Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

NCT03694145 | Active Not Recruiting DMC

• 2 other identifiers: 1218589-3R01LM012309
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Proportion of patients accurately diagnosed with retinopathy

  Proportion of patients accurately diagnosed with retinopathy using machine learning versus proportion accurately diagnosed by teleretinal screening optometrists with in-person eye examinations by ophthalmologists used as a gold standard.

  11/2022

Study Arms (1)

Diabetic patients w. risk of retinopathy

The 300-500 patients to be enrolled for the study are diabetic patients normally seen by the Los Angeles County Department of Health Services (LACDHS) Teleretinal Diabetic Retinopathy Screening Program and Reading Center. In addition to receiving their recommended LACDHS annual teleretinal screening, for the study, participants will receive an additional in-person eye examination.

Other: In-Person Eye Examination

Interventions

In-Person Eye Examination OTHER

Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.

Diabetic patients w. risk of retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients with Type I or Type II diabetes who are normally seen at LACDHS clinics and usually screened for diabetic retinopathy via teleretinal screening.

You may qualify if:

• 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 may not qualify 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).

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Library of Medicine (NLM): collaborator
• Los Angeles County Department of Public Health: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

Los Angeles Department of Public Health

Los Angeles, California, 90012, United States

Location

University of California - Los Angeles

Los Angeles, California, 90024, United States

Location

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Omolola Ogunyemi, PhD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 25, 2018
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)