Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481792
• Other study ID #: AUH-Ophthalmology-2011-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2011
• Last updated: May 27, 2015
• Start date: February 2011
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Indication for keratorefractive correction of myopia

• Patient consent to undergo keratorefractive correction of myopia

Exclusion Criteria:

• Pregnant or lactating women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myopia

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness	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).	Refraction one year after surgery	No
Primary	Safety	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	One year after surgery	Yes