Surgical Correction of Astigmatism
This study is currently recruiting participants.
Verified September 2012 by Aarhus University Hospital
Sponsor:
Aarhus University Hospital
Information provided by (Responsible Party):
Anders Ivarsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01680354
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 4, 2012 | ||||
| Last Updated Date | September 6, 2012 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01680354 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Surgical Correction of Astigmatism | ||||
| Official Title ICMJE | Comparative Study of Surgical Laser Correction of Astigmatism | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Astigmatism | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01680354 | ||||
| Other Study ID Numbers ICMJE | AUH_ASTIGMATISM | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anders Ivarsen, Aarhus University Hospital | ||||
| Study Sponsor ICMJE | Aarhus University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Aarhus University Hospital | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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