Irradiation-type contact lenses and improved systems for ophthalmic diagnosis, disease management, and surgery.

Abstract

To provide a more efficient method to lead to early eye diagnosis.SOLUTION: A new ocular contact lens has been designed to increase the amount of light reaching the retina. The contact lens edge is chamfered to redirect and increase the light reaching the retina. Additionally, a reflective cylinder and its top wall encircle the lens to block any loss of light. A new ocular imaging camera has a low-light camera subassembly with server, a photosensor next to the low-light camera, a short cylindrical housing, a space between the camera subassembly and the housing to detect good or poor image quality. The system receives and processes the photographs. The photographs are transmitted to eye care specialists' smart phone, tablet or virtual reality device for evaluation. As specified, the eye care specialist separates normal from abnormal, diagnoses the abnormality, and may even provide detailed information, such as the grade of the abnormality.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] It relates to an implementation form of an irradiation type contact lens assembly for use with an eye imaging camera. Certain implementation forms also include a reflector and a light source to illuminate the front and rear parts of a patient's eye. These devices are used in rapid diagnosis systems.

Background Art

[0002] Visual impairment affects the ability to maintain livelihoods and quality of life through reduced reading ability, computer operation, walking, social life, and vehicle operation. Conventionally, the causes of blindness have been diagnosed by ophthalmologists after primary healthcare providers examined patients who complained of vision problems or reduced functions such as difficulty reading or driving. Worldwide, the most common cause of blindness is cataract, followed by age-related macular degeneration and diabetic retinopathy, as reported by the World Health Organization. Severe visual impairment occurs most frequently in people over 50 years old. Therefore, early diagnosis is important to avoid these progressions. The list of retinal diseases includes diabetic and / or hypertensive damage and age-related macular degeneration (AMD), which is the main cause of blindness in the United States and other developed countries. This is the main cause of visual impairment in people over 50 years old. Most people with this disease experience some visual impairment by the age of 80.

[0003] The macula is a small part of the retina located behind the eye and is extremely important for high vision. When a person turns their head to focus on an object, the macula is positioned at the center with respect to the object. When the macula is damaged, only the surrounding visual field remains and the central vision decreases.

[0004] High blood pressure and diabetes damage thin blood vessels, including those in the retina. In diabetes, fragile blood vessels cause retinal hemorrhage, and if not treated promptly, retinal inflammation and scarring are caused.

[0005] Approximately 80% of AMD cases are "dry" or atrophic, characterized by gradual loss of the retinal pigment epithelium and photoreceptor cells (responsible for vision). The terminal stage is either end-stage dry AMD or end-stage exudative AMD. Due to the aging population, approximately 288 million cases are projected by 2040.

[0006] Another major 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 to 64. Diabetic retinopathy is expected to develop in 80% of people who have had diabetes for more than 20 years. While there are often no early warning symptoms, retinal photography can detect early stages such as vascular abnormalities like microaneurysms, retinal hemorrhages, and "beaded dilations" of retinal veins, as well as other microvascular abnormalities. Related to this, a complication known as macular edema, in which serous fluid and cholesterol leak into the retina, can occur, resulting in varying degrees of vision loss. In the late stages, abnormal blood vessels grow uncontrollably from the retina, leading to bleeding. Scar tissue associated with these vessels can lead to irreversible vision loss due to retinal detachment. All of the above stages can be easily imaged. In the UK, screening for all of these signs is standard practice for people with diabetes. Early screening allows for early treatment and prevents unnecessary progression of the disease. Simple therapeutic interventions such as improved glucose control, correction of hypertension, and cholesterol control can help prevent or slow the progression of diabetic retinopathy.

[0007] Hypertension alone can lead to hypertensive retinopathy, which involves blood vessels from the early stages. Tiny arterioles narrow locally or generally. "Stenosis" of veins due to arterioles can occur. Subsequently, bleeding and "cotton ball" patches (ischemic areas) may occur, leading to decreased vision. Even before blood pressure rises significantly, hypertensive retinopathy is seen in approximately 3% to 14% of adults over 40 years of age. In addition, eye symptoms can also occur due to many other rare diseases.

[0008] Many patients with advanced hypertension, diabetic retinopathy, AMD, etc., visit the clinics of retinal specialists. As established in numerous studies such as the ETDRS (Early Treatment Study of Diabetic Retinopathy), DRS (Diabetic Retinopathy Study), and PANORAMA study, early diagnosis leads to the preservation of vision, improved quality of life, reduced burden on healthcare and disability systems, and increased productivity. With tens of millions more AMD patients expected to age in the near future, a shortage of eye care providers (ophthalmologists and optometrists) is anticipated due to the inefficiencies of conventional eye examinations that we have acknowledged, making increased capacity and efficiency urgently needed. [Overview of the project]

[0009] In one embodiment, an ophthalmic contact lens is disclosed, comprising: a) a proximal curved surface that contacts the surface of the eye; b) a distal flat surface through which the retina can be seen; c) a partially beveled side surface of the ophthalmic contact lens having a circumference that is smaller closer to the flat distal surface and larger closer to the proximal curved surface; and d) a partially straight side surface of the ophthalmic lens (perpendicular to the flat surface) extending from the proximal surface to the beveled side surface.

