NCT00396188

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

Corneal Analysis - Pathology Detection Aid

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 769 (actual)
• Sponsor: Carl Zeiss Meditec, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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).

Conditions

• Corneal Diseases

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-11-06
• Last updated: 2015-08-17

Locations

4 sites across 1 country: United States