AI-Based Screening for Glaucoma

(GRaSS Trial)

Overseen By David S Friedman, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Non-diabetic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

David S Friedman, MD, PhD, MPH

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who are getting screened for diabetic retinopathy using the LumineticsCore system. They must be able to give informed consent. People without diabetes or not undergoing this specific AI-based screening are excluded.

Inclusion Criteria

I have diabetes and am getting AI-based diabetic retinopathy screening.

I am willing and able to agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Screening and Assessment

Participants undergo fundus photography, intraocular pressure measurement, and virtual perimetry testing if needed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for glaucoma detection and knowledge assessment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• AI-based glaucoma screening
• IOP measurement
• Virtual Reality Visual Field Testing

Trial Overview The study tests a new glaucoma screening method that includes an AI algorithm analyzing eye photos, measuring eye pressure, and testing side vision with virtual reality if needed.

How Is the Trial Designed?

Group I: Combined DED and Glaucoma Screening Experimental Treatment 3 Interventions

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.

Group II: DED Screening Only (Control Arm) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+