NCT02991027

Brief Summary

To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 14, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2017

Completed
Last Updated

December 16, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 9, 2016

Last Update Submit

December 10, 2021

Conditions

Healthy Eyes

Keywords

no known ocular pathology

Outcome Measures

Primary Outcomes (2)

  • OCT image quality

    5 minutes

  • OCT angiography image quality

    5 minutes

Secondary Outcomes (1)

  • Full Retinal Thickness

    5 minutes

Study Arms (1)

Subjects Presenting With Normal Eyes

EXPERIMENTAL

Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton

Device: DRI OCT Triton

Interventions

DRI OCT TritonDEVICE

DRI OCT Triton using micro-electro-mechanical short cavity tunable laser

Subjects Presenting With Normal Eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 18 years of age
  • They must be able to complete all testing (all OCT scans)
  • They 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
  • Subjects unable to complete all OCT imaging modes

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

  • Zhenguo Wang, PhD

    Topcon Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 13, 2016

Study Start

December 14, 2016

Primary Completion

June 12, 2017

Study Completion

July 2, 2017

Last Updated

December 16, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)