The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

Study Overview
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Brief Summary
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In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.

Official Title
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Comparative Analysis of Diabetic Retinopathy Images by Retina Specialists Versus EyeStar's Artificial Intelligence Software of Images Captured by Pictor Plus Retinal Camera

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Other: Picture of the retina with a handheld retinal camera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed; Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates; Subjects who have been diagnosed with Type I or Type II diabetes mellitus. Exclusion Criteria: Subjects unable to tolerate ophthalmic imaging; Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy. Subject blind in one eye due to any cause Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

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 |
| --- |
|Other: Picture of the retina with a handheld retinal camera|Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects where the image readout by retina specialists match the readouts by EyeStar AI system for identifying diabetic eye disease | To quantify image analysis performance of the EyeStar AI system paired with Pictor Plus cameras for the detection of referable Diabetic Retinopathy (DR), defined as severe non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), or diabetic macular edema (DME) against adjudicated reads of retinal images by retina specialists | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with gradable images taken by the hand held camera | Pictures taken by the handheld retinal camera will be graded by the retina specialists for the quality of image for readouts | 3 months | 
| Number of subjects with ocular diseases other than diabetic retinopathy between the readout by the EyeStar AI system and those by the retina specialists | To assess the performance of the system in detection of other ocular diseases such as macular degeneration and glaucoma | 3 months |