Screening Protocol

NCT ID: NCT06135727

Last Updated: 2025-09-10

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-08-02

Brief Summary

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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

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pathology (glaucoma) arm

Maestro2 OCT

Intervention Type DEVICE

3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)

Normal arm

Maestro2 OCT

Intervention Type DEVICE

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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Topcon Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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TPCN-2023-001

Identifier Type: -

Identifier Source: org_study_id

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