Research question
How does laser-assisted subepithelial keratectomy compare with photorefractive keratectomy for eyes with myopia?
Background
Myopia (short-sightedness or near-sightedness) is a condition whereby people cannot see distant objects clearly. The prevalence of myopia is increasing worldwide, especially in some Asian areas. Spectacles and contact lenses are commonly used for correction of this condition. Surgical procedures such as laser-assisted subepithelial keratectomy (LASEK) and photorefractive keratectomy (PRK) also can be used for correction of myopia. In both procedures, a laser is used to remove corneal tissue (front of the eye); these procedures have been performed in human eyes for nearly 30 years.
Study characteristics
We identified 11 trials that enrolled 428 adult participants. These trials were conducted in various countries, including the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Ten out of 11 trials used a paired-eye design, in which one eye of each participant received LASEK and the other eye received PRK. The remaining trial included one eye of six participants and both eyes of 15 participants. Most participants included in the trials had low to moderate myopia. The evidence is current as of 15 December 2015.
Key results
Because these trials reported different outcomes at different time points, it is difficult to compare the effectiveness of LASEK versus PRK across trials. We assessed our primary outcomes 12 months after the surgeries were performed. Available data were insufficient to clarify whether LASEK performed better than PRK with respect to correcting visual acuity to 20/20 or better, achieving within 0.50 diopters of target refraction, or preventing loss of corrected visual acuity. Data were insufficient for assessment of whether differences between procedures in adverse outcomes occurred at 12 months after the surgeries. At 24 months post treatment, one trial reported that eyes treated LASEK with may have better corneal haze scores than those treated with PRK, but that the difference may not be noticeable.
Quality of the evidence
Available data were insufficient for investigation of whether LASEK or PRK is better at correcting near-sightedness. We judged the evidence for most outcomes as very low to moderate quality because of variation in reporting and differences in effects among trials.
Uncertainty surrounds differences in efficacy, accuracy, safety, and adverse effects between LASEK and PRK for eyes with low to moderate myopia. Future trials comparing LASEK versus PRK should follow reporting standards and follow correct analysis. Trial investigators should expand enrollment criteria to include participants with high myopia and should evaluate visual acuity, refraction, epithelial healing time, pain scores, and adverse events.
Myopia (near-sightedness or short-sightedness) is a condition in which the refractive power of the eye is greater than required. The most frequent complaint of people with myopia is blurred distance vision, which can be eliminated by conventional optical aids such as spectacles or contact lenses, or by refractive surgery procedures such as photorefractive keratectomy (PRK) and laser epithelial keratomileusis (LASEK). PRK uses laser to remove the corneal stroma. Similar to PRK, LASEK first creates an epithelial flap and then replaces it after ablating the corneal stroma. The relative benefits and harms of LASEK and PRK, as shown in different trials, warrant a systematic review.
The objective of this review is to compare LASEK versus PRK for correction of myopia by evaluating their efficacy and safety in terms of postoperative uncorrected visual acuity, residual refractive error, and associated complications.
We searched CENTRAL (which contains the Cochrane Eyes and Vision group Trials Register) (2015 Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 December 2015. We used the Science Citation Index and searched the reference lists of the included trials to identify relevant trials for this review.
We included in this review randomized controlled trials (RCTs) comparing LASEK versus PRK for correction of myopia. Trial participants were 18 years of age or older and had no co-existing ocular or systemic diseases that might affect refractive status or wound healing.
Two review authors independently screened all reports and assessed the risk of bias of trials included in this review. We extracted data and summarized findings using risk ratios and mean differences. We used a random-effects model when we identified at least three trials, and we used a fixed-effect model when we found fewer than three trials.
We included 11 RCTs with a total of 428 participants 18 years of age or older with low to moderate myopia. These trials were conducted in the Czech Republic, Brazil, Italy, Iran, China, Korea, Mexico, Turkey, USA, and UK. Investigators of 10 out of 11 trials randomly assigned one eye of each participant to be treated with LASEK and the other with PRK, but did not perform paired-eye (matched) analysis. Because of differences in outcome measures and follow-up times among the included trials, few trials contributed data for many of the outcomes we analyzed for this review. Overall, we judged RCTs to be at unclear risk of bias due to poor reporting; however, because of imprecision, inconsistency, and potential reporting bias, we graded the quality of the evidence from very low to moderate for outcomes assessed in this review.
The proportion of eyes with uncorrected visual acuity of 20/20 or better at 12-month follow-up was comparable in LASEK and PRK groups (risk ratio (RR) 0.98, 95% confidence interval (95% CI) 0.92 to 1.05). Although the 95% CI suggests little to no difference in effect between groups, we judged the quality of the evidence to be low because only one trial reported this outcome (102 eyes). At 12 months post treatment, data from two trials suggest no difference or a possibly small effect in favor of PRK over LASEK for the proportion of eyes achieving ± 0.50 D of target refraction (RR 0.93, 95% CI 00.84 to 1.03; 152 eyes; low-quality evidence). At 12 months post treatment, one trial reported that one of 51 eyes in the LASEK group lost one line or more best-spectacle corrected visual acuity compared with none of 51 eyes in the PRK group (RR 3.00, 95% CI 0.13 to 71.96; very low-quality evidence).
Three trials reported adverse outcomes at 12 months of follow-up or longer. At 12 months post treatment, three trials reported corneal haze score; however, data were insufficient and were inconsistent among the trials, precluding meta-analysis. One trial reported little or no difference in corneal haze scores between groups; another trial reported that corneal haze scores were lower in the LASEK group than in the PRK group; and one trial did not report analyzable data to estimate a treatment effect. At 24 months post treatment, one trial reported a lower, but clinically unimportant, difference in corneal haze score for LASEK compared with PRK (MD -0.22, 95% CI -0.30 to -0.14; 184 eyes; low-quality evidence).