Efficacy and Safety of ReLEx Smile for Laser Correction of Myopia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jesper Hjortdal, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01481792
First received: November 23, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.


Condition
Myopia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: Refraction one year after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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


Enrollment: 125
Study Start Date: February 2011
Estimated Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for keratorefractive surgical correction of myopia

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481792

Locations
Denmark
Department of Ophthalmology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: Jesper Hjortdal, Professor, consultant, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01481792     History of Changes
Other Study ID Numbers: AUH-Ophthalmology-2011-01
Study First Received: November 23, 2011
Last Updated: January 11, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Keratorefractive Surgical Procedures

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014