NCT00348049

Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Singapore National Eye Centre · Other Government
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Myopia

Interventions

Type	Name	Description
PROCEDURE	Laser in Situ Keratomileusis (LASIK)
PROCEDURE	Photorefractive Keratectomy (PRK)

Timeline

• Start date: 2002-11-01
• Completion: 2005-08-01
• First posted: 2006-07-04
• Last updated: 2006-10-24

Locations

1 site across 1 country: Singapore