search
Back to results

A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

Primary Purpose

Myopia, Astigmatism

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
217z Laser
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. Exclusion Criteria: Contraindications to LASIK.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LASIK

    Arm Description

    LASIK correction of myopia and myopic astigmatism

    Outcomes

    Primary Outcome Measures

    Visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2006
    Last Updated
    December 7, 2011
    Sponsor
    Bausch & Lomb Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00347997
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Decision made by B&L to cancel the study, no subjects enrolled.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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
    A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LASIK
    Arm Type
    Experimental
    Arm Description
    LASIK correction of myopia and myopic astigmatism
    Intervention Type
    Device
    Intervention Name(s)
    217z Laser
    Intervention Description
    LASIK correction of myopia and myopic astigmatism
    Primary Outcome Measure Information:
    Title
    Visual acuity
    Time Frame
    24 months

    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. Exclusion Criteria: Contraindications to LASIK.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohinder Merchea, OD, PhD
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

    We'll reach out to this number within 24 hrs