Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06882356

The Glaucoma and Retinopathy Screening Study

Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-08-28

2000

Participants Needed

5

Research Sites

267 weeks

Total Duration

On this page

Sponsors

M

Massachusetts Eye and Ear Infirmary

Lead Sponsor

C

Centers for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Glaucoma and Retinopathy Screening Study

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system for clinical care at primary care centers.
  • Individuals who are able and willing to provide informed consent for participation in the study.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Brigham and Women's Primary Care Associates of Longwood

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

MGH Chelsea HealthCare Center

Chelsea, Massachusetts, United States, 02150

Actively Recruiting

3

NSPG Lynn

Lynn, Massachusetts, United States, 01904

Actively Recruiting

4

NSPG Salem

Salem, Massachusetts, United States, 01970

Not Yet Recruiting

5

NSPG Saugus

Saugus, Massachusetts, United States, 01906

Actively Recruiting

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Research Team

D

David S Friedman, MD, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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