NCT02447133

Brief Summary

The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 31, 2017

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

Same day

First QC Date

May 11, 2015

Results QC Date

July 14, 2016

Last Update Submit

June 6, 2022

Conditions

Subjects Presenting With Normal Eyes

Keywords

no known ocular pathology

Outcome Measures

Primary Outcomes (1)

  • TopQ Cut Off

    To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.

    1 hour

Study Arms (1)

Subjects Presenting With Normal Eyes

Subjects with no known ocular diseases will be scanned on the Maestro device

Device: 3D OCT-1 Maestro

Interventions

3D OCT-1 MaestroDEVICE

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
  • 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
  • TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topcon Medical Systems, Inc.

Oakland, New Jersey, 07436, United States

Location

Results Point of Contact

Title
Charles Reisman
Organization
Topcon
CREISMAN@topcon.com
201-599-5283

Study Officials

  • Randy Sun, MD

    Topcon Corporation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 18, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 29, 2022

Results First Posted

January 31, 2017

Record last verified: 2022-06

Locations

US(1)