We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corneal Biomechanics With Hydration in Normal and LASIK Eyes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01183702
First Posted: August 18, 2010
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deb Grzybowski, The Ohio State University
  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: None (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

Further study details as provided by Deb Grzybowski, The Ohio State University:

Primary Outcome Measures:
  • Corneal hydration (swelling) [ Time Frame: Two hours ]

Enrollment: 44
Study Start Date: February 2004
Study Completion Date: December 2012
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Deb Grzybowski, Assistant Research Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01183702     History of Changes
Other Study ID Numbers: 2004H002
First Submitted: August 13, 2010
First Posted: August 18, 2010
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Deb Grzybowski, The Ohio State University:
LASIK vs. non-LASIK