Screening Protocol

Not Applicable

Terminated

• Conditions: Glaucoma
• Interventions: Device: Maestro2 OCT

• 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

Study Timeline

• Study Start: 2023-11-07
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

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

Arm && Interventions

Group	Intervention	Description
Pathology (glaucoma) arm	Maestro2 OCT	-
Normal arm	Maestro2 OCT	-

Primary Outcome Measures

Name	Time	Method
RNFL and GCL thickness	1 day	Using Maestro2 OCT

Trial Locations

Locations (1)

Topcon; 🇺🇸 La Jolla, California, United States