Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With SD-OCT

March 28, 2016 updated by: Optovue
Evaluate the repeatability and reproducibility of the RTVue-XR for measuring the total corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping in normal subjects and corneal patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seeing eye doctor for routine or follow-up care

Description

Inclusion Criteria:

  • Able and willing to provide consent.
  • Able and willing to complete required exams
  • History of refractive surgery, contact lens, dry eye or keratoconus for corneal patients

Exclusion Criteria:

  • Unable to complete required exams
  • History of refractive surgery, contact lens, dry eye or keratoconus for normal patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
epithelial thickness
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Stromal thickness
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optovue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 200-50545

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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