Clinical Trial: Safety and Effectiveness Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Hyperopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized, Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of ≤ +6.0 D Of

Brief Summary: The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.

Detailed Summary: LASIK has become one of the most common refractive eye procedures performed in the country. In the hyperopia procedure, a steepening occurs on the corneal surface, rather than the flattening procedure (myopic treatment). The surgeon will produce a standard keratomileusis flap using a microkeratome, exposing the corneal stroma. Recontouring under the flap is then accomplished by the removal of tissue from the stroma with the laser. This recontouring results in an altering of effective lens power of the central cornea, measured in diopters (D). The MEL 80 Excimer Laser System will be evaluated for its ability to create accurate and stable hyperopic refractive correction results.
Sponsor: Carl Zeiss Meditec, Inc.

Current Primary Outcome:

  • At the point of stability, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome. [ Time Frame: Point of stability ]
  • A minimum of 85% of eyes targeted for emmetropia should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established. [ Time Frame: Point of stability ]
  • A minimum of 95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D. [ Time Frame: Point of stability ]
  • 75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability. [ Time Frame: Point of stability ]
  • Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1.0% of eyes that had a BSCVA of 20/20 or better before surgery. [ Time Frame: Point of stability ]
  • Loss of more than 2 lines of BSCVA should occur in less than 5.0% of eyes. [ Time Frame: Point of stability ]
  • Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established. [ Time Frame: Point of stability ]
  • Incidence of A

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable. [ Time Frame: Postoperative visits 3, 6, 9, 12, 18 and 24 months ]
    • Incidence of Complications [ Time Frame: Postoperative visits ]
    • Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable. [ Time Frame: Preoperative and Postoperative visits 3, 6, 9, 12, 18 and 24 months ]


    Original Secondary Outcome: Same as current

    Information By: Carl Zeiss Meditec, Inc.

    Dates:
    Date Received: September 26, 2008
    Date Started: July 2004
    Date Completion:
    Last Updated: August 9, 2012
    Last Verified: August 2012