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Clinical Trials/NCT02277119
NCT02277119CompletedNot Applicable

Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue

Topcon Medical Systems, Inc.3 sites in 1 country109 target enrollmentStarted: October 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
109
Locations
3
Primary Endpoint
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Retinal Nerve Fiber Layer (RNFL) Thickness Measurements

Time Frame: 1 Hour

RNFL thickness measured

Full Retinal Thickness Measurement

Time Frame: 1 Hour

Full Retinal Thicknesses Measurement

Optic Disc Measurement (Cup Size)

Time Frame: 1 Hour

Reporting of the Cup size difference between the Maestro and iVue

Optic Disc Measurements (Optic Disc Size)

Time Frame: 1 Hour

Reporting of the Optic Disc Size difference between the Maestro and iVue

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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Clinical Study of the Optic Disc Parameters | Clinical Trial