NCT02293174

Brief Summary

Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.

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 Sep 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

November 11, 2014

Last Update Submit

June 6, 2022

Conditions

Normal Healthy Subjects With no Known Ocular Diseases

Outcome Measures

Primary Outcomes (1)

  • Fundus Image Grading

    Determining the best display to reflect the real color of the retina

    1 Hour

Study Arms (1)

Normal Healthy Eyes

Willing and able subjects with normal and healthy eyes

Device: Topcon TRC-NW400Device: TRC-NW8Device: TRC-NW400Device: Canon-CR2Device: Zeiss Visucam PRO

Interventions

Topcon TRC-NW400DEVICE

Retinal Fundus Camera

Normal Healthy Eyes
TRC-NW8DEVICE

Retinal Fundus Camera

Normal Healthy Eyes
TRC-NW400DEVICE

Retinal Fundus Camera

Normal Healthy Eyes
Canon-CR2DEVICE

Retinal Fundus Camera

Normal Healthy Eyes
Zeiss Visucam PRODEVICE

Retinal Fundus Camera

Normal Healthy Eyes

Eligibility Criteria

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

Normal subjects will be recruited from Topcon Medical Systems.

You may qualify if:

  • Subjects with no known ocular diseases

You may not qualify if:

  • Subjects with known ocular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topcon Medical Systems, Inc.

Oakland, New Jersey, 07436, United States

Location

Study Officials

  • Danny Leung

    Clinical Trial Manager

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 18, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)