AI-Assisted vs Conventional Teleglaucoma Referral (GATES)
Artificial Intelligence-Assisted Teleophthalmology for Glaucoma Screening: A Randomized Controlled Trial
This randomized controlled trial will compare an artificial intelligence (AI)-assisted teleglaucoma referral pathway with conventional referral among adults identified with referable glaucoma through the Los Angeles County Department of Health Services (LAC DHS) Teleretinal Screening Program. The primary objective is to determine whether AI-assisted referral reduces time to in-office diagnosis of manifest glaucoma. Secondary outcomes include glaucoma severity, visual function, need for glaucoma surgery, patient-reported quality of life and satisfaction, health system resource utilization, and cost-effectiveness.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants identified with referable glaucoma during routine teleretinal screening will be randomized 1:1 to an AI-assisted referral pathway or a conventional referral pathway.
In the AI-assisted arm, fundus photographs will be analyzed using validated deep learning models integrated within the Eye-AI platform. AI outputs, together with intraocular pressure and other clinical information, will be used to stratify referral urgency. AI-generated recommendations will undergo review by glaucoma specialists before referral.
In the conventional referral arm, fundus images will undergo manual review by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice.
Participants in both groups will undergo comprehensive in-office glaucoma evaluation following referral and will be followed for up to 36 months. The primary outcome is time from screening to in-office diagnosis of manifest glaucoma. Secondary outcomes will evaluate disease severity and visual function, need for glaucoma surgery, patient-reported quality of life and satisfaction, health system resource utilization, and cost-effectiveness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benjamin Y. Xu, MD, PhD
- Phone Number: 323-442-6425
- Email: benjamix@usc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of signed and dated informed consent
- Age ≥18 years
- Receiving routine teleretinal screening through the Los Angeles County Department of Health Services (LAC DHS) Teleretinal Screening Program
- Positive prediction for referable glaucoma by the validated AI algorithm at the time of screening
- No prior ophthalmology or optometry follow-up within the past year
- Willingness and ability to comply with study procedures and follow-up
Exclusion Criteria:
- Inability to tolerate fundus photography or ungradable fundus images
- Acute vision loss or major ocular complaints requiring immediate in-person evaluation
- Prior glaucoma diagnosis or treatment within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Assisted Teleglaucoma Referral
Participants will undergo AI-assisted referral using validated deep learning models integrated within the Eye-AI platform. AI outputs, together with intraocular pressure and other clinical information, will be used to stratify referral urgency. AI-generated recommendations will be reviewed by glaucoma specialists before referral. |
Fundus photographs acquired during routine teleretinal screening will be analyzed using validated deep learning models integrated within the Eye-AI platform. For participants identified with referable glaucoma, AI outputs will be combined with intraocular pressure and other clinical information to stratify referral urgency. All AI-generated recommendations will undergo review by a glaucoma specialist before referral. |
|
Active Comparator: Conventional Teleglaucoma Referral
Participants will undergo conventional teleglaucoma referral based on manual grading of fundus photographs by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice. |
Fundus photographs will undergo conventional manual grading by LAC DHS optometrists, with referral and prioritization performed according to current clinical practice. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to in-office diagnosis of glaucoma
Time Frame: From screening through 36 months
|
Number of days from the initial teleophthalmology screening to the first in-office glaucoma evaluation at which manifest glaucoma is diagnosed. |
From screening through 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual field mean deviation (MD)
Time Frame: Baseline and 36 months
|
Glaucoma disease severity assessed using visual field mean deviation (MD), measured in decibels (dB), at baseline and 36 months. |
Baseline and 36 months
|
|
Visual field index (VFI)
Time Frame: Baseline and 36 months
|
Glaucoma disease severity assessed using visual field index (VFI), expressed as a percentage (%), at baseline and 36 months. |
Baseline and 36 months
|
|
Mean retinal nerve fiber layer (RNFL) thickness
Time Frame: Time Frame: Baseline and 36 months
|
Glaucoma disease severity assessed using mean retinal nerve fiber layer (RNFL) thickness measured by optical coherence tomography (OCT), expressed in micrometers (µm), at baseline and 36 months. |
Time Frame: Baseline and 36 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APP-26-03722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared because patient-level health data from the Los Angeles County Department of Health Services (LAC DHS) are subject to HIPAA and LAC DHS data-sharing restrictions. Aggregate-level study results and derived analytic outputs will be shared in accordance with NIH policy and the approved Data Management and Sharing Plan.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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