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

Topcon

Status: Completed

Conditions: Subjects Presenting With Normal Eyes

Treatments: Device: 3D OCT-1 Maestro

Study type: Observational

Funder types: Industry

Identifiers

NCT02447133

Topcon 001-2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

12 participants in 1 patient group

Subjects Presenting With Normal Eyes

Description:

Subjects with no known ocular diseases will be scanned on the Maestro device

Treatment:

Device: 3D OCT-1 Maestro