Clinical trial NCT06854198: Glaucoma Screening to Enhance At-Risk Californians' Health
Official title: Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: optical coherence tomography
tonometry
glaucoma
screening
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2025-03-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment
timeFrame: 3 months from randomization
Secondary outcomes:
measure: Cataract surgery
timeFrame: 12 months
measure: Eyeglasses
timeFrame: 12 months
measure: Quality of Life survey
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jeremy D Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Yvonne Ou, MD
role: PRINCIPAL_INVESTIGATOR
References: