TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

• Sponsor: Topcon Medical Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03022383
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Eyes	Device: 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 Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Subjects Presenting With Normal Eyes Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device	Device: DRI OCT Triton plus; OCT Machine used for diagnostic purposes

Outcome Measures

Primary Outcome Measures

1. Measurement Variability of Signal to Noise Ratio [1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Participants must be at least 18 years of age

• Participants must be able to complete all testing (all OCT scans)

• Participants must volunteer to be in the study and sign the consent form

Exclusion Criteria

• Subject with history of ocular disease or ocular pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Topcon Medical Systems Inc.	Oakland	New Jersey	United States	07436

Sponsors and Collaborators

• Topcon Medical Systems, Inc.

Investigators

• Principal Investigator: Wei-Chieh Huang, PhD, Topcon Medical Systems, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT03022383
• Other Study ID Numbers: Topcon Triton 1222-2016
• First Posted: Jan 16, 2017
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Topcon Medical Systems, Inc.: no known ocular pathology

Study Results

No Results Posted as of Jun 8, 2022