The Glaucoma and Retinopathy Screening Study

Conditions

• Glaucoma

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jul 16, 2025

Status verified

Jun 2025

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

2,000 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Combined DED and Glaucoma Screening
  Participants in this arm will have fundus photographs that are taken as a part of standard clinical care analyzed by AI for signs of glaucoma in addition to for diabetic retinopathy. They will also have intraocular pressure measured. If the AI detects possible glaucoma, 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.

Primary Outcome Measure

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

Central Contacts

• David S Friedman, MD, PhD, MPH
  617-573-3094
  [email protected]

Locations (5)

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