NCT03022383

Brief Summary

To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

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 Jan 2017

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

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

January 11, 2017

Last Update Submit

June 6, 2022

Conditions

Healthy Eyes

Keywords

no known ocular pathology

Outcome Measures

Primary Outcomes (1)

  • Measurement Variability of Signal to Noise Ratio

    1 hour

Study Arms (1)

Subjects Presenting With Normal Eyes

Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device

Device: DRI OCT Triton plus

Interventions

DRI OCT Triton plusDEVICE

OCT Machine used for diagnostic purposes

Subjects Presenting With Normal Eyes

Eligibility Criteria

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

Subjects with no known eye disease.

You may qualify if:

  • Participants must be at least 18 years of age
  • Participants must be able to complete all testing (all OCT scans)
  • Participants must volunteer to be in the study and sign the consent form

You may not qualify if:

  • Subject with history of ocular disease or ocular pathology

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

  • Wei-Chieh Huang, PhD

    Topcon Medical Systems, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)