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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Aarhus University Hospital

Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnant or lactating women

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Nov 30, 2011
Registry last updated: May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed