A randomized-controlled clinical trial on the application of 0.5％ Ioteprednol etabonate eye drops after myopic laser-assisted in situ keratomileusis surgery / 中华实验眼科杂志

ABSTRACT

Background It has become a consensus about the necessity of topical administration of corticosteroid eye solutions after myopic laser-assisted in situ keratomileusis(LASIK).The glucocorticoid eye drops with good anti-inflammatory effect and less adverse effects is helpful for the repair of corneal epithelium following LASIK.Objective This study was to evaluate the clinical effects of 0.5％ loteprednol etabonate eye drops after LASIK.Methods A prospective randomized-controlled study was designed.One hundred and twelve myopia patients(224 eyes)who had received LASIK were included in this study and randomly divided into two groups,and 97 patients finished the follow-up,including 108 eyes of 54 patients in the 0.5％ ioteprednol etabonate eye drops treatment group and 86 eyes of 43 patients in the control group.0.5％ loteprednol etabonate eye drops or dexamethasone/tobramycin eye drops were administered topically to the treatment group and control group,respectively 4 times daily from postoperative day 1 through day 7 following LASIK in addition to regular basic treatment.The follow-up was performed 1 day,1 week and 1 month after LASIK.Subjective symptoms including eye pain,foreign body sensation and blurring were scored,and uncorrected visual acuity(UCVA),best corrected visual acuity(BCVA),intraocular pressure(IOP),central corneal thickness,corneal fluorescein staining and diffuse laminar keratitis(DLK)were evaluated and compared between the two groups 1 day,1 week,and 1 month after LASIK.This clinical trial was approved by the Ethic Commission of Zhongshan Ophthalmic Center,and written informed consent was obtained from each patient before the trial.Results No drug-related ocular and systemic adverse events were found in the treatment group throughout the follow-up duration.There was no significant difference in the subjective symptom score after 1 day,1 week and 1 month(P＞0.05).At 1 week post-LASIK,the corrected actual IOP was (16.27±3.31)mmHg in the treatment group and(17.49±4.48)mmHg in the control group,with a statistically significant difference between them(t =-2.113,P =0.036).However,there was no statistically significant difference in IOP between the treatment group(15.01±3.22)mmHg and the control group(15.30±4.17)mmHg at 1 month post-LASIK(t=-0.532,P=0.595).Mild diffuse lamellar keratitis developed in 7 eyes in the treatment group and 5 eyes in the control group without a significant difference on the first day after LASIK(x2 =0.153,P =0.926).The scores of corneal fluorescein staining were not statistically different between the two groups at 1 day,1 week and 1 month postoperative(Z=-0.566,P=0.571 ;Z=-0.689,P=0.491 ;Z=-1.628,P=0.103).Conclusions 0.5％ loteprednol etabonate eye drops could effectively inhibit postoperative inflammation and low the incidence of DLK.It can lessen the risk of IOP elevation in comparison with traditional steroid eye drops.