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

Corneal Diseases Clinical Trial

Official title:
Corneal Analysis - Pathology Detection Aid

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00396188
Study type Observational
Source Carl Zeiss Meditec, Inc.
Contact
Status Completed
Phase Phase 1
Start date February 2007
Completion date February 2008
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