[0010] Optionally, ophthalmic contact lenses have at least one of glass, polymer, poly(methyl) methacrylate, and plastic. Ophthalmic contact lenses have a beveled edge angle with an angle of about 0° to about 90°. The beveled edge may be straight or curved. Preferably, the beveled edge angle is about 45°. Alternatively, the distal, somewhat flat surface ("flat surface") may be slightly rounded to widen the field of view through the contact lens and capture the retina at a larger angle. The maximum achievable angle of the ophthalmic contact lens material is determined by θ < 180 - 2 * arcsine(1 / n), where n is the refractive index of the material. The thickness of the ophthalmic contact lens is about 0.25 mm to 2.75 mm. Alternatively, the thickness of the ophthalmic contact lens is about 2.75 mm to about 10 mm.

[0011] In other embodiments, an ophthalmic contact lens assembly comprises: a) a proximal curved surface that contacts the surface of the eye; b) a distal flat surface through which the retina can be seen; c) a chamfered edge of the contact lens having a circumference that is smaller closer to the distal surface and larger closer to the curved surface; d) a partially straight edge of the ophthalmic contact lens (perpendicular to the flat surface) extending from the curved surface to the chamfered edge; and e) a light source having an annular cross-section located around and in contact with at least a portion of the chamfered side.

[0012] Optionally, the ophthalmic contact lens assembly has a chamfered contact lens edge angle of approximately 0° to approximately 90°. The chamfered contact lens angle may be approximately 45°. The distal contact lens surface of the ophthalmic contact lens assembly may be slightly rounded to widen the field of view through the contact lens and capture the retina at a larger angle. The maximum achievable angle of the material is determined by θ < 180 - 2 * arcsine(1 / n), where n is the refractive index of the material. The thickness of the ophthalmic contact lens may vary from approximately 0.25 mm to 2.75 mm, or the thickness of the ophthalmic contact lens may be approximately 2.75 mm to approximately 10 mm. The chamfered edge may be straight or concave. The ophthalmic contact lens assembly includes at least one of glass, polymer, poly(methyl) methacrylate, plastic, optical fiber, reflective material, and LED. The ophthalmic contact lens assembly may also have a cylindrical reflector facing the beveled edge of the contact lens and surrounding the light source to prevent more light from leaking out of the ophthalmic contact lens assembly. The ophthalmic contact lens assembly may also have an upper wall portion on the cylindrical reflector that extends from the cylindrical reflector to the side of the ophthalmic contact lens. The reflective material of the ophthalmic contact lens assembly may be a mirror or a coated surface.

[0013] In yet another embodiment, an improved system for examining and diagnosing a large number of patients' eyes is disclosed, comprising: a) an ophthalmic contact lens that contacts the eye; b) a light source; c) a camera positioned on the ophthalmic contact lens and connected to a server; d) a server programmed to receive and process photographs from the camera and transmit the photographs to a portable device of a selected ophthalmic therapist; e) a portable device that displays photographs of the eye, receives swipe messages indicating the condition of the eye, and receives instructions from an eye specialist; f) the server connects the instructions from the eye specialist to communication with medical professionals and optionally the patient; g) the server is programmed to make payments to the ophthalmic therapist; and h) the server is programmed to transmit the processed photographs to the ophthalmic therapist.

[0014] Optionally, the mobile device displays a swipe gesture, information, and lock symbol, which transmit a signal that the photograph is normal via a swipe, tap, or other gesture. When the lock is activated, the same photograph is maintained for zooming in and moving forward and backward. The mobile device includes, but is not limited to, smartphones, tablets, and virtual reality devices. The examination system may have a program to pre-sort photographs into normal and abnormal. The ophthalmic contact lens may have a beveled edge on which a light source is positioned. The ophthalmic contact lens may have a beveled edge, a light source, and a reflective cylinder including an upper wall extending to the edge of the ophthalmic contact lens.

[0015] In yet another embodiment, the eye imaging camera includes a low-light camera subassembly including a minicomputer, a light sensor adjacent to the low-light camera, a short cylindrical housing, a space between the camera subassembly and the housing, illumination in front of the housing, an internal program of the minicomputer for detecting high or low image quality, and an alarm for low image quality. Optionally, the low-light camera subassembly includes illumination and a light sensor.

[0016] Those described above, as well as other aspects, characteristics, and advantages, will become apparent to those skilled in the art through the specification, drawings, and claims.

