TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

Healthy Eyes Clinical Trial

Official title:

TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022383
• Other study ID #: Topcon Triton 1222-2016
• Status: Completed
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Eyes

Intervention

Device:
• DRI OCT Triton plus
OCT Machine used for diagnostic purposes

Locations

Country	Name	City	State
United States	Topcon Medical Systems Inc.	Oakland	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement Variability of Signal to Noise Ratio		1 hour