PURPOSE: To compare the clinical outcome of on-flap and off-flap epi-LASIK for moderate to high myopia. METHODS: This prospective, observer-masked, randomized study included 62 eyes of 31 patients with myopia who underwent off-flap epi-LASIK (epikeratome; Moria, Antony, France) in one eye (off-flap group) and on-flap epi-LASIK in the contralateral eye (on-flap group). Corneal ablation was performed with a commercially available laser (Mel-80; Carl Zeiss Meditec, Oberkochen, Germany). Patients were seen at 3, 5, and 12 days and 1 and 3 months after surgery. Clinical outcomes were compared between groups. RESULTS: No significant between-group differences in the mean preoperative spherical equivalent (-6.18 +/- 1.29 D vs. -6.47 +/- 1.70 D), the change in lines of best corrected visual acuity at 3 months after surgery, and postoperative pain were found. Compared with the on-flap group, outcomes of better uncorrected visual acuity at 3 and 5 days after surgery (P < 0.001), rapider reepithelialization (P < 0.001), and lower level of haze at 1 and 3 months after surgery (P = 0.04, 0.04) were found in the off-flap group. Three months after surgery, contrast sensitivity function (CSF), with and without glare, did not differ from before surgery in both groups (P > 0.05) except CSF at 18 cpd with glare increased significantly in the off-flap group 3 months after surgery (P = 0.04). Wavefront aberration increased significantly from baseline in both groups 3 months after surgery (P < 0.05). The on-flap group revealed greater but insignificant increasing amplitude in wavefront aberration compared with the off-flap group. CONCLUSIONS: In comparison with on-flap epi-LASIK, off-flap epi-LASIK offers comparable postoperative pain, a lower level of haze formation, a rapider visual recovery, and better visual quality. Further investigations of a larger number of subjects and longer follow-up periods are warranted.
RCT Entities:
PURPOSE: To compare the clinical outcome of on-flap and off-flap epi-LASIK for moderate to high myopia. METHODS: This prospective, observer-masked, randomized study included 62 eyes of 31 patients with myopia who underwent off-flap epi-LASIK (epikeratome; Moria, Antony, France) in one eye (off-flap group) and on-flap epi-LASIK in the contralateral eye (on-flap group). Corneal ablation was performed with a commercially available laser (Mel-80; Carl Zeiss Meditec, Oberkochen, Germany). Patients were seen at 3, 5, and 12 days and 1 and 3 months after surgery. Clinical outcomes were compared between groups. RESULTS: No significant between-group differences in the mean preoperative spherical equivalent (-6.18 +/- 1.29 D vs. -6.47 +/- 1.70 D), the change in lines of best corrected visual acuity at 3 months after surgery, and postoperative pain were found. Compared with the on-flap group, outcomes of better uncorrected visual acuity at 3 and 5 days after surgery (P < 0.001), rapider reepithelialization (P < 0.001), and lower level of haze at 1 and 3 months after surgery (P = 0.04, 0.04) were found in the off-flap group. Three months after surgery, contrast sensitivity function (CSF), with and without glare, did not differ from before surgery in both groups (P > 0.05) except CSF at 18 cpd with glare increased significantly in the off-flap group 3 months after surgery (P = 0.04). Wavefront aberration increased significantly from baseline in both groups 3 months after surgery (P < 0.05). The on-flap group revealed greater but insignificant increasing amplitude in wavefront aberration compared with the off-flap group. CONCLUSIONS: In comparison with on-flap epi-LASIK, off-flap epi-LASIK offers comparable postoperative pain, a lower level of haze formation, a rapider visual recovery, and better visual quality. Further investigations of a larger number of subjects and longer follow-up periods are warranted.