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The Glaucoma and Retinopathy Screening Study

NCT06882356 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-08-28

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a new screening approach including an artificial intelligence algorithm that analyzes fundus photographs, measurement of eye pressure and visual field testing works to screen for glaucoma.

Participants will:

Have an image of their fundus (back of the eye) taken as part of their diabetic eye screening Have a measurement of their eye pressure If needed, have a test of their side vision using a headset

Conditions

Interventions

DEVICE

AI-based glaucoma screening

AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening performed for routine clinical care

DEVICE

IOP measurement

Intraocular pressure measurement by Icare tonometer

DEVICE

Virtual Reality Visual Field Testing

Virtual Reality Visual Field Testing by the Olleyes device for participants suspected of having glaucoma

Sponsors & Collaborators

Principal Investigators

  • David S Friedman, MD, PhD, MPH · Massachusetts Eye and Ear

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2030-09-30
Completion
2030-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882356 on ClinicalTrials.gov