Comparison of clinical effects between bromfenac sodium versus glucocorticoid following LASIK / 中华实验眼科杂志

ABSTRACT

Background Laser in-situ keratomileusis (LASIK) has been widely used to correct myopia,and the glucocorticoid-induced complication is increased.Bromfenac sodium 0.1％ is a non-steroidal anti-inflammatory drug used post-LASIK,but if it is better in clinical effects,safety and tolerance than glucocorticoid is unclear.Objective This study was to evaluate the safety,effectiveness,compliance of bromfenac sodium ophthalmic solution compared with glucocortieoid following LASIK.Methods A prospective randomized controlled trail were performed.Two hundred thirty-eight myopic eyes of 119 patients for LASIK were included in Peking Union Medical College Hospital from January 2011 to May 2012.The myopic eyes were firstly assigned to moderate and low spherical equivalent (SE) group (≤-6.0 D) or high SE group(＞-6.0 D) and then were further randomized into a NSAIDs subgroup and a glucocorticoid subgroup.Bromfenac sodium ophthalmic solution 0.1％ was topically administered 4 times per day for 10 days in the NSAIDs subgroup,and 0.1％ dexamethasone eye drops was used in the same way in the glucocorticoid subgroup after the LASIK.Uncorrected visual acuity (UCVA),best corrected visual acuity (BCVA),intraocular pressure (IOP),corneal topography,clinical symptom were examined and compared between the groups 1 day,10 days,1 month,3 months and 6 months after LASIK.Results There was no statistically significant postoperative difference in visual acuity and corneal topography (K1,K2,surface asymmetry index [SAI],surface regular index [SRI] and cylinder) between the NSAIDs and control group (P＞0.05).Postoperative IOP was significantly lower than that in preoperation,and lower IOP was found in the NSAIDs group than that of the glucocorticoid group.The IOP values in the moderate and low SE subjects of the NSAIDs group and glucocorticoid group were (13.31±2.44) mmHg and (16.62±4.74) mmHg on postoperative 10 days,(12.93±2.25) mmHg and (12.82± 1.72) mmHg in 1 month,(13.83±3.08) mmHg and (13.33 ±2.10) mmHg in 3 months,(11.67 ±2.48) mmHg and (13.64± 1.37)mmHg in 6 months after operation,respectively,showing significant differences among the groups and various timepoints (Fgroup =4.067,P =0.045 ; Ftime =10.689,P =0.000 ; Finteraction =2.897,P =0.023).In the high SE subjects of the NSAIDs and glucocorticoid group,the IOP values were (12.36± 1.30) mmHg and (17.32±4.74) mmHg in postoperative 10 days,(12.10t2.12)mmHg and (14.81 ±2.26)mmHg in postoperative I month,with a significant difference among the groups and timepoints (Fgroup =2.188,P =0.121 ;Ftime =14.025,P =0.000 ;Fi tion =15.805,P=0.000).No haze or diffuse lamellar keratitis (DLK) appeared in both groups,and the epithelial flaps were wellpositioned with satisfying healing process except for one eye in the moderate and low SE eyes of the NSAIDs group.Bromfenac sodium ophthalmic solution 0.1％ was well tolerated by all patients in the NSAIDs group,but discontinuation sensation occurred in 8 eyes of 6 patients and the antiglaucoma drugs were administered due to elevated IOP in the glucocorticoid group.The refractive status remained stable for patients of the moderate and low SE group.Conclusions Bromfenac sodium ophthalmic solution 0.1％ is safe,effective and well tolerated after topically administered following LASIK,and its outcomes in recovery of visual acuity,anti-inflammation and stabilizing refractive status and IOP are satisfying.But long-term attention should be payed to the high-myopic eyes.