Screening Protocol

Glaucoma Clinical Trial

Official title:

Data Collection for Development of Topcon Health Score

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06135727
• Other study ID #: TPCN-2023-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 505
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Topcon	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNFL and GCL thickness	Using Maestro2 OCT	1 day