Wavefront-guided LASIK for Correction of Myopia

April 30, 2014 updated by: Anders Ivarsen, Aarhus University Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8000
        • Department of Ophthalmology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular higher order aberrations
Time Frame: 12 months
Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Anders Ivarsen, MD, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUH_LASIK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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