Clinical trial NCT06882356: The Glaucoma and Retinopathy Screening Study
Official title: The Glaucoma and Retinopathy Screening Study (GRaSS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2025-03-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a prospective interventional model to evaluate the effectiveness of integrating AI-based glaucoma screening with existing diabetic eye disease (DED) screening among diabetic patients. Participants will have fundus images assessed by AI for glaucoma in addition to DED, and have intraocular pressure measurement measured. Suspected glaucoma cases will receive virtual perimetry testing for confirmation, and those diagnosed with glaucoma will be referred for follow-up care. This study aims to compare glaucoma detection rates between combined DED and glaucoma screening versus DED-only screening, ultimately supporting early glaucoma detection and enhancing care access in underserved communities.
Primary purpose: SCREENING

Brief 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

Detailed description: Study Overview: This study is a prospective, interventional clinical trial designed to evaluate the effectiveness of an artificial intelligence (AI)-based screening program within community health settings. This study targets especially diabetic patients because they have higher risks of developing glaucoma. By integrating glaucoma screening into existing diabetic eye disease (DED) screenings, the study aims to identify cases of glaucoma earlier, thereby preventing or delaying progression to blindness.

Background: Glaucoma is a chronic eye disease that causes progressive optic nerve damage, often leading to irreversible vision loss. Early detection is critical, as glaucoma is typically asymptomatic in its early stages. Individuals with diabetes are at an elevated risk for glaucoma, making it crucial to develop accessible screening methods. Current DED screening programs already utilize fundus photography for diabetic retinopathy. Adding glaucoma screening to these existing DED screenings may provide an efficient and cost-effective solution to reach high-risk populations without requiring additional clinic visits.

Study Hypothesis: The hypothesis of this study is that incorporating AI-driven glaucoma screening into standard DED screenings will increase the detection rate of glaucoma in high-risk populations compared to DED screening alone. This combined approach is expected to yield better clinical outcomes by enabling early diagnosis and treatment while being cost-effective.

Expected Outcomes and Impact: This study is expected to provide valuable insights into the effectiveness of integrating AI-based glaucoma screening into existing screening programs for diabetic eye disease. If successful, this combined screening approach could be a cost-effective model for other community health settings, leading to earlier detection of glaucoma and improved patient outcomes. By making glaucoma screening more accessible the study aims to reduce health disparities and support preventive eye care.

Eligibility 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.

Primary outcomes:
measure: Glaucoma detection
timeFrame: 1 year from initial screening
Secondary outcomes:
measure: Cost-Effectiveness of Combined Screening vs. DED-Only Screening
timeFrame: 1 year from initial screening
measure: Participant Satisfaction with Screening Process
timeFrame: Day of screening
measure: Participant knowledge about glaucoma
timeFrame: Day of screening
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Eye and Ear
name: David S Friedman, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: