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Corneal Biomechanics With Hydration in Normal and LASIK Eyes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deb Grzybowski, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01183702
First received: August 13, 2010
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Laser Corneal Surgery
 Procedure: LASIK surgery
Other: No Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Corneal hydration (swelling) [ Time Frame: Two hours ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: February 2004
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: non-LASIK
These participants have NOT had LASIK surgery.
 Other: No Intervention
Participant has healthy eyes not altered by LASIK surgery.
Other Names:
  • Normal cornea
  • no refractive surgery
Active Comparator: LASIK
These participants have had LASIK surgery.
 Procedure: LASIK surgery
Participants have received LASIK surgery and their eyes are healthy.
Other Name: Refractive Surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 18.
  • Unhealthy cornea as determined by a registered ophthalmologist.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183702

Locations
United States, Ohio
Ophthalmology Department (Gowdy Field Building, 5th Floor)
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Deb Grzybowski
Investigators
Principal Investigator: Deborah M Grzybowski, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Deb Grzybowski, Assistant Research Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01183702     History of Changes
Other Study ID Numbers: 2004H002
Study First Received: August 13, 2010
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
LASIK vs. non-LASIK

ClinicalTrials.gov processed this record on May 16, 2013