Corneal Biomechanics With Hydration in Normal and LASIK Eyes

Deb Grzybowski

Status: Completed

Conditions: Laser Corneal Surgery

Treatments: Procedure: LASIK surgery; Other: No Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01183702

2004H002

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

non-LASIK

Active Comparator group

Description:

These participants have NOT had LASIK surgery.

Treatment:

Other: No Intervention

LASIK

Active Comparator group

Description:

These participants have had LASIK surgery.

Treatment:

Procedure: LASIK surgery