Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia
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|ClinicalTrials.gov Identifier: NCT01481792|
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : May 12, 2016
|Condition or disease|
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|
|Official Title:||Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction|
|Study Start Date :||February 2011|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2015|
- 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).
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01481792
|Department of Ophthalmology, Aarhus University Hospital|
|Aarhus C, Denmark, 8000|