[0017] The implementation details will be described below in reference to the attached diagrams, in which similar elements are indicated by similar specifications. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 is a schematic cross-section of an eye with a typical flat ophthalmic contact lens in place and a known camera next to it. [Figure 2] Figure 2 provides a general overview of ophthalmic lenses currently on the market. [Figure 3] Figure 3 shows a schematic cross-section of a current flat lens. [Figure 4] Figure 4 shows a schematic cross-section of one example of a chamfered ophthalmic contact lens. [Figure 5] Figure 5-1 is a schematic side view of an ophthalmic contact lens assembly with a light source mounted on it. [Figure 6] Figure 6 is a schematic top view of a contact lens assembly showing the chamfered edge and light source. [Figure 7] Figure 7 shows a schematic cross-section of a contact lens assembly with a light source connected to a chamfered edge. [Figure 8] Figure 8 shows an ophthalmic contact lens assembly in which a cylindrical reflector is connected to the edge of the contact lens. [Figure 9] Figure 9 is a schematic cross-sectional view of a contact lens assembly, showing a cylindrical reflector whose upper wall surrounds the entire beveled portion of the contact lens. [Figure 10] Figure 10 shows an overview of the TIR model applied to ophthalmic contact lenses. [Figure 11] Figure 11 is an overview of the model in Figure 10, showing the optical path of a single beam of light. [Figure 12]FIG. 12 is another depiction of the model, showing the contact lens small on the left side and the retina large on the right side. [Figure 13] FIG. 13 is a graph showing relatively uniform retinal irradiation. [Figure 14] FIG. 14 is an overview of a photograph of the retina, including a control unit at the bottom of the screen. [Figure 15-1] FIG. 15-1 shows photographs of two adjacent retinas, showing the retina classified as having no lesions. [Figure 15-2] FIG. 15-2 shows photographs of two adjacent retinas, showing the retina classified as having lesions. [Figure 16] FIG. 16 shows the next screen of the application, where the eye specialist needs to confirm a prior decision.

BEST MODE FOR CARRYING OUT THE INVENTION

[0019] After much consideration and experimentation, we have invented a method for creating a more efficient approach to connect primary care providers and ophthalmic treatment specialists to early eye diagnosis. According to this method, retinal specialists, ophthalmologists, optometrists, etc. (ophthalmic treatment specialists) can diagnose and triage hundreds of patients per hour.

[0020] First, we have invented a special irradiation type contact lens designed to make lens installation and photography by front-line medical specialists simpler and more effective. We also describe an improved eye imaging camera designed to be easier for medical specialists to use. Further, we also associate the acquisition of photographs using a system (described later) by qualified ophthalmic treatment specialists. The three parts are synchronized to create a new paradigm in medicine, and each of these parts can be used with other medical devices or systems that can be expected to improve patient outcomes. The three parts are described below.

[0021] A new contact lens that incorporates a light source. The extremely low reflectivity of various parts of the eye, including the pigment epithelium or inner surface, makes proper illumination a critical and challenging aspect of ophthalmology. Stray light reflected from the interface between air and the most distal phase of the vitreous humor can significantly distort the intraocular space. These illumination challenges affect both ocular imaging and intraocular surgery. For example, in intraocular surgery, one or more intraocular irradiation probes are inserted into the sclera, the protective outer layer of the eye, to deliver light directly to the retina to improve visibility within the eye. These optical probes are expensive and require invasive entry into the eye.

[0022] In retinal imaging, a specialized low-magnification microscope equipped with a camera is designed to image the inner surface of the eye (i.e., the fundus), including the retina, retinal vascular system, optic nerve head, and macula. Current retinal imaging techniques include using anti-reflective (AR) coatings on the lens glass used in the camera. Even with anti-reflective coatings, reflections from the cornea remain a challenge in clearly viewing the inner surface of the eye. In many fundus camera designs, the illumination path and the imaging path are spatially separated. This design narrows the aperture for imaging, limiting image quality.

[0023] Referring to Figure 1, an outline of a flat lens 2 containing a fundus camera currently in use is shown. The desired optical path 6 enters through the flat lens 2 and heads toward the back of the eye. Light from a light source located below the camera is directed into a beam splitter 8 and reflected into the eye 10. However, as shown by the green line, even with the AR coating, stray light 12 bounces off the surface of the flat lens. Also, stray light 12 can bounce off the inward curvature of the flat lens, as will be further explained below.

[0024] Referring to Figure 2, we see a flat lens 14 currently in use. This particular lens is manufactured by DORC, a privately held limited liability company in Zeidland, Netherlands. A flat lens is an optical component that is placed on the cornea to neutralize most of the diopter of the human eye. A flat lens allows for a clear view of the intraocular space of the eye. Figure 3 shows a cross-section of a current flat lens 16. This particular lens has a diameter of 12 mm. Referring again to Figure 2, the lens is flat at the surface 18 distal to the human eye when the lens is on the eye. Within the lens, the proximal curvature 20 of the lens is visible. This curvature is shaped to fit the human eye in a way that optimally images the retina and fundus of the eye. Many surfaces and curvatures in the lens can increase the amount of stray light produced.

[0025] Various implementations of flat lens assemblies as described herein may function based on total internal reflection (TIR), without being bound by a single theory. TIR is a phenomenon that includes the reflection of all incident light at the boundary of a surface. TIR occurs only when two conditions are met: the light is in a denser medium and moving toward a less dense medium, and the angle of incidence is greater than the so-called critical angle. Total internal reflection occurs only when the angle of incidence is large. For example, a large angle of incidence may be any angle greater than 48°, the angle at which light reflects between air and water. For other media or materials, the angle may be determined by the formula θ = arcsine(n2 / n1), where n1 is the refractive index of the denser medium and n2 is the refractive index or the less dense medium.

