s time, the cost is a fraction of a traditional eye exam. Additionally, since 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 an eye care professional is able to perform more exams without the expense of office and staff expenses, he or she can save a significant amount of money. The eye care professional’s time and office can then be used for those cases that truly require a traditional office visit.

[0080] The benefit to the health care system is that “first visits” can be done 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.”

[0081] Example 1

[0082] As described above, an eye care professional using our system remotely can typically effectively evaluate retinal photographs and make a gesture swipe or click diagnosis in less than ten seconds, especially for normal photographs. Photos that are significantly abnormal may also take less than 10 seconds, quickly marked by swiping or clicking, and then quickly classified again by swiping or clicking. These correspond to the first and second layers described above. If an eye care professional can perform one (or so pairs) of retinal assessments every 10 seconds on average, this means 6 patients / pairs of eyes per minute and 360 people per hour. Assuming two hours of rest time and 6 hours of active work time per day and 5 days of assessment per week, it is conceivable that each eye care professional could evaluate 10,800 patients per week, or approximately 540,000 patients per year, at a fraction of the cost of traditional examinations. A busy eye care professional might perform traditional eye examinations on 50 patients per day in regular practice, which would be 12,500 patient visits per year. Many of these traditional visits are also 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.

[0083] Example 2

[0084] Busy eye care professionals don’t need to spend their entire day on our system. Instead, a few hours per day are enough to make a noticeable difference—from patient to 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 eye care professional per year.

[0085] In another embodiment, after the images pass a quality control image check (see Ocular Imaging Camera description) and are uploaded and transmitted, a diagnostic algorithm helps diagnose diabetic and hypertensive retinopathy and annotates 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 vary less in appearance; therefore, the AI ​​can diagnose "healthy" more accurately. As we build our image database, the AI ​​will develop to the point where it can diagnose all images and assess the extent of diabetic and hypertensive retinopathy. We will compare the human assessments 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.

[0086] Other options in the system include returning more detailed data to the data repository and sharing it in greater detail with local physicians.

[0087] 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, as non-limiting examples, smart phones, tablets and virtual reality devices. Those of ordinary skill in the art will be able to easily select suitable materials from the disclosure provided herein and manufacture these products.

[0088] Many other diseases and syndromes also affect the retina and can be effectively assessed by 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 diseases, 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, environmental or toxic conditions that may be associated with ocular findings. The embodiments listed here, as well as many others, will become apparent from the present disclosure. Thus, one of ordinary skill in the art will readily appreciate the versatility of the application of the present disclosure.

[0089] In the United States alone, the pet market is worth tens of millions. Working animals (e.g., dairy cows) are numerous. Both types of animals require inexpensive care. The disclosed contact lenses, eye imaging cameras, and systems can be easily adapted for both the pet and working animal markets.

[0090] 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 from the foregoing description. It is therefore intended to embrace all such changes, modifications and variations in the appended claims.

[0091] The foregoing description is only regarded as an explanation of the principle of the present invention. In addition, since it is easy for those skilled in the art to think of many modifications and variations, it is not desirable to limit the present invention to the exact product and process shown and described above. Therefore, all suitable modifications and equivalents may be adopted and fall within the scope of the present invention.

[0092] In order to promote the understanding of the principles of the present invention, the above detailed description and examples represent only exemplary embodiments, and are intended to be described using specific language. However, it should be understood that it 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 will be appreciated by those skilled in the relevant art and who possess this disclosure, are considered to be within the scope of the present invention.

[0093] References throughout the specification to "embodiment," "example," or similar language mean 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, the appearance of the phrases "embodiment" and "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, the words "embodiment," "example," etc., referring to two or more features, elements, etc., do not mean that these features are necessarily related, different, the same, etc.

[0094] Although similar or identical language is used to characterize each embodiment, each statement of an embodiment or example is 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 the like described herein are considered capable of being combined with one another, directly or indirectly, implicitly or explicitly, in whole or in part, as directed by the claims and / or the art.

[0095] As used herein, "comprising," "including," "containing," "being," "characterized by," and their grammatical equivalents are inclusive or open-ended terms that do not exclude other unrecited elements or method steps. "Comprising" should be interpreted broadly and include the more restrictive terms "consisting of" and "consisting essentially of."

[0096] References to features, advantages, or similar language throughout the specification do not imply that all features and advantages that can be achieved by the present invention are or should be in any single embodiment of the present invention. Rather, language referring to features and advantages is understood to mean that a particular feature, advantage, or characteristic described in conjunction with an embodiment is included in at least one embodiment of the present invention. Therefore, discussion of features and advantages and similar language throughout this specification may, but do not necessarily, refer to the same embodiment.

[0097] In addition, in one or more embodiments, the features, advantages and characteristics of the present invention may be combined in any suitable manner. Those skilled in the relevant art will recognize that the present invention may be practiced without one or more specific features or advantages of a particular embodiment. In other cases, additional features and advantages may be considered 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 plane on a second side opposite to 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 closer to the curved surface and a narrower circumference closer to the flat surface; and A straight edge between the curved surface and the one or more chamfered edges is oriented perpendicular to the plane, wherein, during use, the contact lens is not fixedly coupled to an eye imaging camera.

2. The contact lens according to claim 1, wherein: The ocular contact lens comprises at least one of glass, polymer, polymethylmethacrylate, coating, silicone and plastic.

3. The contact lens according to claim 1, wherein: The one or more chamfered edges may be at 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 planes are rounded to expand the field of view through the lens and allow a wider angle of the retina to be captured.

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

7. The contact lens according to claim 1, wherein: The thickness between the curved surface and the flat surface is 0.25 mm to 2.75 mm.

8. The contact lens according to claim 1, wherein: The one or more beveled edges may be straight or curved.

9. The contact lens according to claim 1, wherein: The thickness between the curved surface and the flat surface is 2.75 mm to 10 mm.

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