Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Surgical Correction of Astigmatism

This study has been withdrawn prior to enrollment.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:
NCT01680354
First received: September 4, 2012
Last updated: April 30, 2014
Last verified: April 2014

September 4, 2012
April 30, 2014
September 2012
September 2012   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01680354 on ClinicalTrials.gov Archive Site
Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Astigmatism
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
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
Both
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01680354
AUH_ASTIGMATISM
No
Anders Ivarsen, Aarhus University Hospital
Aarhus University Hospital
Not Provided
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