Corneal Biomechanics With Hydration in Normal and LASIK Eyes

January 11, 2017 updated by: Deb Grzybowski

Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Ophthalmology Department (Gowdy Field Building, 5th Floor)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-LASIK
These participants have NOT had LASIK surgery.
Other: No Intervention
Participant has healthy eyes not altered by LASIK surgery.
Other Names:
  • Normal cornea
  • no refractive surgery
Active Comparator: LASIK
These participants have had LASIK surgery.
Procedure: LASIK surgery
Participants have received LASIK surgery and their eyes are healthy.
Other Names:
  • Refractive Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal hydration (swelling)
Time Frame: Two hours
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deb Grzybowski

Investigators

  • Principal Investigator: Deborah M Grzybowski, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2004H002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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