Glaucoma Screening to Enhance At-Risk Californians' Health

NCT ID: NCT06854198

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-09-30

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Screening

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Education

Group Type ACTIVE_COMPARATOR

Educational Brochure

Intervention Type OTHER

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.

Delayed Education

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy D Keenan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Yvonne Ou, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Atnasia Mekonnen, MS

Role: CONTACT

818-618-6681

Dionna Wittberg, MPH

Role: CONTACT

330-308-3016

Other Identifiers

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U01DP006820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-43132

Identifier Type: -

Identifier Source: org_study_id

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