Clinical Study of the Optic Disc Parameters

Not Applicable

Completed

• Conditions: Normal Healthy Subjects With No Known Ocular Diseases; Eyes With Retinal Diseases; Glaucomatous Eyes
• Interventions: Device: Maestro; Device: iVue

• Registration Number: NCT02277119
• Lead Sponsor: Topcon Medical Systems, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-28
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Results First Submitted: 2016-05-31
• Results First Submitted QC: 2016-09-14
• Results First Posted: 2016-11-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucomatous Eyes	iVue	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Normal Eyes	iVue	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Eyes with Retinal Diseases	Maestro	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Normal Eyes	Maestro	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Eyes with Retinal Diseases	iVue	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Glaucomatous Eyes	Maestro	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device

Primary Outcome Measures

Name	Time	Method
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements	1 Hour	RNFL thickness measured
Full Retinal Thickness Measurement	1 Hour	Full Retinal Thicknesses Measurement
Optic Disc Measurement (Cup Size)	1 Hour	Reporting of the Cup size difference between the Maestro and iVue
Optic Disc Measurements (Optic Disc Size)	1 Hour	Reporting of the Optic Disc Size difference between the Maestro and iVue

Trial Locations

Locations (2)

Western University of Health Sciences; 🇺🇸 Pomona, California, United States

SUNY College of Optometry; 🇺🇸 New York, New York, United States