Wavefront-guided PRK vs Wavefront-optimized PRK

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02091934
Collaborator
(none)
71
1
2
36
2

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the results of PRKK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism

Condition or Disease Intervention/Treatment Phase
  • Procedure: Wavefront-guided PRK
  • Procedure: Wavefront-optimized PRK
N/A

Detailed Description

This is a research study comparing the outcomes of PRK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 50 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo refractive keratectomy (PRK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will not know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) PRK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo PRK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Patients will complete questionnaires preoperatively and postoperatively evaluating quality of vision and quality of life. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your PRK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.

Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.

Study Design

Study Type:
Interventional
Actual Enrollment :
71 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 Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser
Actual Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Mar 31, 2012
Actual Study Completion Date :
Mar 31, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wavefront-guided PRK

Wavefront-guided PRK

Procedure: Wavefront-guided PRK
Wavefront-guided PRK
Other Names:
  • Alcon Wavelight Eye-Q 400 wavefront-guided PRK
  • Active Comparator: Wavefront-optimized PRK

    Wavefront-optimized PRK

    Procedure: Wavefront-optimized PRK
    Wavefront-optimized PRK
    Other Names:
  • Alcon Wavelight Eye-Q 400 wavefront-optimized PRK
  • Outcome Measures

    Primary Outcome Measures

    1. Uncorrected visual acuity [One year]

      Uncorrected visual acuity

    Secondary Outcome Measures

    1. Topographic analysis [One year]

      Topographic analysis

    2. Wavefront analysis [One year]

      Wavefront analysis

    3. Quality of vision and quality of life questionnaire [One year]

      Patient Reported Outcomes Questionnaire

    4. Corneal haze [One year]

      Corneal haze

    5. Changes in best corrected 5 and 25% contrast visual acuity [One year]

      Changes in best corrected 5 and 25% contrast visual acuity

    6. Changes in best corrected visual acuity [One year]

      Changes in best corrected visual acuity

    7. Refractive predictability [One year]

      Refractive predictability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Subjects age 21 and older with healthy eyes.

    • Nearsightedness between -0.25 diopters and -8.00 diopters with or without astigmatism of up to 5.00 diopters.

    Exclusion Criteria:
    • Subjects under the age of 21.

    • Excessively thin corneas.

    • Topographic evidence of keratoconus.

    • Ectactic eye disorders.

    • Autoimmune diseases.

    • Pregnant or nursing.

    • Patients must have similar levels of nearsightedness in each eye. They can not be more than 2.5 diopter of difference between eyes.

    • Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Eye Laser Center Palo Alto California United States 94303

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Edward E Manche, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edward E. Manche, Professor of Ophthalmology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02091934
    Other Study ID Numbers:
    • Stanford IRB #29233
    First Posted:
    Mar 19, 2014
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Edward E. Manche, Professor of Ophthalmology, Stanford University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 8, 2021