Clinical Trial: Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Corneal Analysis - Pathology Detection Aid

Brief Summary: 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) and to determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas.

Detailed Summary:

  1. To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
  2. To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
  3. To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
  4. To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
  5. To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
  6. To establish reference values for SF, CIM, and TKM in subjects with previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface that are not listed above.
  7. To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
  8. To determine the sensitivity, specificity, and accuracy of the Pathfinder II Corneal Analysis software in discriminating normal corneas from previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface (Phase II).

Sponsor: Carl Zeiss Meditec, Inc.

Current Primary Outcome: Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer [ Time Frame: 1-2 hours ]

Original Primary Outcome:

Current Secondary Outcome: Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas [ Time Frame: 1-2 hours ]

Original Secondary Outcome:

Information By: Carl Zeiss Meditec, Inc.

Dates:
Date Received: November 2, 2006
Date Started: February 2007
Date Completion:
Last Updated: August 13, 2015
Last Verified: August 2015