Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia
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 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|
- 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
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481792
|Department of Ophthalmology, Aarhus University Hospital|
|Aarhus C, Denmark, 8000|