Corneal Biomechanics With Hydration in Normal and LASIK Eyes
The research will utilize LASIK and non-LASIK populations to analyze the biomechanical differences between these corneas.
|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|
- Corneal hydration (swelling) [ Time Frame: Two hours ] [ Designated as safety issue: No ]
|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)|
Active Comparator: non-LASIK
These participants have NOT had LASIK surgery.
Other: No Intervention
Participant has healthy eyes not altered by LASIK 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183702
|United States, Ohio|
|Ophthalmology Department (Gowdy Field Building, 5th Floor)|
|Columbus, Ohio, United States, 43212|
|Principal Investigator:||Deborah M Grzybowski, PhD||Ohio State University|