[0026] The contact lens assembly configurations described herein are designed to improve retinal imaging and intraocular surgery through optimized light delivery to the retina using non-invasive and non-traumatic methods. In the various configurations of the contact lens assembly, there are no components anterior to the lens and proximal to the eye. This allows the lens's field of view to extend to the limits of the pupil and avoids geometric interference with other devices. Finally, the various configurations of the contact lens assembly eliminate most stray light, as a small amount of light leaks from the distal surface of the flat lens before reflecting off the retina. We designed the contact lens to deliver more light paths and reduce light scattering.

[0027] Referring to Figure 4, a cross-sectional view of a contact lens 22 having a chamfered cut surface is shown. A circular chamfered surface is cut from the upper corner of the contact lens. The chamfered cut surface may be straight or it may create a curved edge (concave or convex). In various configurations, the chamfered surface 24 may be cut from a standard contact lens. In some configurations, the contact lens may be cut by laser, diamond, blade or other glass cutting method to provide a clean cut. In other configurations, the contact lens may be formed including the chamfered edge by casting or other techniques. The contact lens is cut at an angle θ of 45°. In other configurations, the angle may vary from 0° to approximately 90°. In various configurations, the maximum achievable angle may be determined depending on the material of the contact lens by the formula θ < 180 - 2 * incsine(1 / n), where n is the refractive index of the material. The thickness of the contact lens may vary from 0.25 mm to 2.75 mm in various mounting configurations. For new applications, the contact lens may be thicker (2.75 mm to approximately 5 mm or 10 mm).

[0028] Referring to Figure 5, a side view of a mounting configuration of the contact lens assembly 26 is shown. In this mounting configuration, the flat lens assembly 26 includes a light source 28. The light source is shown connected around the outer circumference of the chamfered edge 30 of the contact lens 32. A flat 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 mounting configurations, the light source 28 may include an optical fiber loop. The surface of the optical fiber loop is deformed to provide a random arrangement of light. By installing the light source 28, stray light is reduced because the beam of light does not directly strike the outer surface of the contact lens from the outside, as shown in the current model in Figure 1. Rather, the light strikes the lens surface directly from the inside according to the TIR principle, reflects, and illuminates the retina. In other mounting configurations, light-emitting diode (LED) light is used as the light source. The LED light source provides discrete points of light.

[0029] Referring to Figure 6, a top view of the mounting configuration of the contact lens assembly 34 is shown. A light source 36 is shown and is positioned on the chamfered edge of the contact lens. The light source 36 is configured to be connected to an external light source through an additional optical fiber 37, as shown. The edges of the chamfered edge, the distal upper 38 and the proximal bottom 40, are shown by two concentric circles. Referring to Figure 7, a schematic cross-section of the contact lens assembly 42 with the light source 44 connected to the chamfered edge 46 is shown.

[0030] Referring to Figure 8, a mounting configuration of a contact lens assembly 48 is shown, which 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 beveled edge. In various mounting configurations, the reflector 54 may be formed of a mirror-finished material with a mirror facing the light source. In other mounting configurations, the first surface of the reflector 54 facing the beveled edge of the contact lens has a reflective surface. The reflector comprises reflective material or has reflective material coupled to a coated surface or the inside of the reflector. The outside of the beveled edge may also be coated. The reflector 54 surrounds the light source by forming a circular chamber around the beveled edge of the flat lens assembly and the light source. The reflector helps to retain more reflected light inside its chamber.

[0031] Referring to Figure 9, an overview of the cross-sectional view of the contact lens assembly in Figure 8 is shown. This drawing shows the side wall 58 and top wall 56 of the reflector 54. As shown, the light source 52 is completely enclosed within the top wall 56 and side wall 58 of the reflector 54 in order to retain more light for the photograph of the eye.

[0032] Referring to Figure 10, a model of total internal reflection (TIR) ​​is shown using the mounting configuration of the contact lens assembly 60. The contact lens 62 is shown connected to a spherical surface 64 similar to that of the human eye. The light source 66 is shown connected around the chamfered edge of the contact lens 62. The reflector 68 is shown connected to the flat edge of the contact lens. In this particular drawing, the side walls of the reflector are not shown to improve the visibility of the reflection of the light ray 70 within the reflector chamber. The light ray 70 is shown throughout the model as a faint, scattered line. In total internal reflection, essentially all light is reflected upon its initial arrival at the distal interface of the contact lens 62, which includes a distinct central portion on the anterior flat surface of the contact lens. As mentioned above, the chamfered cross-section has an upper limit angle of 180 - 2 * inverse sine (1 / n). Any smaller angle can act to eliminate stray light. The optimal angle varies depending on the angle profile of the contact lens material / light source. All light should be reflected by the reflecting surface of the reflector.

