- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680354
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.
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aarhus, Denmark, DK-8000
- Department of Ophthalmology, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ReLEx
One eye is treated with ReLEx the other with LASIK
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Other Names:
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Active Comparator: LASIK
One eye is treated with ReLEx the other with LASIK
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Refraction
Time Frame: 1 year
|
1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUH_ASTIGMATISM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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