NCT05286502

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

June 8, 2022

Status Verified

March 1, 2022

Enrollment Period

Same day

First QC Date

February 28, 2022

Last Update Submit

June 6, 2022

Conditions

Fundus Photography

Outcome Measures

Primary Outcomes (1)

  • fundus photo image quality

    1 day

Study Arms (1)

Adults 18 years old or older

Device: fundus photography

Interventions

fundus photographyDEVICE

color fundus photography

Adults 18 years old or older

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18 years old or older.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topcon Healthcare Solutions

Oakland, New Jersey, 07436, United States

Location

MeSH Terms

Interventions

Fluorescein Angiography

Intervention Hierarchy (Ancestors)

AngiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Ophthalmological

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 18, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

June 8, 2022

Record last verified: 2022-03

Locations

US(1)