[0033] Referring to Figure 11, an overview of the model is shown. The overview shows a single beam of light 74 emitted from a light source 76 and reflected off the inner surface of the contact lens 78. Due to TIR, all the light is reflected off the inner surface or distal interface of the contact lens. Referring to Figure 12, when TIR is achieved using the mounting configuration of the contact lens assembly 80 as described herein, the retina and other structures within the posterior inner surface of the eye 82 are firmly illuminated. Referring to Figure 13, the graph shows relatively constant retinal illumination using the mounting configuration of a flat lens assembly as described herein.

[0034] While the pioneering contact lens inventions describe a "flat" lens, it may be beneficial to incorporate a slight curvature on the distal surface of our contact lenses. This curvature allows for a wider view of the internal space of the eye.

[0035] Components used in irradiation contact lens assemblies may be made from conventional materials used to make similar products to those in the art, including, but not limited to, glass, polymers, poly(methyl methacrylate), silicone, plastics, optical fibers, reflective materials, and LEDs. Those skilled in the art will readily be able to select appropriate materials and manufacture these products based on the disclosures herein.

[0036] Eye imaging camera We have invented a novel eye imaging camera that is better suited for use by frontline medical professionals and for sharing data with ophthalmic specialists.

[0037] The currently preferred design is a short, cylindrical housing that resembles a short pen for easy storage. Preferably, the light sensor and lens are located within the end of the low-lens camera subassembly, with a spacer between the housing and the camera subassembly. Preferably, the eye imaging camera also records multiple photographs and videos that can provide more detailed insights into the current state of the patient's retina and the state of other ocular structures imaged by our camera.

[0038] As more sophisticated and smaller cameras become available, our invention of an eye imaging camera will take advantage of these improvements. Furthermore, these cameras will become increasingly effective in low-light conditions, producing better eye images than previously available. These factors combined will result in higher quality images even when the patient's gaze is unstable or when the patient is very young.

[0039] The eye imaging camera is digital to facilitate the transfer of images to a computer for purposes such as 1) magnification, 2) expert analysis, and 3) adding patient files for comparison. The eye imaging camera has a optionally programmed server to detect whether the captured images meet the quality standards necessary for ophthalmic specialists and / or diagnostic algorithms to diagnose diabetic retinopathy and other retinal diseases. The algorithm is designed to run quickly and efficiently, either on the camera or in the cloud, and to alert healthcare providers with light or sound within minutes (preferably seconds) if the image quality is low or if recapture is required. Preferably, images are recaptured during the same physician's consultation, and only high-quality images are analyzed. Real-time feedback of captured images will increase the value and trust of healthcare professionals.

[0040] The digital eye imaging camera preferably has a WIFI component to minimize weight. The eye imaging camera according to the invention preferably has a battery for convenient use without the need for cumbersome cords.

[0041] The eye imaging camera according to the invention preferably has a housing that can withstand the impact of unexpected drops in various outpatient clinics and emergency situations, or from uncooperative patients. The smaller the eye imaging camera, the more convenient it is for medical professionals and their assistants to use, thereby increasing its potential in a wider range of environments, from outpatient clinics to disaster areas.

[0042] Portable eye imaging cameras optionally provide excellent illumination for detailed viewing of the retina. Currently, it is best to use light-emitting diode (LED) light, which has the advantages of low heat generation and high brightness. LED light can be configured in various forms, including but not limited to a) one or more pinpoint lights, b) a line of LED light, and / or c) an LED light ring within the lens portion of our design.

[0043] The LED light is designed to have sufficient power and aims to provide adequate illumination to the retina, particularly the macula, which has a diameter of only about 5.5 mm.

[0044] system As mentioned above, tens of millions more AMD patients will be born within the next few years, far exceeding the current and future number of ophthalmic care providers capable of accurate diagnosis and examination using conventional eye examinations. After careful consideration, we have invented a more efficient method to connect primary care providers and ophthalmic specialists to early eye diagnosis. This method allows retinal specialists, ophthalmologists, optometrists, etc. (ophthalmic specialists) to diagnose hundreds of patients per hour.

[0045] Irradiation contact lenses are placed on the patient's eye, each receiving a retinal image. Optionally, the external and anterior portions of the eyeball are also photographed. External images will help illustrate quality limitations due to eyelid abnormalities or anterior opacities. The images and accompanying patient information are transmitted to a central server and then supplied to the portable devices of selected retinal analysts, including but not limited to retinal specialists, ophthalmologists, and optometrists (ophthalmic treatment specialists). The images are appropriately identified and arranged through programming.

[0046] Ophthalmic specialists are selected based on their ability to distinguish between abnormal and normal retinas. The ophthalmic specialist signs into the system. A mobile application (app) opens and automatically loads retinal images for rapid diagnosis (Figure 14). The images are preferably displayed as images of the patient's right and left eyes. Preferably, the first pair of images are external images of the eye. If these are normal, the specialist swipes left to view the internal images. The ophthalmic specialist can quickly review these, and if most are normal as indicated by the specialist's swipe gesture, a message is sent to the server indicating that no serious abnormalities were found to the patient and / or the referring physician. These steps are expected to take less than 10 seconds of the ophthalmic specialist's time. Preferably, the analysis time varies from 1 to 30 seconds, more preferably from 3 to 20 seconds, and most preferably from 8 to 10 seconds. It should be understood that the actual time will vary depending on the complexity of the lesion, the ophthalmic specialist's experience using the system, etc.

