Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia
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|ClinicalTrials.gov Identifier: NCT00348049|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 24, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Procedure: Laser in Situ Keratomileusis (LASIK) Procedure: Photorefractive Keratectomy (PRK)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||November 2002|
|Study Completion Date :||August 2005|
- Comparing the efficacy, predictability, stability and safety of LASIK versus PRK
- Comparing wavefront aberrometry of LASIK vs PRK
- Comparing patient satisfaction of LASIK vs PRK
- Comparing effects of LASIK vs PRK in terms of post-surgery performance in the military setting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348049
|Singapore Eye Research Institute|
|Singapore, Singapore, 168751|
|Principal Investigator:||Donald Tan, FAMS||Singapore Eye Research Institute|
|Principal Investigator:||Benjamin Seet||Singapore Armed Forces|