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RECRUITING Not applicable ClinicalTrials.gov

The Glaucoma and Retinopathy Screening Study

Sponsor: Massachusetts Eye and Ear Infirmary • ClinicalTrials.gov ID: NCT06882356

Registry updated: 2026-08-27
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Description

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

Interventions

  • AI-based glaucoma screening (Device)
    AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening
  • IOP measurement (Device)
    Intraocular pressure measurement by Icare tonometer
  • Virtual Reality Visual Field Testing (Device)
    Virtual Reality Visual Field Testing by the Olleyes device for participants suspected of having glaucoma

Eligibility criteria

* 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.

Conditions

Glaucoma

Locations

  • Massachusetts General Hospital Internal Medicine Associates — Boston, Massachusetts, United States
  • Brigham and Women's Primary Care Associates of Longwood — Boston, Massachusetts, United States
  • Massachusetts General Hospital Broadway Primary Care-Revere — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record