Clinical effect evaluation of the early stage on correcting of myopia by corneal small incision lenticule extraction

Abstract

Objective To evaluate the safety, efficacy, predictability and stability of femtosecond laser corneal small incision lenticule extraction (SMILE) procedure for the correction of myopia. Methods In this prospective study, 70 patients (137 eyes) with myopia were chosen to be performed SMILE procedure randomly from September 2014 to January 2015 at Department of Ophthalmology, Wuhan General Hospital of Guangzhou Military Command. The average age of the patients was 23.73±4.51 years (ranged 18 to37 years). The mean SE was (-6.20±1.37) diopters (D) preoperatively, from -1. 63 to -9.25 D. All patients took measurements of uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), spherical equivalent (SE) in 6 months postoperatively. Results The UCVA gradually increased after surgery, the UCVA was 5.09±0.08 at 6 months postoperatively; 135 eyes (98.54%) had a UCVA of 4.9 or better, 133 eyes (97.08%) had a UCVA of 5.0 or better, and 96 eyes (70.07%) had a UCVA of 5.1 or better. The BCVA at 3 and 6 months postoperatively were better than the BCVA preoperatively. At 6 months postoperatively, 61 eyes (44.53%) had BCVA equal to the preoperative, 63 eyes (45.99%) gained one line and 3 eyes (2.19%) gained two or more lines of BCVA, 10 eyes (7.30%) lost one line of BCVA, on one lost two or more lines of BCVA. The mean postoperative SE was (0.00±0.45)D, (-0.04±0.52)D, (0.02±0.48)D at 1 month, 3 and 6 months postoperatively respectively, there was no significant difference was found at the different time (F=1.02, P=0.36). At 6 months, 105 eyes (76.64%) and 134 eyes (97.81%) were within±0.50 and ±1.00 D of the attempted correction. There were several complications during the operation, such as black spot, opaque bubble layer, incision offset, incision bleeding, incision laceration, and lenticular rupture. Two eyes had mild diffuse lamellar keratitis at the early stage postoperatively. All complications were treated in time effective. Conclusions The SMILE is a safe and effective procedure for the treatment of myopia, and has excellent predictability and stability, there was no serious complication. Key words: Small Incision; Lenticule Extraction; Myopia; Clinical effect