NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

Topcon

Status: Completed

Conditions: Fundus Photography

Treatments: Device: fundus photography

Study type: Observational

Funder types: Industry

Identifiers

NCT05286502

THS-TPCN-2022-001

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Adults 18 years old or older

Treatment:

Device: fundus photography