Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia
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| First Received Date ICMJE | June 30, 2006 | ||||||||
| Last Updated Date | October 23, 2006 | ||||||||
| Start Date ICMJE | November 2002 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Comparing the efficacy, predictability, stability and safety of LASIK versus PRK | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00348049 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia | ||||||||
| Official Title ICMJE | A Prospective, Randomized Trial Evaluating the Operational Efficacy of LASIK vs. PRK for the Correction of Low and Moderate Myopia in the Singapore Armed Forces | ||||||||
| Brief Summary | Laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) are currently the 2 main refractive surgeries to correct myopia which are being performed worldwide, with more patients preferring LASIK to PRK because of better comfort and faster rehabilitation. However, in post-LASIK patients, there is a low risk of flap dislodgement. This risk increases with certain occupations which have a higher risk of trauma. Hence, there may be a role for PRK for people which such occupations, e.g. soldiers, parachutists, sportsman. There are several non-randomised studies which show that PRK is as efficacious, predictable and safe as LASIK for low to moderate myopes. But there have been only a few randomized controlled studies to compare the efficacy and safety of the 2 treatment modalities and all studies comparing LASIK and PRK suffer from a high dropout rate during the follow-up period. We compared the efficacy, predictability, stability and safety of LASIK versus PRK over a one year duration with almost 100% attendance during all follow-up visits. |
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| Detailed Description | This study is a prospective, randomized, clinical trial comparing the efficacy, predictability, stability and safety of LASIK versus PRK in a volunteer group of myopic military servicemen recruited from the Singapore Armed Forces. 132 subjects who were eligible for the study were randomized to undergo either LASIK or PRK in both eyes in a 2:1 ratio. 45 subjects (90 eyes) underwent PRK and 87 subjects (174 eyes) underwent LASIK. An additional 59 subject underwent a non-randomised arm of the study and underwent PRK. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Myopia | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| 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 | Completed | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | August 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Singapore | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00348049 | ||||||||
| Other Study ID Numbers ICMJE | R277/21/2002 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Singapore National Eye Centre | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Singapore National Eye Centre | ||||||||
| Verification Date | October 2002 | ||||||||
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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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