Glaucoma Screening to Enhance At-Risk Californians' Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry, Educational Brochure.
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations
Overview
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.
Interventions
- Other 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. - 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.
Primary outcome measures
- Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment [Time frame: 3 months from randomization]
Secondary outcome measures (3)
- Cataract surgery [Time frame: 12 months]
- Eyeglasses [Time frame: 12 months]
- Quality of Life survey [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
United States · 2 centers
- Baywell Health — Oakland
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06854198 · 24-43132 · U01DP006820