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A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm
The Bausch & Lomb Zyoptix Tissue Saving algorithm
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Myopia with or without astigmatism. Normal Corneal topography Willing to have both eyes treated with the laser. Exclusion Criteria: Contraindications to LASIK.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Zyoptix Tissue Saving Aspheric

    Zyoptix Tissue Saving

    Arm Description

    The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

    The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.

    Outcomes

    Primary Outcome Measures

    Uncorrected visual acuity
    Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.

    Secondary Outcome Measures

    Deviation from target correction
    Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline

    Full Information

    First Posted
    June 30, 2006
    Last Updated
    December 7, 2011
    Sponsor
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00365677
    Brief Title
    A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia
    Official Title
    Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Astigmatism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    127 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zyoptix Tissue Saving Aspheric
    Arm Type
    Experimental
    Arm Description
    The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
    Arm Title
    Zyoptix Tissue Saving
    Arm Type
    Active Comparator
    Arm Description
    The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
    Intervention Type
    Device
    Intervention Name(s)
    The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm
    Intervention Description
    Used with LASIK treatment for the correction of myopia and myopic astigmatism.
    Intervention Type
    Device
    Intervention Name(s)
    The Bausch & Lomb Zyoptix Tissue Saving algorithm
    Intervention Description
    Used with LASIK treatment for the correction of myopia and myopic astigmatism.
    Primary Outcome Measure Information:
    Title
    Uncorrected visual acuity
    Time Frame
    At 90 days post surgery
    Title
    Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.
    Time Frame
    At 90 days post surgery
    Secondary Outcome Measure Information:
    Title
    Deviation from target correction
    Time Frame
    At 90 days post surgery
    Title
    Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline
    Time Frame
    At 90 days post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Myopia with or without astigmatism. Normal Corneal topography Willing to have both eyes treated with the laser. Exclusion Criteria: Contraindications to LASIK.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joanne Egamino, PhD
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

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