- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06854198
Glaucoma Screening to Enhance At-Risk Californians' Health (G-SEARCH)
Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dionna Wittberg, MPH
- Phone Number: 330-308-3016
- Email: dionna.wittberg@ucsf.edu
Study Contact Backup
- Name: Atnasia Mekonnen, MS
- Phone Number: 510-603-3330
- Email: atnasia.mekonnen@ucsf.edu
Study Locations
-
-
California
-
Oakland, California, United States, 94607
- Recruiting
- Baywell Health
-
Contact:
- Angela Shahbazian, OD, FAAO
- Phone Number: (510) 835-9610
- Email: a.shahbazian@berkeley.edu
-
San Francisco, California, United States, 94158
- Not yet recruiting
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Screening
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment
Time Frame: 3 months from randomization
|
3 months from randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cataract surgery
Time Frame: 12 months
|
Self-reported cataract surgery
|
12 months
|
|
Eyeglasses
Time Frame: 12 months
|
Self-reported purchase of new distance eyeglasses
|
12 months
|
|
Quality of Life survey
Time Frame: 12 months
|
Self-reported quality of life on VisQol instrument
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeremy D Keenan, MD, MPH, University of California, San Francisco
- Principal Investigator: Yvonne Ou, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-43132
- U01DP006820 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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