Glaucoma Screening to Enhance At-Risk Californians' Health (G-SEARCH)

Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations

The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Other: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry; Other: Educational Brochure

Detailed Description

Specific Aim 1: To determine the effectiveness of a telemedicine-based glaucoma screening program for detecting glaucoma. The investigators hypothesize that a mobile screening intervention incorporating optical coherence tomography (OCT), fundus photography, and tonometry will result in a greater number of new glaucoma diagnoses compared to education alone or delayed treatment.

Specific Aim 2: To determine whether a telemedicine-based glaucoma screening program provides benefits beyond glaucoma detection. The investigators hypothesize that (A) individuals randomized to the screening intervention will have higher rates of cataract surgery and distance vision correction one year after screening, and (B) those in the screening intervention will report higher vision-related quality of life one year after screening.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dionna Wittberg, MPH; Phone Number: 330-308-3016; Email: dionna.wittberg@ucsf.edu
• Study Contact Backup: Name: Atnasia Mekonnen, MS; Phone Number: 510-603-3330; Email: atnasia.mekonnen@ucsf.edu

Study Locations

• United States
  • California
    • Oakland, California, United States, 94607
      • Recruiting
      • Baywell Health
      • Contact: Angela Shahbazian, OD, FAAO; Phone Number: (510) 835-9610; Email: a.shahbazian@berkeley.edu
    • San Francisco, California, United States, 94158
      • Not yet recruiting
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Black people aged 50 years or older
• Hispanic people aged 65 years or older
• People with diabetes aged 50 years or older
• Must have been seen at the Federally Qualified Health Center (FQHC) within the past month

Exclusion Criteria:

• Patients without a valid phone number or mailing address
• Patients who have had an optometry appointment within the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening	Other: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry; Participants will be called and offered a screening appointment. At the appointment, visual acuity, OCT, color fundus photography, tonometry, and visual field testing will be performed. The images will be assessed for abnormalities. Participants meeting referral criteria will be referred for a comprehensive eye examination with an eye care provider.
Active Comparator: Education	Other: Educational Brochure; A brochure about glaucoma screening will be mailed to participants. The brochure will include contact information of a staff member who can schedule an appointment for a comprehensive eye examination.
No Intervention: Delayed Education; The same as the Educational Brochure arm, but delivered at the conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment	3 months from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cataract surgery	Self-reported cataract surgery	12 months
Eyeglasses	Self-reported purchase of new distance eyeglasses	12 months
Quality of Life survey	Self-reported quality of life on VisQol instrument	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Jeremy D Keenan, MD, MPH, University of California, San Francisco; Principal Investigator: Yvonne Ou, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: optical coherence tomography; screening; glaucoma; tonometry
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence; Manometry
• Other Study ID Numbers: 24-43132; U01DP006820 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: treatment arm, age, gender, results of diagnostic tests, 3-month and 12-month questionnaires
• IPD Sharing Time Frame: After publication of the primary papers.
• IPD Sharing Access Criteria: Researchers interested in accessing imaging data from this project will submit requests to the investigators following instructions available at the repository. The study's co-PIs will approve requests with clear research questions and processes in place to ensure secure storage of images.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No