Overview

This trial is active, not recruiting.

Condition laser corneal surgery
Treatments lasik surgery, no intervention
Sponsor Deb Grzybowski
Start date February 2004
End date December 2012
Trial size 44 participants
Trial identifier NCT01183702, 2004H002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
These participants have NOT had LASIK surgery.
no intervention Normal cornea
Participant has healthy eyes not altered by LASIK surgery.
(Active Comparator)
These participants have had LASIK surgery.
lasik surgery Refractive Surgery
Participants have received LASIK surgery and their eyes are healthy.

Primary Outcomes

Measure
Corneal hydration (swelling)
time frame: Two hours

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes
Principal investigator Deborah M Grzybowski, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Ohio State University.