[0047] If a specialist observes an eye that requires follow-up, they can use a swipe gesture to transfer this decision to the server and send a message to the patient and / or the contracting physician recommending follow-up.

[0048] In one embodiment, each image has three options at the bottom: 1) a side-sweep mark to expedite reporting of lesions or diagnoses without follow-up, 2) an informational image, and 3) a lock mechanism to allow viewing of further data. The lock allows specialists to zoom in on the image (by pinching on the screen or using other convenient methods) while preserving the current image. Zooming in on a specific area improves the visibility of lesions. Images can also be directionally swept to pan over more of the retinal surface, allowing specialists to analyze the overall health of the eye and pinpoint problems across the entire imaging area of ​​the eye by accessing the entire enlarged area of ​​the photograph. Alternatively, ophthalmic specialists can consume images by double-swiping or clicking, or by dragging two fingers to separate parts of the image.

[0049] Figure 15 shows normal and abnormal images.

[0050] Figure 16 shows a screen for confirming the diagnosis using "Yes" or "No" buttons. Following this screen, the specialist can optionally enter other relevant clinical information, including but not limited to age and the degree of diabetic or hypertensive retinopathy.

[0051] In other embodiments, images of the retinas of both eyes of the same patient are displayed together on a single screen.

[0052] The system automatically generates a report and forwards it to one or more designated patients, primary care providers, and / or other designated individuals to notify them of the diagnosis. The system is highly secure and complies with patient privacy laws.

[0053] Three service layers are considered for the system, but fewer or more layers are also possible. Specific activities can be assigned to different layers.

[0054] Triage stage 1 is the screening stage where photographs are reported as normal or abnormal based on macroscopic findings. This is a simple and efficient triage method that reduces the need for examinations in a doctor's office. Triage stage 1 is also suitable for health optimization protocols because it allows individuals to closely monitor their eye health before they notice vision loss. Abnormal blood vessels can be one sign of progressing hypertensive or diabetic retinopathy.

[0055] Layer 2 provides further information, such as the information from Layer 1 and the diagnosis of lesions.

[0056] Layer 3 provides information from Layer 2, as well as additional information such as the extent of the lesion and specialist notes and insights. This level may include the degree of damage detected. For diabetic retinopathy, specialists are assigned descriptions of mild, moderate, and severe non-proliferative and proliferative retinopathy, and for hypertensive retinopathy, a standardized assessment is assigned.

[0057] Layer 3 itself is also useful for observing the progression of eye lesions. Preferably, for example, by overlaying previous images with current images to compare previous images with current images.

[0058] Layer 3 activity can also be used to track the progression of other chronic diseases (i.e., diabetes and hypertension) because blood vessel observation is only possible within the retina.

[0059] While the server is generating the report, it makes a payment to the specialist using any e-banking app and loads the next set of retinal images.

[0060] This invention offers significant advantages not only for patients but also for physicians and the healthcare system. The patient's benefit lies in the fact that remote "initial consultations" by ophthalmologists can be conducted at an earlier stage of disease progression, enabling effective preventative measures such as lifestyle improvements and early retinal treatment intervention. Furthermore, patients avoid the inconvenience and cost of visiting an ophthalmologist, the associated travel, and the resulting loss of income. Additionally, both patients and physicians can view the complete history of their retinal images on our secure web portal for educational purposes and to monitor patient progression.

[0061] Because our system requires only a minimal amount of specialist time for diagnosis, the cost is also a fraction of that of traditional eye examinations. Furthermore, since diagnoses are performed via portable devices, including but not limited to tablets, smartphones, and virtual reality devices, ophthalmologists can conduct "examinations" at their convenience, regardless of location. This represents a significant saving for ophthalmologists, as they can perform more examinations without incurring the overhead costs of a clinic or staff. This also allows ophthalmologists to dedicate their time and clinic resources to cases that truly require a traditional clinic visit.

[0062] The benefit to the healthcare system is that "initial consultations" will be quicker and more cost-effective. Traditional clinic visits to general ophthalmologists and retinal specialists will become more efficient and, as mentioned earlier, will result in a "higher success rate."

[0063] Example 1 As described above, ophthalmic specialists using our system remotely can frequently diagnose retinal images, and diagnoses using gesture-based swiping or tapping are often performed efficiently in less than 10 seconds, especially for normal images. Significantly abnormal images can also be quickly symbolized in less than 10 seconds by swiping or tapping, and then quickly classified again by swiping or tapping. These correspond to layers 1 and 2 above. If an ophthalmic specialist performs one (or more) retinal assessments per 10 seconds on average, this translates to 6 patients / 6 pairs of eyes per minute, or 360 patients / 360 pairs of eyes per hour. Assuming 5 days of assessment per week with a 2-hour break for rest and 6 hours of work time per day, it is estimated that each ophthalmic specialist could assess 10,800 patients per week, or approximately 540,000 patients per year, at a fraction of the cost of conventional examinations. A busy ophthalmologist, with an annual patient count of 12,500, can see 50 patients per day during their regular workday, based on conventional eye examinations in their practice. Many of these conventional visits are follow-ups, further highlighting the efficiency of our proposed system. By using AI to remove normal eyes from the stored image of the eyes being assessed, specialists can focus primarily on identifying lesions, further improving efficiency.

