Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01481792
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Jesper Hjortdal, University of Aarhus

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

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction
Study Start Date : February 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Primary Outcome Measures :
  1. Effectiveness [ Time Frame: Refraction one year after surgery ]
    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).

  2. Safety [ Time Frame: One year after surgery ]

    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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481792

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

Responsible Party: Jesper Hjortdal, Professor, consultant, MD, PhD, University of Aarhus Identifier: NCT01481792     History of Changes
Other Study ID Numbers: AUH-Ophthalmology-2011-01
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Jesper Hjortdal, University of Aarhus:
Keratorefractive Surgical Procedures

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases