Surgical Correction of Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01680354
Recruitment Status : Withdrawn (Institution changed surgical method to small incision lenticule extraction. Study never started.)
First Posted : September 7, 2012
Last Update Posted : May 2, 2014
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital

September 4, 2012
September 7, 2012
May 2, 2014
September 2012
September 2012   (Final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01680354 on Archive Site
Refraction [ Time Frame: 1 year ]
Same as current
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Surgical Correction of Astigmatism
Comparative Study of Surgical Laser Correction of Astigmatism

Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.

During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.

In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.

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Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: ReLEx
    Other Name: Device: Carl Zeiss Meditec Visumax Femtosecond Laser
  • Procedure: LASIK
    Other Name: Device: Carl Zeiss Meditec MEL-80 excimer laser
  • Active Comparator: ReLEx
    One eye is treated with ReLEx the other with LASIK
    Intervention: Procedure: ReLEx
  • Active Comparator: LASIK
    One eye is treated with ReLEx the other with LASIK
    Intervention: Procedure: LASIK
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Myopic astigmatism between -2.0 and -5.0 diopters
  • Maximal difference in spherical equivalent refraction of 2 D between eyes
  • No ocular or systemic disease
  • Not pregnant or breastfeeding
  • Minimum BSCVA of 0.8 (decimal)
  • Normal corneal topography
  • Sufficient corneal thickness to allow the treatment

Exclusion Criteria:

  • Subjects not fulfilling the above criteria
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Anders Ivarsen, Aarhus University Hospital
Aarhus University Hospital
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Not Provided
Aarhus University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP