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Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions
This study has been completed.
Sponsored by: Carl Zeiss Meditec, Inc.
Information provided by: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT00396188
  Purpose

The purpose of this study is to determine the ability of a proprietary software screening tool to discriminate normal corneas (front surface of the eye) from previously diagnosed corneal conditions (diseases/surgeries/pathologies).


Condition Phase
Corneal Diseases
Phase I

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Corneal Analysis - Pathology Detection Aid

Further study details as provided by Carl Zeiss Meditec, Inc.:

Estimated Enrollment: 792
Study Start Date: February 2007
Study Completion Date: February 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Normals

  • Patients seeking initial laser vision correction that were screened to be good candidates for the procedure.
  • No history of refractive or other ocular surgery.
  • No corneal pathologies.
  • Normal corneal topography.
  • Contact lens wearers should discontinue use at least 2 weeks for hard contacts, and 3 days for soft lenses prior to imaging.

Keratoconus

  • An irregular cornea determined by distorted keratometry mires, distortion of the retinoscopic, or ophthalmoscopic red reflex (or a combination of these)
  • At least one of the following biomicroscopic signs: Vogt's striae, Fleischer's ring of >2 mm arc, or corneal scarring consistent with keratoconus.
  • Contact lens wearers should discontinue use preferably 1 day or at least half an hour prior to imaging.

Myopic Laser Vision Correction

Patients who have undergone myopic:

  • LASIK
  • PRK
  • LASEK

Hyperopic Laser Vision Correction

Patients who have undergone hyperopic:

  • LASIK
  • PRK
  • LASEK

Orthokeratology

  • Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
  • Subjects must be 18 years of age or older; able and willing to make the required visit; and able and willing to give consent.

Exclusion Criteria:

  • Patients that underwent corneal transplantation or any ocular surgery for the following categories: normal, keratoconus, and orthokeratology)
  • Any active infection or inflammation of the cornea.
  • PI decides that subject is not suitable due to medical risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396188

Locations
United States, California
Shiley Eye Center-University of California San Diego
La Jolla, California, United States, 92093
Carmel Mountain Vision Care Center
San Diego, California, United States, 92129
United States, Colorado
Dishler Laser Institute
Greenwood Village, Colorado, United States, 80111
United States, Oregon
Pacific University
Forest Grove, Oregon, United States, 97116
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Investigators
Principal Investigator: Jon Dishler, M. D. Dishler Laser Institute
Principal Investigator: David J Schanzlin, M. D. Shiley Eye Center-University of California San Diego
Principal Investigator: Dennis Burger, O. D. Kaiser Permanente, Oakland
Principal Investigator: Patrick Caroline, COT Pacific University
Principal Investigator: Tyson Brunstetter, O. D. Naval Training Center-Refractive Surgery Clinic
Principal Investigator: Kevin Reeder, O.D. Carmel Mountain Vision Care Center
  More Information

Publications:
Study ID Numbers: Atlas II-2006-1-v1
Study First Received: November 2, 2006
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00396188  
Health Authority: United States: Institutional Review Board

Keywords provided by Carl Zeiss Meditec, Inc.:
Keratoconus
LASIK
Orthokeratology
Pellucid Marginal Degeneration
Refractive Surgery
normal cornea
post myopic LASIK
post hyperopic LASIK
corneal pathologies (e.g. pellucid marginal degeneration)

Study placed in the following topic categories:
Corneal Diseases
Eye Diseases
Keratoconus

ClinicalTrials.gov processed this record on January 14, 2009