Corneal Biomechanics With Hydration in Normal and LASIK Eyes

Not Applicable

Completed

• Conditions: Laser Corneal Surgery
• Interventions: Procedure: LASIK surgery; Other: No Intervention

• Registration Number: NCT01183702
• Lead Sponsor: Deb Grzybowski

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LASIK	LASIK surgery	These participants have had LASIK surgery.
non-LASIK	No Intervention	These participants have NOT had LASIK surgery.

Primary Outcome Measures

Name	Time	Method
Corneal hydration (swelling)	Two hours

Trial Locations

Locations (1)

Ophthalmology Department (Gowdy Field Building, 5th Floor); 🇺🇸 Columbus, Ohio, United States