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

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

Study Overview

• Status: Completed
• Conditions: Subjects Presenting With Normal Eyes
• Intervention / Treatment: Device: 3D OCT-1 Maestro

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Oakland, New Jersey, United States, 07436
      • Topcon Medical Systems, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with no known eye disease

Description

Inclusion Criteria

1. Participants must be at least 18 years of age
2. They must be able to complete all testing (all OCT scans)
3. They must volunteer to be in the study and sign the consent form

Exclusion Criteria

1. Subject with history of ocular disease or ocular pathology
2. TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects Presenting With Normal Eyes; Subjects with no known ocular diseases will be scanned on the Maestro device	Device: 3D OCT-1 Maestro; OCT Machine used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TopQ Cut Off	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.	1 hour

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.
• Investigators: Principal Investigator: Randy Sun, MD, Topcon Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: no known ocular pathology
• Other Study ID Numbers: Topcon 001-2015