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| ID | Type | Description | Link |
|---|---|---|---|
| U01DP006820 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Experimental |
| |
| Education | Active Comparator |
| |
| Delayed Education | No Intervention | The same as the Educational Brochure arm, but delivered at the conclusion of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment | 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Cataract surgery | Self-reported cataract surgery | 12 months |
| Eyeglasses | Self-reported purchase of new distance eyeglasses | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Atnasia Mekonnen, MS | Contact | 510-603-3330 | atnasia.mekonnen@ucsf.edu | |
| Dionna Wittberg, MPH | Contact | 330-308-3016 | dionna.wittberg@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy D Keenan, MD, MPH | University of California, San Francisco | Principal Investigator |
| Yvonne Ou, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baywell Health | Recruiting | Oakland | California | 94607 | United States |
treatment arm, age, gender, results of diagnostic tests, 3-month and 12-month questionnaires
After publication of the primary papers.
Researchers interested in accessing imaging data from this project will submit requests to the investigators following instructions available at the repository. The study's co-PIs will approve requests with clear research questions and processes in place to ensure secure storage of images.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| D008365 | Manometry |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Educational Brochure | 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. |
|
| Quality of Life survey | Self-reported quality of life on VisQol instrument | 12 months |
| University of California, San Francisco | Not yet recruiting | San Francisco | California | 94158 | United States |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |