NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Completed

• Conditions: Fundus Photography

• Registration Number: NCT05286502
• Lead Sponsor: Topcon Corporation

Brief Summary

Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-18
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subjects who are 18 years of age or older on the date of informed consent.
• Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.

Exclusion Criteria

• Subjects who are unable to tolerate ophthalmic imaging.
• Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
• Subjects who cannot follow instructions to complete the required testing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fundus photo image quality	1 day

Trial Locations

Locations (1)

Topcon Healthcare Solutions; 🇺🇸 Oakland, New Jersey, United States