Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01481792

Enrollment

125

Registered

2011-11-30

Start date

2011-02-28

Completion date

2015-10-31

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Keratorefractive Surgical Procedures

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results