Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
26 participants
OBSERVATIONAL
2023-11-07
2024-08-02
Brief Summary
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In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Pathology (glaucoma) arm
Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
Normal arm
Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
Interventions
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Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
22 Years
ALL
Yes
Sponsors
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Topcon Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Durbin, PhD
Role: STUDY_CHAIR
Topcon Corporation
Nevin W. El-Nimri, OD, PhD
Role: PRINCIPAL_INVESTIGATOR
Topcon Corporation
Locations
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Topcon
La Jolla, California, United States
Countries
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Other Identifiers
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TPCN-2023-001
Identifier Type: -
Identifier Source: org_study_id
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