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Clinical Trials/NCT01183702
NCT01183702
Completed
Not Applicable

Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes

Deb Grzybowski1 site in 1 country44 target enrollmentFebruary 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laser Corneal Surgery
Sponsor
Deb Grzybowski
Enrollment
44
Locations
1
Primary Endpoint
Corneal hydration (swelling)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.

Detailed Description

The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas. Subjects' corneas will be swelled with warmed, humidified nitrogen using modified diving goggles to assess structural changes due to a two hour swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling and post-swelling data will be compared for parameters such as elasticity, density, thickness, axial and tangential curvature, hydration, and intraocular pressure in the central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data will allow for a better understanding of the structural changes created by LASIK. In addition, this project will allow for a better understanding of how common fluctuations in hydration levels affect normal corneal parameters as given by common devices in both populations to allow for corrections for more accurate measurements.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
December 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Deb Grzybowski
Responsible Party
Sponsor Investigator
Principal Investigator

Deb Grzybowski

Assistant Research Professor

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
  • Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.

Exclusion Criteria

  • Children under
  • Unhealthy cornea as determined by a registered ophthalmologist.

Outcomes

Primary Outcomes

Corneal hydration (swelling)

Time Frame: Two hours

Study Sites (1)

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