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Surgical Correction of Astigmatism

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Institution changed surgical method to small incision lenticule extraction.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

Brief Summary:

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.

Condition or disease Intervention/treatment
Astigmatism Procedure: ReLEx Procedure: LASIK

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Surgical Laser Correction of Astigmatism
Study Start Date : September 2012
Estimated Primary Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: ReLEx
One eye is treated with ReLEx the other with LASIK
Procedure: ReLEx
Other Name: Device: Carl Zeiss Meditec Visumax Femtosecond Laser
Active Comparator: LASIK
One eye is treated with ReLEx the other with LASIK
Procedure: LASIK
Other Name: Device: Carl Zeiss Meditec MEL-80 excimer laser

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Refraction [ Time Frame: 1 year ]

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680354

Department of Ophthalmology, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital

Responsible Party: Anders Ivarsen, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01680354     History of Changes
Other Study ID Numbers: AUH_ASTIGMATISM
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases