Comparison of clinical effects between bromfenac sodium versus loteprednol etabonate following FS-LASIK

Objective

To compare the efficacy, safety and tolerability between bromfenac sodium ophthalmic solution 0.1% eye drop and loteprednol etabonate 0.5% eye drop after femtosecond laser in situ keratomileusis (FS-LASIK).

Methods

A prospective randomized controlled trail was performed.Seventy-six patients who had been undergone FS-LASIK in Daping Hospital were enrolled from December 2013 to December 2014.They were divided into two groups randomly by using the random number table method.The bromfenac sodium group included 38 patients administered 0.1% bromfenac sodium ophthalmic solution, and the loteprednol etabonate group comprised 38 patients treated with 0.5% loteprednol etabonate.Patients in both groups initially administered tobramycin-dexamethasone four times a day after FS-LASIK for 1 week.Then the patients in the bromfenac sodium group were treated with bromfenac sodium twice a day until 1 month postoperatively.While the patients from the loteprednol etabonate group were treated with loteprednol etabonate twice a day until 1 month after surgery.Visual acuity, refraction, intraocular pressure and ocular manifestation were examined preoperative and 1 day, 1 week, 1 month, 3 months, 6 months after FS-LASIK.This study was approved by the medical ethics Committee of Daping Hospital.

Results

No significant difference was found in the rate of uncorrected visual acuity (UCVA) which achieved to preoperative best corrected visual acuity (BCVA) between the two groups at each time point after operation (χ²=8.000, P=0.613). There was no difference in spherical equivalent (SE) between the two groups postoperatively (F_group=1.137, P=0.288), but a significant difference was found between the different time points (F_time=29.771, P=0.000). Postoperative SE in the two groups tended to have mild hyperopia in the early days, and then gradually tended to “zero” or mild myopia.There was a significant difference with intraocular pressure among different time points (F_time=87.519, P=0.000), but no significant difference of intraocular pressure was found between the groups (F_group=1.989, P=0.161). One month after surgery, the intraocular pressure were higher than 20 mmHg in two eyes in the loteprednol etabonate group, and two eyes were 5 mmHg higher than preoperative intraocular pressure.In bromfenac group, no one was higher than 5 mmHg compared with the preoperative intraocular pressure, and the pressures of all the eyes were lower than 18 mmHg.All the patients in bromfenac group were no drug withdrawal.But three patients were forced to guide drug withdrawal due to high intraocular pressure in loteprednol group.

Conclusions

Bromfenac sodium is safe, effective and well tolerated after FS-LASIK.