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Corneal Biomechanics With Hydration in Normal and LASIK Eyes

Sponsor
Deb Grzybowski (Other)
Overall Status
Completed
CT.gov ID
NCT01183702
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
106
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: LASIK surgery
  • Other: No Intervention
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Analysis of Corneal Biomechanics Based Upon Central and Peripheral Corneal Thickness in Normal and Post Refractive Surgery Eyes
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corneal hydration (swelling) [Two hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmology Department (Gowdy Field Building, 5th Floor) Columbus Ohio United States 43212

    Sponsors and Collaborators

    • Deb Grzybowski

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deb Grzybowski, Assistant Research Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT01183702
    Other Study ID Numbers:
    • 2004H002
    First Posted:
    Aug 18, 2010
    Last Update Posted:
    Jan 13, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Deb Grzybowski, Assistant Research Professor, Ohio State University
    LASIK vs. non-LASIK

    Study Results

    No Results Posted as of Jan 13, 2017