Assessment of EyeCheckup as an Automated Diabetic Retinopathy Screening Tool

Study Overview
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Brief Summary
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The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness. Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early. EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup. The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).

Detailed Description
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This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR. This study will be carried out in a single center at Akdeniz University Faculty of Medicine with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting. Methods and tools to be used in the study: Fundus photography with non-mydriatic camera and classification of diabetic retinopathy with artificial intelligence algorithm, Evaluation of images by retina specialists and comparison of results for clinical validation of the system. Clinical and laboratory tests to be performed: Fundus photography with a non-mydriatic camera. In this study, no invasive procedure is applied to the patient, the retinal photograph will be taken with a special digital camera called a fundus camera. In patients whose non-mydriatic image cannot be obtained, tropicamide drops will be instilled to dilate the pupil, and then photographs will be taken. Pupil dilation will be achieved by instilling Tropicamide drops in both eyes of the patient, and then 4 quadrant photographs of both eyes will be taken with a mydriatic fundus camera. After exclusions, this study will enroll up to 900 subjects who are diagnosed with diabetes by the endocrinology polyclinic and meet the eligibility criteria. Participants who meet the eligibility criteria will be recruited after obtaining written informed consent from primary health care providers. Subjects will undergo fundus photography per, Food and Drug Administration (FDA) cleared, ophthalmic cameras (product code: HKI). Images will be taken according to a specific EyeCheckup imaging protocol provided to the ophthalmic camera operator and then analyzed by the EyeCheckup device. The photography protocol consists of two images of the ocular fundus (one optic disc nerve centered, one macula centered), obtained from both eyes of enrolled participants. After the retinal images taken from ophthalmic cameras (product code: HKI), images are analyzed with EyeCheckup and a scan report is prepared. If it is necessary to enlarge the pupils, eye enlarging eye drops are applied and wait 15-30 minutes. This information is noted. DR is diagnosed by examination by a retina specialist with the captured images. EyeCheckup success rate is calculated by comparing both reports. The secondary purposes of the study are to prove that our product detects the presence of diabetic retinopathy.

Official Title
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Assessment of EyeCheckup as an Automated Diabetic Retinopathy Screening Tool

Conditions
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Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema

Intervention / Treatment
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* Procedure: Color fundus photography
* Drug: Mydriatic Agent
* Device: Diabetic retinopathy screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of diabetes mellitus Understanding of study and provision of written informed consent 18 years of age or older No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed) Other than cataract surgery, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease No media opacity precluding good retinal photography Exclusion Criteria: No diagnosis of diabetes mellitus Potential subject cannot understand study or informed consent A history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc Previous intraocular surgery other than cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy Pregnant women or women with gestational diabetes mellitus A media opacity in either eye that is severe enough to preclude good retinal photography Permanent vision impairment in one or both eyes The participant is contraindicated for imaging with fundus imaging systems used in the study: Participant is hypersensitive to light Participant recently received photodynamic therapy (PDT) Participant uses drugs that cause photosensitivity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Color fundus photography|Subjects will undergo fundus photography before and after administration of mydriatic agent.|
|Drug: Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.|
|Device: Diabetic retinopathy screening|Screening for existence of More than mild or Vision-threatening Diabetic Retinopathy, and/or Diabetic Macular Edema.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subject eyes whose EyeCheckup results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). | The performance of EyeCheckup will be evaluated using sensitivity and specificity measures. | 1 visit (1 day) | 
| Number of subject eyes whose EyeCheckup results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME). | The performance of EyeCheckup will be evaluated using sensitivity and specificity measures. | 1 visit (1 day) |