NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05286502

Enrollment

Registered

2022-03-18

Start date

2022-03-01

Completion date

2022-03-01

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fundus Photography

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)

Interventions

DEVICEfundus photography

color fundus photography

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
fundus photo image quality	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026