Maestro Agreement and Precision Study II

Completed

• Conditions: Normal Healthy Subjects With No Known Ocular Diseases; Eyes With Retinal Diseases; Glaucomatous Eyes
• Interventions: Device: 3D OCT-1 Maestro; Device: iVue

• Registration Number: NCT02376868
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Study Start: 2015-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucomatous Eyes	3D OCT-1 Maestro	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Glaucomatous Eyes	iVue	Subjects presenting with different stages of glaucoma 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
Normal Eyes	3D OCT-1 Maestro	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Eyes with Retinal Diseases	3D OCT-1 Maestro	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Normal Eyes	iVue	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device

Primary Outcome Measures

Name	Time	Method
Optic Disc Measurements (Optic Disc/Cup Size)	1 Hour	Reporting of the Optic Disc Size and Cup Size
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours	1 Hour	RNFL thickness measured at different clock hours
Full Retinal Thickness Measurements	1 Hour	Full Retinal Thicknesses measured in different quadrants of the scan
Ganglion Cell Thickness Measurements	1 Hour	Ganglion Cell Thickness measured in different quadrants of the scan

Trial Locations

Locations (1)

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