Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jesper Hjortdal, University of Aarhus
ClinicalTrials.gov Identifier:
First received: November 23, 2011
Last updated: May 27, 2015
Last verified: May 2015
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
Official Title: Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: Refraction one year after surgery ] [ Designated as safety issue: No ]
    Achieved change in refraction (spherical equivalent, SE) in diopters will be compared with attempted change in refraction (SE) in diopters. Data will be reported as fraction of eyes within an error (achieved - attempted) of +/- 0.5 diopters (SE) and within an error of +/- 1 diopters (SE).

  • Safety [ Time Frame: One year after surgery ] [ Designated as safety issue: Yes ]

    Data will be reported as:

    • Percentage of eyes with best spectacle corrected visual acuity (BSCVA) worse than 20/40 for eyes with BSCVA of 20/20 or better before survey
    • Percentage of eyes that lose 2 Snellen lines or more of BSCVA

Enrollment: 125
Study Start Date: February 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Detailed 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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for keratorefractive surgical correction of myopia

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01481792

Department of Ophthalmology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
  More Information

Responsible Party: Jesper Hjortdal, Professor, consultant, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01481792     History of Changes
Other Study ID Numbers: AUH-Ophthalmology-2011-01 
Study First Received: November 23, 2011
Last Updated: May 27, 2015
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Keratorefractive Surgical Procedures

Additional relevant MeSH terms:
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on April 27, 2016