Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia
- Conditions
- Myopia
- Registration Number
- NCT01481792
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Indication for keratorefractive correction of myopia
- Patient consent to undergo keratorefractive correction of myopia
- Pregnant or lactating women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness 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).
Safety 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Ophthalmology, Aarhus University Hospital
🇩🇰Aarhus C, Denmark