Suleiman Yusuf M, Krdoghli Najwa F, Ahmad Aksam J
Department of Ophthalmology, Al-Assad Hospital, Tishreen University, Latakia, Syria.
Sultan Qaboos Univ Med J. 2010 Apr;10(1):57-63. Epub 2010 Apr 17.
The aim of this study was to compare the efficacy and safety of topical prednisolone acetate 1% and topical ketorolac tromethamine 0.5% in the maintenance of pupillary mydriasis during cataract surgery.
Fifty patients were enrolled in this prospective, partially masked and randomised study. They were assigned to receive topical treatment with either prednisolone acetate (n = 25) or ketorolac tromethamine (n = 25), starting 24 hours before cataract extraction (either routine extracapsular cataract extraction or phacoemulsification). One drop of the study medication was instilled every 6 hours for a total of 4 drops. No epinephrine was used in the intraoperative irrigation solution. Pupil diameter was measured three different times during surgery. To ensure participant safety, biomicroscopy, ophthalmoscopy, intraocular pressure, adverse events and visual acuity were also monitored.
The mean pupil diameter change from the time of the pre-incision until after cortical irrigation and aspiration and lens implantation was significantly less with ketorolac than with prednisolone (P = 0.003). Consequently, mean pupil diameter after cortical irrigation and aspiration and lens implantation was significantly greater with ketorolac than with prednisolone (P <0.0001). No significant differences between groups were observed in the pupil diameter before the first incision (P = 0.244), nor after administration of a miotic agent (P = 0.505). Safety variables were comparable and no drug-related adverse events were reported.
Ketorolac tromethamine 0.5% and prednisolone acetate 1% solutions were equally well tolerated without related adverse events, but ketorolac was better in preventing surgically induced miosis.
本研究旨在比较1%醋酸泼尼松龙滴眼液与0.5%酮咯酸氨丁三醇滴眼液在白内障手术中维持瞳孔散大的疗效及安全性。
50例患者纳入这项前瞻性、部分设盲的随机研究。患者被分配接受醋酸泼尼松龙(n = 25)或酮咯酸氨丁三醇(n = 25)局部治疗,于白内障摘除术前24小时开始(常规囊外白内障摘除术或超声乳化白内障吸除术)。每6小时滴入一滴研究药物,共4滴。术中冲洗液未使用肾上腺素。手术期间在三个不同时间测量瞳孔直径。为确保参与者安全,还监测了生物显微镜检查、检眼镜检查、眼压、不良事件及视力。
从切口前至皮质冲洗吸出及晶状体植入后,酮咯酸组的平均瞳孔直径变化明显小于醋酸泼尼松龙组(P = 0.003)。因此,皮质冲洗吸出及晶状体植入后,酮咯酸组的平均瞳孔直径明显大于醋酸泼尼松龙组(P <0.0001)。两组在首次切口前的瞳孔直径(P = 0.244)及使用缩瞳剂后(P = 0.505)均未观察到显著差异。安全变量具有可比性,未报告与药物相关的不良事件。
0.5%酮咯酸氨丁三醇溶液和1%醋酸泼尼松龙溶液耐受性相当,均无相关不良事件,但酮咯酸在预防手术引起的瞳孔缩小方面效果更佳。