[0064] Example 2 Busy ophthalmologists don't need to dedicate their entire schedules to our system. Instead, even a few hours a day, between patients or during downtime, can make a significant difference. If each ophthalmologist analyzes retinal images for 2 hours per day on weekdays (720 cases) totaling 3,600 cases per week, and 3 hours each day on weekends (1,080 cases) totaling 2,160 cases, then each ophthalmologist would assess a total of 288,000 patients per year.

[0065] In other embodiments, after images pass through quality control image inspection (see description of eye imaging camera), are uploaded and transmitted, a diagnostic algorithm assists in diabetic and hypertensive retinopathy diagnosis, as well as annotating specific retinal characteristics that facilitated the diagnosis. First, we use artificial intelligence as a pre-processing step to select images of healthy retinas before human reading. This is reasonable because healthy eyes have little visual variation, allowing AI to diagnose "health" more accurately. Once we have built an image database, the AI ​​progresses to the point where it diagnoses all images and assesses the degree of diabetic and hypertensive retinopathy. We maintain quality control by comparing human assessment with AI diagnosis. Our system is not only an AI product, but also includes human verification at every stage of its development.

[0066] An additional option within the system is to send more detailed data back to the data storage unit for more detailed sharing with local doctors.

[0067] The telephones, tablets, virtual devices, and other computerized devices used in the present invention may be conventional models used to run applications similar to those in the art, such as smartphones, tablets, and virtual reality devices, but are not limited to these examples. Those skilled in the art will find it readily possible to select appropriate materials and manufacture these products based on the disclosures herein.

[0068] Many other diseases and syndromes affect the retina and can be efficiently assessed by our apparatus and methods. These include, but are not limited to, the aforementioned vascular diseases, inflammatory diseases, autoimmune diseases with possible related ocular findings, neoplastic diseases of the eye, glaucoma and other optic nerve abnormalities, corneal diseases, uveal diseases, diseases of the lens and associated ciliary zonules, maculopathy, peripheral retinal degeneration, hereditary and congenital diseases with possible related ocular findings, infectious processes with possible related ocular findings, retinopathy of prematurity, neurological diseases that may be evident by ophthalmic findings, retinal lacerations, retinal detachment, nevus diseases, and other systemic diseases with possible related ocular findings, autoimmune diseases with possible related ocular findings, metabolic diseases with possible related ocular findings, degenerative diseases with possible related ocular findings, and environmental or toxic symptoms with possible related ocular findings. The implementations listed herein and many other implementations will be readily apparent from this disclosure. This will make it easy for those skilled in the art to understand the versatility to which this disclosure applies.

[0069] The pet market alone comprises tens of millions of animals in the United States. There are also a large number of livestock, such as dairy cows. Affordable treatment is needed for both types of animals. The disclosed contact lenses, eye imaging cameras, and systems can be easily applied to the pet and livestock markets.

[0070] Although the present invention has been described in relation to its specific embodiments, it will be obvious to those skilled in the art from the viewpoint of the above description that many alternatives, variations, and modifications are apparent. Accordingly, all such alternatives, variations, and modifications are incorporated into the appended claims.

[0071] The above description is intended solely to illustrate the principles of the present invention. Furthermore, since many modifications and alterations are readily apparent to those skilled in the art, it is undesirable to limit the present invention to the works and processes described above. Accordingly, all suitable modifications and equivalents may be reclassified without departing from the scope of the present invention.

[0072] For the purpose of facilitating an understanding of the principles of the present invention, exemplary embodiments will be shown by the detailed description and examples above, and specific language will be used in the description. Nevertheless, it will be understood that this is not intended to limit the scope of the invention. Any alternative and further modifications of the inventive features described herein, as well as any additional uses of the principles of the invention as described herein, which may arise for those skilled in the art who are proprietary of this disclosure, will be considered without departing from the scope of the invention.

[0073] Throughout this specification, any reference to “Example,” “Case,” or similar language means a specific characteristic, structure, feature, or combination thereof described in connection with the Example, and is included in at least one of the Examples of the Invention. Therefore, throughout this specification, any expression such as “Example” and “Case,” and similar language, may, though not necessarily, refer to the same Example, a different Example, or one or more drawings. Furthermore, any reference to terms such as “Example” or “Case” for two or more characteristics or elements does not necessarily imply that the characteristics are related, different, or the same.

