The Glaucoma and Retinopathy Screening Study (GRaSS)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Brigham and Women's Primary Care Associates of Longwood
RECRUITING
Boston
MGH Chelsea HealthCare Center
RECRUITING
Chelsea
NSPG Lynn
RECRUITING
Lynn
NSPG Salem
NOT_YET_RECRUITING
Salem
NSPG Saugus
RECRUITING
Saugus
Contact Information
Primary
David S Friedman, MD, PhD, MPH
grass@mgb.org
617-573-3094
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2030-09
Participants
Target number of participants: 2000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: Massachusetts Eye and Ear Infirmary