NCT03694145

Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.

Detailed description

This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center. For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination. The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.

Conditions

• Diabetic Retinopathy
• Diabetic Macular Edema

Interventions

Type	Name	Description
OTHER	In-Person Eye Examination	Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.

Timeline

• Start date: 2018-10-25
• Primary completion: 2025-05-31
• Completion: 2025-07-31
• First posted: 2018-10-03
• Last updated: 2025-02-14

Locations

3 sites across 1 country: United States