Corneal Biomechanics With Hydration in Normal and LASIK Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Laser Corneal Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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non-LASIK

These participants have NOT had LASIK surgery.

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

Participant has healthy eyes not altered by LASIK surgery.

LASIK

These participants have had LASIK surgery.

Group Type ACTIVE_COMPARATOR

LASIK surgery

Intervention Type PROCEDURE

Participants have received LASIK surgery and their eyes are healthy.

Interventions

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LASIK surgery

Participants have received LASIK surgery and their eyes are healthy.

Intervention Type PROCEDURE

No Intervention

Participant has healthy eyes not altered by LASIK surgery.

Intervention Type OTHER

Other Intervention Names

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Refractive Surgery Normal cornea no refractive surgery

Eligibility Criteria

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Inclusion Criteria

* Healthy cornea without LASIK surgery as determined by a registered ophthalmologist.
* Healthy cornea with LASIK surgery as determined by a registered ophthalmologist.