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OpenTrials
Completed

NCT Number: NCT02447133

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.

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Key information

Conditions

Subjects Presenting With Normal Eyes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Topcon Medical Systems, Inc.

Oakland, New Jersey, 07436, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

3D OCT-1 Maestro

Device

OCT Machine used for diagnostic purposes

Primary outcomes

  1. TopQ Cut Off

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2015
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.