NCT06854198

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Sep 2029

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

February 25, 2025

Last Update Submit

April 13, 2026

Conditions

Glaucoma

Keywords

optical coherence tomographytonometryglaucomascreening

Outcome Measures

Primary Outcomes (1)

  • Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment

    3 months from randomization

Secondary Outcomes (3)

  • Cataract surgery

    12 months

  • Eyeglasses

    12 months

  • Quality of Life survey

    12 months

Study Arms (3)

Screening

EXPERIMENTAL
Other: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry

Education

ACTIVE COMPARATOR
Other: Educational Brochure

Delayed Education

NO INTERVENTION

The same as the Educational Brochure arm, but delivered at the conclusion of the study.

Interventions

Educational BrochureOTHER

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.

Education
Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometryOTHER

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.

Screening

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baywell Health

Oakland, California, 94607, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94158, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical CoherenceManometry

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Jeremy D Keenan, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Yvonne Ou, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Atnasia Mekonnen, MS

CONTACT

510-603-3330atnasia.mekonnen@ucsf.edu

Dionna Wittberg, MPH

CONTACT

330-308-3016dionna.wittberg@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

February 10, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

treatment arm, age, gender, results of diagnostic tests, 3-month and 12-month questionnaires

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the primary papers.
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.

Locations

US(2)