NCT02982174

Brief Summary

Compare the signal to noise ratio of each device at various retinal layers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

Same day

First QC Date

November 29, 2016

Last Update Submit

June 6, 2022

Conditions

Healthy Eyes

Keywords

no known ocular pathology

Outcome Measures

Primary Outcomes (1)

  • Signal to noise ratio between SD OCT and SS OCT

    5 minutes

Study Arms (1)

Normal Eyes

Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton

Device: 3D OCT-1 MaestroDevice: DRI OCT Triton

Interventions

3D OCT-1 MaestroDEVICE

Image acquisition of the posterior surface of the eye

Normal Eyes
DRI OCT TritonDEVICE

Image acquisition of the posterior surface of the eye

Normal Eyes

Eligibility Criteria

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

30 subjects willing to participate in this study.

You may qualify if:

  • Male or female patients \> 18 years old who have full legal capacity to volunteer on the date the informed consent is signed.
  • Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date.
  • Subjects who agree to participate in the study.

You may not qualify if:

  • History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  • Fixation problems which may prevent obtaining good quality images in either eye.

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

November 29, 2016

First Posted

December 5, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)