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:
- To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
- To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
- To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
- 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.
- To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
- 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