Screening Protocol

NCT06135727 | Terminated FDA Device

• 1 other identifier: TPCN-2023-001
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• RNFL and GCL thickness

  Using Maestro2 OCT

  1 day

Study Arms (2)

Pathology (glaucoma) arm

Device: Maestro2 OCT

Normal arm

Device: Maestro2 OCT

Interventions

Maestro2 OCT DEVICE

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

Normal arm; Pathology (glaucoma) arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with normal eyes and eyes with moderate or severe glaucoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (1)

Topcon

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Mary Durbin, PhD

  Topcon Corporation

  STUDY CHAIR

• Nevin W. El-Nimri, OD, PhD

  Topcon Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 7, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: September 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)