Evaluation of Corneal Epithelial Thickness Mapping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712022
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease
Dry Eye and Contact Lens Wear

Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Corneal Epithelial Thickness Mapping
Study Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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

Primary Outcome Measures :
  1. corneal epithelial thickness [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
seeing eye doctor for routine or follow-up care

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712022

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

Responsible Party: Optovue Identifier: NCT01712022     History of Changes
Other Study ID Numbers: 200-48071
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014