Screening Protocol

September 2, 2025 updated by: Topcon Corporation

Data Collection for Development of Topcon Health Score

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Topcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects with normal eyes and eyes with moderate or severe glaucoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pathology (glaucoma) arm
Device: Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
Normal arm
Device: Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNFL and GCL thickness
Time Frame: 1 day
Using Maestro2 OCT
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Corporation

Investigators

  • Study Chair: Mary Durbin, PhD, Topcon Corporation
  • Principal Investigator: Nevin W. El-Nimri, OD, PhD, Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

August 2, 2024

Study Completion (Actual)

August 2, 2024

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPCN-2023-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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