Evaluation of Corneal Epithelial Thickness Mapping

September 9, 2014 updated by: Optovue
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

88

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
    • California
      • Palo Alto, California, United States, 94301
        • Fishman Vision
      • San Diego, California, United States, 92122
        • Gordon-Weiss-Schanzlin Vision Institute
    • New York
      • Latham, New York, United States, 12110
        • Brass Eye Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

seeing eye doctor for routine or follow-up care

Description

Inclusion Criteria:

  • 18 years of age or older
  • Able and willing to provide consent
  • Able and willing to complete the required examinations
  • DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
  • CONTACT LENS GROUP ONLY: Regular contact lens wear

Exclusion Criteria:

  • History of ocular surgery
  • History of laser refractive surgery
  • History of cataract surgery
  • DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
  • CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
  • NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology

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

Cohorts and Interventions

Group / Cohort
Dry Eye
clinical diagnosis of dry eye
Contact Lens
routine wear of contact lens
Normal
Not having history of dry eye or contact lens wear or corneal pathology or surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
corneal epithelial 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, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimate)

October 23, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200-48071

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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