Status:
TERMINATED
Screening Protocol
Lead Sponsor:
Topcon Corporation
Conditions:
Glaucoma
Eligibility:
All Genders
22+ years
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 prospe...
Eligibility Criteria
Inclusion
- 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).
- Normal eyes to have normal ocular examination in both eyes
- Normal eyes to have IOP ≤ 21 mmHg in both eyes
- Pathology eyes to have clinical diagnosis of mild or moderate glaucoma in at least one eye
Exclusion
- 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.
- Pathology eyes with severe glaucoma
- Pathology eyes with glaucoma suspect diagnosis
- Pathology eyes with Ocular Hypertensive diagnosis
Key Trial Info
Start Date :
November 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06135727
Start Date
November 7 2023
End Date
August 2 2024
Last Update
September 10 2025
Active Locations (1)
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1
Topcon
La Jolla, California, United States, 92037