TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro

Completed

• Conditions: Subjects Presenting With Normal Eyes
• Interventions: Device: 3D OCT-1 Maestro

• Registration Number: NCT02447133
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

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

Detailed Description

Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Results First Submitted: 2016-07-14
• Results First Submitted QC: 2016-12-05
• Results First Posted: 2017-01-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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
Subjects Presenting With Normal Eyes	3D OCT-1 Maestro	Subjects with no known ocular diseases will be scanned on the Maestro device

Primary Outcome Measures

Name	Time	Method
TopQ Cut Off	1 hour	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.

Trial Locations

Locations (1)

Topcon Medical Systems, Inc.; 🇺🇸 Oakland, New Jersey, United States