Wavefront-guided LASIK for Correction of Myopia

This study has been withdrawn prior to enrollment.
(Institution changed surgical method to small-incision lenticule extraction. Study never started.)
Sponsor:
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01682434
First received: September 4, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.

Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.

The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.


Condition Intervention
Myopia
Procedure: Laser in situ keratomileusis (LASIK)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Wavefront-guided LASIK for Correction of Myopia

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ocular higher order aberrations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA


Enrollment: 0
Study Start Date: May 2011
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wavefront-guided LASIK
One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK.
Procedure: Laser in situ keratomileusis (LASIK)
Wavefront guided treatment in one eye, conventional in the other.
Other Names:
  • Device: Carl Zeiss Meditec Visumax femtosecond LASIK
  • Device: Carl Zeiss Meditec MEL-80 excimer laser.
Active Comparator: Conventional LASIK
One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment.
Procedure: Laser in situ keratomileusis (LASIK)
Wavefront guided treatment in one eye, conventional in the other.
Other Names:
  • Device: Carl Zeiss Meditec Visumax femtosecond LASIK
  • Device: Carl Zeiss Meditec MEL-80 excimer laser.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 to 50 years
  • No known ocular or systemic disease
  • Not pregnant or breastfeeding
  • Myopia between -6.0 and -10.0 diopters
  • Astigmatism below 2.0 diopters
  • Difference of less than 1.0 diopters in spherical equivalent between eyes
  • Normal corneal topography
  • Corneal thickness sufficient for planned treatment

Exclusion Criteria:

  • Patients that do not fulfill inclusion criteria
  • Insufficient quality of ocular wavefront measurement
  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: NCT01682434

Locations
Denmark
Department of Ophthalmology, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Anders Ivarsen, MD, PhD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Anders Ivarsen, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01682434     History of Changes
Other Study ID Numbers: AUH_LASIK
Study First Received: September 4, 2012
Last Updated: April 30, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 29, 2014