Evaluation of Corneal Epithelial Thickness Mapping

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optovue
ClinicalTrials.gov Identifier:
NCT01712022
First received: October 19, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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
Dry Eye and Contact Lens Wear

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Corneal Epithelial Thickness Mapping

Resource links provided by NLM:


Further study details as provided by Optovue:

Primary Outcome Measures:
  • corneal epithelial thickness [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

seeing eye doctor for routine or follow-up care

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712022

Locations
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
Optovue
  More Information

No publications provided

Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT01712022     History of Changes
Other Study ID Numbers: 200-48071
Study First Received: October 19, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014