TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

Completed

• Conditions: Healthy Eyes
• Interventions: Device: DRI OCT Triton plus

• Registration Number: NCT03022383
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

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: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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	DRI OCT Triton plus	Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device

Primary Outcome Measures

Name	Time	Method
Measurement Variability of Signal to Noise Ratio	1 hour

Trial Locations

Locations (1)

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