Combined glaucoma screening during diabetic eye exams
The Glaucoma and Retinopathy Screening Study (GRaSS)
This program tests whether adding an AI review of retinal photos, a quick eye pressure check, and a virtual-reality side-vision test to routine diabetic eye screening helps find glaucoma earlier in people with diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 5 sites (Boston, Massachusetts and 4 other locations) |
| Trial ID | NCT06882356 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional program that embeds an AI-based glaucoma screen into existing diabetic eye disease screenings at community primary care centers. Participants receive fundus photography analyzed by an AI algorithm (LumineticsCore), measurement of intraocular pressure, and a virtual-reality visual field test when indicated. The approach targets people with diabetes because they have higher risk for glaucoma and already attend retinal photo screening. The goal is to increase detection of undiagnosed glaucoma and enable earlier treatment while using existing screening encounters.
Who should consider this trial
Good fit: Adults with diabetes who are undergoing diabetic retinopathy screening using the LumineticsCore system at one of the participating primary care centers and who can give informed consent are ideal candidates.
Not a fit: People without diabetes, those not screened with the LumineticsCore workflow at participating sites, or patients with already-known or very advanced glaucoma are unlikely to gain additional benefit from the added screening components.
Why it matters
Potential benefit: If successful, the program could identify glaucoma earlier in high-risk patients with diabetes so treatment can begin sooner and vision loss may be reduced or delayed.
How similar studies have performed: AI systems have shown good performance for diabetic retinopathy detection and some optic nerve changes on fundus photos, but AI-based glaucoma screening combined with virtual-reality visual field testing is less extensively validated and remains an active area of research.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Boston, Massachusetts and 4 other locations
- Brigham and Women's Primary Care Associates of Longwood — Boston, Massachusetts, United States (Recruiting)
- MGH Chelsea HealthCare Center — Chelsea, Massachusetts, United States (Recruiting)
- NSPG Lynn — Lynn, Massachusetts, United States (Recruiting)
- NSPG Salem — Salem, Massachusetts, United States (Not_yet_recruiting)
- NSPG Saugus — Saugus, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David S Friedman, MD, PhD, MPH — Massachusetts Eye and Ear
- Study coordinator: David S Friedman, MD, PhD, MPH
- Email: grass@mgb.org
- Phone: 617-573-3094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.