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Screening Protocol

Sponsor
Topcon Corporation (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06135727
Collaborator
(none)
505
Enrollment
1
Location
2
Arms
24.8
Anticipated Duration (Months)
20.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Maestro2 OCT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
505 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Data Collection for Development of Topcon Health Score
Actual Study Start Date :
Nov 7, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Pathology (glaucoma) arm

Device: Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)
Other: Normal arm

Device: Maestro2 OCT
3D Wide (12mmx9mm) OCT scan using the Maestro (Topcon, Japan)

Outcome Measures

Primary Outcome Measures

  1. RNFL and GCL thickness [1 day]

    Using Maestro2 OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts 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).

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Topcon La Jolla California United States 92037

Sponsors and Collaborators

  • Topcon Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Topcon Corporation
ClinicalTrials.gov Identifier:
NCT06135727
Other Study ID Numbers:
  • TPCN-2023-001
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Glaucoma

Study Results

No Results Posted as of Nov 18, 2023