An interventional study of AI-based glaucoma screening and IOP measurement in Glaucoma, sponsored by Massachusetts Eye and Ear Infirmary. Recruiting at 7 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Screening
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
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will have fundus photographs taken for diabetic eye disease screening analyzed by AI for signs of glaucoma. They will also have intraocular pressure measured. If glaucoma is suspected, participants will undergo virtual perimetry testing for further assessment.
Device: AI-based glaucoma screening · Device: IOP measurement · Device: Virtual Reality Visual Field Testing
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.
AI analysis of fundus photographs to detect signs of glaucoma, added to AI-based diabetic eye disease screening
Intraocular pressure measurement by Icare tonometer
Virtual Reality Visual Field Testing by the Olleyes device for participants suspected of having glaucoma
Glaucoma detection
This 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.
Time frame: 1 year from initial screening
Cost-Effectiveness of Combined Screening vs. DED-Only Screening
Time frame: 1 year from initial screening
Participant Satisfaction with Screening Process
This measure assesses participant satisfaction with the glaucoma screening process. Satisfaction will be evaluated through a participant satisfaction survey.
Time frame: Day of screening
Participant knowledge about glaucoma
This measure assesses participants' knowledge about glaucoma. Knowledge will be assessed through a questionnaire (NEI Glaucoma Eye-Q test).
Time frame: Day of screening
Plan to share: Yes — Deidentified study data
Time frame: After study completion
Access criteria: Data sharing will require adherence to Mass General Brigham institutional and IRB policies. External researchers will need to contact the Principal Investigator to request data and complete a Data Use Agreement. Only deidentified data will be shared.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Sep 2030, 62 months after the start.
Of 229 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 62 months is above that.
Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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