Glaucoma Screening to Enhance At-Risk Californians' Health

Not Applicable

Not yet recruiting

• Conditions: Glaucoma

• Registration Number: NCT06854198
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Status Verified: 2025-03
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Study Start: 2025-09
• Primary Completion: 2029-03
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment	3 months from randomization

Secondary Outcome Measures

Name	Time	Method
Cataract surgery	12 months	Self-reported cataract surgery
Eyeglasses	12 months	Self-reported purchase of new distance eyeglasses
Quality of Life survey	12 months	Self-reported quality of life on VisQol instrument

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States