Purpose: To examine possible differences in efficacy and safety between LASIK and photorefractive keratectomy (PRK) for correction of myopia.
Design: Meta-analysis/systematic review.
Participants: Patient data from previously reported prospective randomized controlled trials (PRCTs) and a systematic review of prospective case series in the Food and Drug Administration (FDA) clinical trials database.
Methods: A comprehensive literature search was performed using the Cochrane Collaboration methodology to identify PRCTs comparing LASIK and PRK for correction of myopia. A meta-analysis was performed on the results of PRCTs. In parallel, a systematic review of prospective data from FDA case series of LASIK and PRK for correction of myopia was undertaken.
Main outcome measures: Key efficacy outcomes (uncorrected visual acuity [UCVA] > or = 20/20, +/-0.50 diopters [D] of the target mean refractive spherical equivalent) and safety outcomes (loss of > or =2 lines of best spectacle-corrected visual acuity [BSCVA], final BSCVA > or = 20/40, and final BSCVA < 20/25 where preoperative BSCVA was > or =20/20).
Results: Seven PRCTs were identified comparing PRK (683 eyes) and LASIK (403 eyes) for correction of myopia. More LASIK patients achieved UCVA > or = 20/20 at 6 months (odds ratio, random effects model [95% confidence interval], 1.72 [1.14-2.58]; P = 0.009) and 12 months (1.78 [1.15-2.75], P = 0.01). Loss of > or =2 lines of BSCVA at 6 months was less frequent with LASIK (2.69 [1.01-7.18], P = 0.05). Data from 14 LASIK (7810 eyes) and 10 PRK (4414 eyes) FDA laser approval case series showed that more LASIK patients achieved UCVA of 20/20 or better at 12 months (1.15 [1.03-1.29], P = 0.01), significantly more LASIK patients were within +/-0.50 D of target refraction at 6 months (1.38 [1.26-1.50], P<0.00001) and 12 months (1.21 [1.08-1.36], P = 0.0009) after treatment, and loss of > or =2 lines of BSCVA at 6 months was less frequent with LASIK (2.91 [2.22-3.83], P<0.00001).
Conclusions: LASIK appears to have efficacy and safety superior to those of PRK. However, the data examined are from studies conducted > or =5 years ago. It is therefore unclear how our findings relate to present-day methods and outcomes. Further trials comparing contemporary equipment and techniques are needed to reevaluate the relative merits of these procedures.