OBJECTIVE: This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). DESIGN: A randomized, prospective multicenter clinical trial. PARTICIPANTS: A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. INTERVENTION: All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. MAIN OUTCOME MEASURES: Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. RESULTS: One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity < 20/40 for PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more (odds ratio = 3.89 for risk of loss of spectacle-corrected visual acuity for PRK vs. LASIK, 95% CI = 0.71-21.30). Only two eyes had postoperative spectacle-corrected visual acuity less than 20/32, however. CONCLUSIONS: Although improvement in uncorrected visual acuity is more rapid in LASIK than in PRK, efficacy outcomes in the longer term generally are similar between the two procedures. There is a greater tendency toward undercorrection in LASIK eyes using the specific laser and nomogram in this study, but the scatter in achieved versus attempted correction is similar, suggesting little difference in the accuracy of the two procedures. A suggestion of decreased propensity for loss of spectacle-corrected visual acuity in LASIK eyes requires further investigation.
RCT Entities:
OBJECTIVE: This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). DESIGN: A randomized, prospective multicenter clinical trial. PARTICIPANTS: A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. INTERVENTION: All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. MAIN OUTCOME MEASURES: Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. RESULTS: One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity < 20/40 for PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more (odds ratio = 3.89 for risk of loss of spectacle-corrected visual acuity for PRK vs. LASIK, 95% CI = 0.71-21.30). Only two eyes had postoperative spectacle-corrected visual acuity less than 20/32, however. CONCLUSIONS: Although improvement in uncorrected visual acuity is more rapid in LASIK than in PRK, efficacy outcomes in the longer term generally are similar between the two procedures. There is a greater tendency toward undercorrection in LASIK eyes using the specific laser and nomogram in this study, but the scatter in achieved versus attempted correction is similar, suggesting little difference in the accuracy of the two procedures. A suggestion of decreased propensity for loss of spectacle-corrected visual acuity in LASIK eyes requires further investigation.