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NCT01680354 Clinical Trial

Surgical Correction of Astigmatism

Astigmatism Clinical Trial

Official title:
Comparative Study of Surgical Laser Correction of Astigmatism

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01680354
Other study ID # AUH_ASTIGMATISM
Secondary ID
Status Withdrawn
Phase N/A
First received September 4, 2012
Last updated April 30, 2014
Start date September 2012

Study information
Verified date April 2014
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• ReLEx

• LASIK

Locations
Country Name City State
Denmark Department of Ophthalmology, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 1 year Yes
Secondary Refraction 1 year No
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