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

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Glaucoma

Treatments: Other: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry; Other: Educational Brochure

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06854198

24-43132

U01DP006820 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 3 patient groups

Screening

Experimental group

Treatment:

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

Education

Active Comparator group

Treatment:

Other: Educational Brochure

Delayed Education

No Intervention group

Description:

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