NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
Sponsor
Topcon Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT05286502
Collaborator
(none)
10
1
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
Actual Study Start Date
:
Mar 1, 2022
Actual Primary Completion Date
:
Mar 1, 2022
Actual Study Completion Date
:
Mar 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Adults 18 years old or older
|
Device: fundus photography
color fundus photography
|
Outcome Measures
Primary Outcome Measures
- fundus photo image quality [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Topcon Healthcare Solutions | Oakland | New Jersey | United States | 07436 |
Sponsors and Collaborators
- Topcon Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Topcon Corporation
ClinicalTrials.gov Identifier:
NCT05286502
Other Study ID Numbers:
- THS-TPCN-2022-001
First Posted:
Mar 18, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No