Screening Protocol

Data Collection for Development of Topcon Health Score

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06135727

Enrollment

Registered

2023-11-18

Start date

2023-11-07

Completion date

2024-08-02

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DEVICEMaestro2 OCT

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
RNFL and GCL thickness	1 day	Using Maestro2 OCT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026