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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Screening
  • 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.
Active Comparator
Education
  • 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.
No Intervention
Delayed Education 		The same as the Educational Brochure arm, but delivered at the conclusion of the study.

Recruiting Locations

Baywell Health
Oakland, California 94607
Contact:
Angela Shahbazian, OD, FAAO
(510) 835-9610
a.shahbazian@berkeley.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Atnasia Mekonnen, MS
510-603-3330
atnasia.mekonnen@ucsf.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.