Screening Protocol
Not Applicable
Terminated
- Conditions
- Glaucoma
- Registration Number
- NCT06135727
- Lead Sponsor
- Topcon Corporation
- Brief Summary
The objective of this study is to collect data for the development and validation a screening process using aggregate data.
In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
- For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- BCVA 20/40 or better (each eye).
Exclusion Criteria
- For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
- Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
- History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
- Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
- Unreliable VF testing and/or poor-quality OCT scans.
- Poor fixation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method RNFL and GCL thickness 1 day Using Maestro2 OCT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Topcon
🇺🇸La Jolla, California, United States
Topcon🇺🇸La Jolla, California, United States