Comparison of the Clinical Effects of Bromfenac Sodium and Fluorometholone after LASEK Surgery

Abstract

Objective: To compare the effectiveness of bromfenac sodium and fluorometholone eye drops on relieving corneal irritation and its safety in clinical applications after laser epithelial keratomileusis (LASEK) surgery. Methods: This was a prospective randomized, controlled study. A total of 60 patients (120 eyes) who underwent LASEK surgery from April 2017 to February 2018 in Tianjin Eye Hosptial were divided randomly into a bromfenac sodium group and a fluorometholone group according to the random number table, 30 patients (60 eyes) were included in each group. In the first week after the surgery, the bromfenac sodium group was given 0.1% bromfenac sodium eye drops twice a day, and then from the second week, this eye drops changed to 4 times per day for 1 month and 2 times per day in the following month. While the fluorometholone group was given 0.3% sodium hyaluronate eye drops twice a day in the first week after the surgery, then the eye drops changed to 0.1% fluorometholone by giving 4 times per day, which was gradually tapered in every month to the end. Corneal irritation and epithelial healing were evaluated at 1 d, 2 d, 3 d and 5 d after surgery. Examinations of uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, slit lamp, Schirmer Ⅰ test (SⅠT), tear film break-up time (BUT) and corneal epithelium integrity evaluation were performed 1 week, 1 month and 3 months after surgery. An intraocular pressure (IOP) examination was performed 1 week, 2 weeks, 1 month, 3 months and 4 months. The data were analyzed by repeated measures ANOVA, independent sample t-test and Mann-Whitney U test. Results: The scores for corneal irritation in the bromfenac sodium group were significantly lower than those in the fluorometholone group after surgery (Fgroups=7.8, P=0.018; Ftimes=121.7, P<0.001; Finteraction=273.4, P<0.001). At 1 month after surgery, the mean visual acuity of both groups recovered to 1.0 or better. There were no statistically significant differences in UCVA, BCVA or refraction between the two groups. At 1 month after surgery, there were 6 cases (10%) of corneal haze in the bromfenac sodium group while there were 2 cases (3%) in the fluorometholone group. The correction of IOP in the bromfenac sodium group after surgery were all below 21 mmHg, while there were 5 cases (9%) of high IOP at 2 weeks and 3 cases (5%) at 1 month in the fluorometholone group. After 3 months, both SⅠT and BUT in the two groups returned to normal levels, and the difference was not statistically significant. After 3 months, the corneal epithelium had totally recovered in most of the patients in the two groups. There was no statistically significant difference between the two groups. Conclusions: Bromfenac sodium eye drops can effectively alleviate corneal irritation after LASEK surgery. It is safe and effective for the recovery of vision and anti-inflammatory effects. Furthermore, bromfenac sodium can reduce the risk of postoperative high intraocular pressure caused by glucocorticoids. However, the incidence of corneal haze is slightly higher. Key words: bromfenac sodium; non-steroid anti-inflammatory drugs; glucocorticoids; laser epithelial keratomileusis; steroid-induced glaucoma