Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

Brief Summary

Official Title: “Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction”

Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: October 2014

Detailed Clinical Trial Description

Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital.

The patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.

Outcome Measures for this Clinical Trial

Primary Measures

  • Effectiveness
    • Time Frame: Refraction one year after surgery
      Safety Issue?: No
  • Safety
    • Time Frame: One year after surgery
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Indication for keratorefractive correction of myopia
  • Patient consent to undergo keratorefractive correction of myopia

Exclusion Criteria

  • Pregnant or lactating women

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jesper Hjortdal, Professor, consultant, MD, PhD – University of Aarhus


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