Skip to content

The Glaucoma and Retinopathy Screening Study

The Glaucoma and Retinopathy Screening Study (GRaSS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06882356
Acronym
GRaSS
Enrollment
2000
Registered
2025-03-18
Start date
2025-07-16
Completion date
2030-09-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DEVICEAI-based glaucoma screening

AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening

Intraocular pressure measurement by Icare tonometer

DEVICEVirtual Reality Visual Field Testing

Virtual Reality Visual Field Testing by the Olleyes device for participants suspected of having glaucoma

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER
Centers for Disease Control and Prevention
CollaboratorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system at primary care centers. * Individuals who are able and willing to provide informed consent for participation in the study.

Design outcomes

Primary

MeasureTime frameDescription
Glaucoma detection1 year from initial screeningThis primary outcome measure will assesses the proportion of participants who receive a glaucoma diagnosis in the combined DED and glaucoma screening group compared to the DED-only screening group. Glaucoma diagnosis in the intervention group is based on AI-assisted analysis of fundus photography, intraocular pressure, and virtual reality perimetry testing for confirmation.

Secondary

MeasureTime frameDescription
Cost-Effectiveness of Combined Screening vs. DED-Only Screening1 year from initial screening
Participant Satisfaction with Screening ProcessDay of screeningThis measure assesses participant satisfaction with the glaucoma screening process. Satisfaction will be evaluated through a participant satisfaction survey.
Participant knowledge about glaucomaDay of screeningThis measure assesses participants' knowledge about glaucoma. Knowledge will be assessed through a questionnaire (NEI Glaucoma Eye-Q test).

Countries

United States

Contacts

CONTACTDavid S Friedman, MD, PhD, MPH
grass@mgb.org617-573-3094
PRINCIPAL_INVESTIGATORDavid S Friedman, MD, PhD, MPH

Massachusetts Eye and Ear

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026