Recruiting

Glaucoma Screening

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06882356

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

AI-based glaucoma screening

IOP measurement

Virtual Reality Visual Field Testing

Study Details

Brief 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

Glaucoma

Study ID

NCT06882356

Start date

Jul 16, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

  • Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system at primary care centers.
  • Individuals who are able and willing to provide informed consent for participation in the study.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Combined DED and Glaucoma Screening

Participants in this arm will have fundus photographs taken for diabetic eye disease screening analyzed by AI for signs of glaucoma. They will also have intraocular pressure measured. If glaucoma is suspected, participants will undergo virtual perimetry testing for further assessment.

no intervention: DED Screening Only (Control Arm)

Participants in this arm will undergo diabetic eye disease (DED) screening only for routine clinical care. This includes fundus photography for AI assessment of signs of diabetic retinopathy.

Interventions

AI-based glaucoma screening

AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening

IOP measurement

Intraocular pressure measurement by Icare tonometer

Virtual Reality Visual Field Testing

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

Primary outcome measure

  • Glaucoma detection [ Time Frame: 1 year from initial screening ]

Central Contacts and Locations

Central contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

Locations

Massachusetts General Hospital Internal Medicine Associates

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

Brigham and Women's Primary Care Associates of Longwood

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

Massachusetts General Hospital Broadway Primary Care-Revere

Recruiting

Boston, Massachusetts, United States, 02151

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

MGH Chelsea HealthCare Center

Recruiting

Chelsea, Massachusetts, United States, 02150

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

NSPG Lynn

Recruiting

Lynn, Massachusetts, United States, 01904

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

NSPG Saugus

Recruiting

Saugus, Massachusetts, United States, 01906

Contacts

David S Friedman, MD, PhD, MPH

617-573-3094grass@mgb.org

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-08-27.