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

Topcon Medical Systems, Inc.12 enrolled

Overview

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

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

Conditions

Subjects Presenting With Normal Eyes

Interventions

3D OCT-1 MaestroDEVICE

OCT Machine used for diagnostic purposes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Topcon Medical Systems, Inc.

Oakland, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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