[0074] Each description of an embodiment or example should be considered independently of any other description of the embodiment, despite any use of similar or identical language characterizing each embodiment. Therefore, if an embodiment is identified as “another embodiment,” the identified embodiment is independent of any other embodiment characterized by the language “another embodiment.” The characteristics and functions described herein are considered to be able to be combined, in whole or in part, since the claims and / or the technical field may be directly or indirectly, implicitly or expressly indicated.

[0075] As used herein, “equipment,” “includes,” “contains,” “is,” “are,” “characterizes,” and their grammatical equivalents are inclusive or unrestrictive terms that do not exclude any additional elements or steps of method that are not enumerated. “Equipment” is interpreted more broadly and includes the more restrictive terms “consist of” and “consist of only.”

[0076] References to features, advantages, or similar terms throughout this specification do not imply that all features and advantages that can be implemented by the present invention should be or are contained in any single embodiment of the present invention. Rather, the language referring to features and advantages should be understood to mean that certain features, advantages, or characteristics described in relation to an embodiment are included in at least one embodiment of the present invention. For this reason, discussions of features, advantages, and similar terms throughout this specification may, though not necessarily, refer to the same embodiment.

[0077] Furthermore, the properties, advantages, and features described in the present invention may be combined in any suitable manner in one or more embodiments. Those skilled in the art will recognize that the present invention can be implemented without one or more specific properties or advantages in a particular embodiment. In other embodiments, additional properties and advantages may be recognized as predetermined embodiments that are not present in all embodiments of the present invention.

Claims

1. These are ophthalmic contact lenses, The first side curved surface and The flat surface on the second side opposite to the first side, One or more chamfered edges between the first side and the second side, having a circumference that is larger closer to the curved surface and smaller closer to the flat surface, A straight edge between the curved surface and the one or more chamfered edges oriented perpendicular to the flat surface, An ophthalmic contact lens comprising a light source that surrounds at least a portion of one or more beveled edges and contacts at least a portion of the one or more beveled edges.

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

3. The ophthalmic contact lens according to claim 1, wherein the angle of the one or more chamfered edges with respect to the flat surface is 0° to 90°.

4. The ophthalmic contact lens according to claim 1, wherein the angle of the one or more chamfered edges with respect to the flat surface is approximately 45°.

5. The ophthalmic contact lens according to claim 1, wherein the flat surface is slightly curved to widen the field of view through the lens and enable capturing the retina at a larger angle.

6. The ophthalmic contact lens according to claim 1, wherein the angle θ of one or more chamfered edges made of contact lens material with respect to the flat surface satisfies θ(rad) < π - 2 * arcsine(1 / n), where n is the refractive index of the contact lens material.

7. The ophthalmic contact lens according to claim 1, further comprising a cylindrical reflector facing one or more of the beveled edges and surrounding the light source.

8. The ophthalmic contact lens according to claim 1, wherein the light source comprises one or more light-emitting diodes.

9. The ophthalmic contact lens according to claim 1, further comprising a reflector having an upper wall portion connected to the side portion, wherein the upper wall portion is in contact with the flat surface and the side portion is connected to the straight edge portion.

10. These are ophthalmic contact lenses, The first side curved surface and The flat surface on the second side opposite to the first side, One or more chamfered edges between the first side and the second side, having a circumference that is larger closer to the curved surface and smaller closer to the flat surface, A straight edge between the curved surface and the one or more chamfered edges of the ophthalmic contact lens oriented perpendicular to the flat surface, An ophthalmic contact lens comprising a light source that contacts at least a portion of one or more of the beveled edges.

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

12. The ophthalmic contact lens according to claim 10, further comprising a cylindrical reflector facing one or more chamfered edges and surrounding the light source.

13. The ophthalmic contact lens according to claim 10, wherein the light source comprises one or more light-emitting diodes.

14. The ophthalmic contact lens according to claim 10, further comprising a reflector having an upper wall portion connected to the side portion, wherein the upper wall portion is in contact with the flat surface and the side portion is connected to the straight edge portion.

15. The ophthalmic contact lens according to claim 10, wherein the flat surface is slightly curved to widen the field of view through the lens and capture the retina at a larger angle.

16. The ophthalmic contact lens according to claim 10, wherein the angle of the one or more chamfered edges with respect to the flat surface is 0° to 90°.

17. The ophthalmic contact lens according to claim 10, wherein the angle of the one or more chamfered edges with respect to the flat surface is approximately 45°.

18. These are ophthalmic contact lenses, The first side curved surface and The flat surface on the second side opposite to the first side, One or more chamfered edges that cross the thickness of the material of the ophthalmic contact lens between the first side and the second side, having an angle θ with respect to the flat surface, A straight edge between the curved surface and the one or more chamfered edges oriented perpendicular to the flat surface, An ophthalmic contact lens comprising a light source surrounding at least a portion of one or more of the aforementioned beveled edges.

19. The ophthalmic contact lens according to claim 18, wherein the angle θ of one or more chamfered edges made of contact lens material with respect to the flat surface satisfies θ(rad) < π - 2 * arcsine(1 / n), where n is the refractive index of the contact lens material.

20. The ophthalmic contact lens according to claim 18, further comprising a cylindrical reflector facing each or more of the beveled edges and surrounding the light source.

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