Clinical Trial: Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism

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

Official Title: A Prospective Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of Naturally Occuring Mixed

Brief Summary: The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of mixed astigmatism up to 6.0 D, 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 mixed astigmatism procedure, a combination of both a steepening (hyperopic treatment) and a flattening (myopic treatment) occur on the corneal surface. 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 mixed astigmatic 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 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 ]
  • 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: Postoperative visits ]
  • Incidence of adverse events to occur in less than 1% of eyes [ Time Frame: Postoperative visits ]


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 and 12 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 and 12 months ]


Original Secondary Outcome: Same as current

Information By: Carl Zeiss Meditec, Inc.

Dates:
Date Received: September 26, 2008
Date Started: January 2007
Date Completion:
Last Updated: August 22, 2013
Last Verified: August 2013