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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Sponsor
Edward E. Manche (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01135719
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
200
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LASIK and PRK
 N/A

Detailed Description

Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Study Start Date :
Apr 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wavefront guided LASIK/PRK

Wavefront-guided LASIK/PRK

Procedure: LASIK and PRK
Wavefront-guided versus wavefront-optimized LASIK or PRK.
Other Names:
  • Allegretto Wave Eye-Q 400 Hz excimer laser
  • Visx CustomVue excimer laser
  • Laser in-situ keratomileusis
  • Photorefractive keratectomy
  • Wavefront-guided
  • Wavefront-optimized

    		•
    Active Comparator: Wavefront optimized LASIK/PRK

    Wavefornt optimized LASIK/PRK

    Procedure: LASIK and PRK
    Wavefront-guided versus wavefront-optimized LASIK or PRK.
    Other Names:
  • Allegretto Wave Eye-Q 400 Hz excimer laser
  • Visx CustomVue excimer laser
  • Laser in-situ keratomileusis
  • Photorefractive keratectomy
  • Wavefront-guided
  • Wavefront-optimized

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in best spectacle corrected visual acuity. [One year]

    2. Changes in 25 and 5% low contrast visual acuity. [One year]

    3. Improvement in uncorrected visual acuity [One year]

    Secondary Outcome Measures

    1. Changes in higher order aberrations. [One year]

    2. Topographic changes. [One year]

    3. Quality of vision changes. [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy subjects age 21 and older.

    • Subjects with nearsightedness, farsightedness and/or astigmatism.

    Exclusion Criteria:Autoimmune diseases.

    • Children.

    • Women pregnant or nursing.

    • Ectatic corneal disease.

    • Previous ocular surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Edward E. Manche

    Investigators

    • Principal Investigator: Edward E. Manche, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward E. Manche, Stanford University School of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01135719
    Other Study ID Numbers:
    • SU-04302009-2458
    First Posted:
    Jun 3, 2010
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Edward E. Manche, Stanford University School of Medicine, Stanford University
    Myopia
    Hyperopia
    Astigmatism
    PRK
    LASIK
    Additional relevant MeSH terms:
    Myopia
    Astigmatism
    Hyperopia

    Study Results

    No Results Posted as of Nov 9, 2021