RecruitingNot ApplicableNCT06882356

The Glaucoma and Retinopathy Screening Study

The Glaucoma and Retinopathy Screening Study (GRaSS)


Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

2,000 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 40 Years

Inclusion Criteria2

  • 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.

Interventions

DEVICEAI-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

DEVICEIOP measurement

Intraocular pressure measurement by Icare tonometer

DEVICEVirtual Reality Visual Field Testing

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


Locations(5)

Brigham and Women's Primary Care Associates of Longwood

Boston, Massachusetts, United States

MGH Chelsea HealthCare Center

Chelsea, Massachusetts, United States

NSPG Lynn

Lynn, Massachusetts, United States

NSPG Salem

Salem, Massachusetts, United States

NSPG Saugus

Saugus, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06882356


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