- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404105
A Comparison of PRK and LASIK for Correction of Myopia
November 24, 2006 updated by: University of Aarhus
A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia
The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.
Study Overview
Study Type
Interventional
Enrollment
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus C, Denmark, 8000
- Department of Ophthalmology, Aarhus Sygehus NBG
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- spherical equivalent subjective refraction between -6.00 and -8.00 diopters
- age between 18 and 49 years
- desire for having laser refractive surgery
Exclusion Criteria:
- present or past eye disease excluding myopia
- pregnant or lactating woman
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Uncorrected visual acuity
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Best corrected visual acuity
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Best spectacle correction
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Secondary Outcome Measures
Outcome Measure |
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IOP
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Corneal thickness
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Corneal wavefront aberrations
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jesper Hjortdal, MD, PhD, Department of Ophthalmology, Aarhus Sygehus, University of Aarhus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Study Completion
May 1, 2004
Study Registration Dates
First Submitted
November 24, 2006
First Submitted That Met QC Criteria
November 24, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Estimate)
November 27, 2006
Last Update Submitted That Met QC Criteria
November 24, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUH-Ophthalmology-1999-01
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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