NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

NCT ID: NCT05286502

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-03-01

Brief Summary

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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

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Conditions

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Fundus Photography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults 18 years old or older

fundus photography

Intervention Type DEVICE

color fundus photography

Interventions

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fundus photography

color fundus photography

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Topcon Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Topcon Healthcare Solutions

Oakland, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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THS-TPCN-2022-001

Identifier Type: -

Identifier Source: org_study_id

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