Screening Protocol

Topcon

Status: Terminated

Conditions: Glaucoma

Treatments: Device: Maestro2 OCT

Study type: Observational

Funder types: Industry

Identifiers

NCT06135727

TPCN-2023-001

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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).
• 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

• 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

Trial design

26 participants in 2 patient groups

Pathology (glaucoma) arm

Treatment:

Device: Maestro2 OCT

Normal arm

Treatment:

Device: Maestro2 OCT