PURPOSE: To compare the efficacy and safety of rimexolone 1% and prednisolone acetate 1% ophthalmic suspensions in controlling intraocular inflammation in the early period after cataract surgery. METHODS:Eighty patients undergoing cataract extraction with intraocular lens implantation, eitherplanned extra capsular cataract extraction (PECCE) or phacoemulsification surgery, were evaluated in a prospective, randomized, observer-masked, clinical trial in which efficacy in controlling early postoperative inflammation and safety of prednisolone acetate 1% one eye drop every 4 h (n = 36 eyes) was compared with that of rimexolone 1% one eye drop every 4 h (n = 44 eyes) in an eighteen day course. Efficacy was assessed from changes of the anterior chamber cell count, flare, conjunctival hyperemia, and ciliary congestion by means of slit lamp biomicroscopy on days 1, 3, 8, 15, and 18. Intraocular pressure (IOP) and possible side effects were also recorded on each visit. RESULTS:Anterior chamber cell count and flare showed no difference in the two groups at any visits. The rimexolone group was associated with significantly higher score for conjunctival hyperemia on days one and three (P < 0.05) and the prednisolone acetate group was associated with a significantly higher score for corneal edema on day 8 (P < 0,05). However, there were no between group differences in IOP. CONCLUSIONS:Rimexolone 1% ophthalmic suspension was as effective and safe as prednisolone acetate 1% ophthalmic suspension in controlling inflammation in the early period after cataract surgery.
RCT Entities:
PURPOSE: To compare the efficacy and safety of rimexolone 1% and prednisolone acetate 1% ophthalmic suspensions in controlling intraocular inflammation in the early period after cataract surgery. METHODS: Eighty patients undergoing cataract extraction with intraocular lens implantation, either planned extra capsular cataract extraction (PECCE) or phacoemulsification surgery, were evaluated in a prospective, randomized, observer-masked, clinical trial in which efficacy in controlling early postoperative inflammation and safety of prednisolone acetate 1% one eye drop every 4 h (n = 36 eyes) was compared with that of rimexolone 1% one eye drop every 4 h (n = 44 eyes) in an eighteen day course. Efficacy was assessed from changes of the anterior chamber cell count, flare, conjunctival hyperemia, and ciliary congestion by means of slit lamp biomicroscopy on days 1, 3, 8, 15, and 18. Intraocular pressure (IOP) and possible side effects were also recorded on each visit. RESULTS: Anterior chamber cell count and flare showed no difference in the two groups at any visits. The rimexolone group was associated with significantly higher score for conjunctival hyperemia on days one and three (P < 0.05) and the prednisolone acetate group was associated with a significantly higher score for corneal edema on day 8 (P < 0,05). However, there were no between group differences in IOP. CONCLUSIONS:Rimexolone 1% ophthalmic suspension was as effective and safe as prednisolone acetate 1% ophthalmic suspension in controlling inflammation in the early period after cataract surgery.
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