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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Astigmatism
Procedure: ReLEx
Procedure: LASIK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Surgical Laser Correction of Astigmatism

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT01680354

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

No publications provided

Responsible Party: Anders Ivarsen, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01680354     History of Changes
Other Study ID Numbers: AUH_ASTIGMATISM
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:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014