Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Retinal Diseases, In-Person Eye Examination

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients diagnosed with Type I or Type II Diabetes
  • Patients who are over the age of 18 years
  • Patients who have not previously been seen in the current year by the LACDHS Teleretinal Diabetic Retinopathy Screening Program and Reading Center
  • Patients whose teleretinal screening exam images yield readable results

You CAN'T join if...

  • Patients under the age of 18 years
  • Patients with gestational diabetes
  • Patients who have previously been seen in the current year by LACDHS's Teleretinal Diabetic Retinopathy Screening Program and Reading Center
  • Patients whose teleretinal screening exam images do not yield readable results, as gradable images are needed for later comparison against ophthalmologist reads.
  • Previously eligible patients who do not return for an in-person eye exam within 3 months of receiving a teleretinal screening (In order for the results of the teleretinal screening and in-person eye examinations to yield similar information, patients who do not return for their in-person eye exam within 3 months of their teleretinal screening will not be able to remain in the study. This is because significant eye changes not documented by the teleretinal screening may occur after a 3-month period).

Locations

  • University of California - Los Angeles
    Los Angeles California 90024 United States
  • Los Angeles Department of Public Health
    Los Angeles California 90012 United States
  • Charles R. Drew University of Medicine and Science
    Los Angeles California 90059 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Charles Drew University of Medicine and Science
ID
NCT03694145
Study Type
Observational
Participants
About 300 people participating
Last Updated