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A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01673503
Collaborator
Aarhus University Hospital (Other)
35
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.

Condition or Disease Intervention/Treatment Phase
  • Device: Carl Zeiss Meditech VisuMax laser
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
Study Start Date :
May 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Carl Zeiss Meditech VisuMax laser - ReLEx flex

>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile

Device: Carl Zeiss Meditech VisuMax laser
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
Other Names:
  • Refractive lenticule extraction, ReLEx

    		•
    Active Comparator: Carl Zeiss Meditech VisuMax laser - ReLEx smile

    >30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile

    Device: Carl Zeiss Meditech VisuMax laser
    Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
    Other Names:
  • Refractive lenticule extraction, ReLEx

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [up to 6 months]

      Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart

    Secondary Outcome Measures

    1. refractive predictability [Pre-surgery, 1 week, 1 month, 3 months, 6 months]

      Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability

    Other Outcome Measures

    1. Corneal biomechanics, corneal nerve changes and dry eye symptoms [pre-surgery and 6 months after]

      Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 25 to 45 years,

    • moderate to high myopia with astigmatism =< 2 D,

    • otherwise eye healthy,

    • CDVA of 0.8 or better (Snellen).

    Exclusion Criteria:

    • systemic or ocular disease or previous eye surgery,

    • thin cornea,

    • a difference of more than 2 D myopia in the eyes of each subject.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark Aarhus Denmark 8000

    Sponsors and Collaborators

    • Odense University Hospital
    • Aarhus University Hospital

    Investigators

    • Principal Investigator: Anders H Vestergaard, MD, Odense University Hospital, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anders H. Vestergaard, MD, PhD student, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT01673503
    Other Study ID Numbers:
    • S-20100111
    First Posted:
    Aug 28, 2012
    Last Update Posted:
    Jan 24, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Anders H. Vestergaard, MD, PhD student, University of Southern Denmark
    Myopia
    refractive surgery
    all femtosecond laser
    ReLEx flex
    ReLEx smile
    Additional relevant MeSH terms:
    Myopia
    Astigmatism

    Study Results

    No Results Posted as of Jan 24, 2013