Singal Neera, Hopkins Jill
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.
Can J Ophthalmol. 2004 Apr;39(3):245-50. doi: 10.1016/s0008-4182(04)80121-2.
Pseudophakic cystoid macular edema (CME) following phacoemulsification is the most common complication after cataract surgery. Treatment focuses on the reduction of inflammation with topical use of both steroids and NSAIDS. The latter have been shown to be of benefit in chronic CME, but topical NSAID and steroid treatment has only recently been shown to be of benefit in acute CME. We evaluated the use of topically administered NSAIDS and steroids in the management of both acute and chronic pseudophakic CME.
This was a prospective double-masked randomized controlled trial. Patients with clinical CME occurring at least 6 weeks following cataract extraction were referred for consideration of enrolment. Patients were excluded if they had Snellen vision better than 20/40, no CME on clinical examination, no CME on angiography, recent use of steroids, preexisting macular disease or diabetic maculopathy on angiography. Ten patients were randomly assigned to receive either 0.5% ketorolac tromethamine plus placebo (four patients) or 0.5% ketorolac tromethamine plus 1% prednisolone acetate (six patients); all 10 completed the study. Patients were assessed at baseline and at 30, 60 and 90 days. Fluorescein angiography was performed at baseline and at 90 days. The primary outcome measures were improvement in Early Treatment Diabetic Retinopathy Study Snellen equivalent vision and resolution of cysts on clinical examination.
No statistically significant differences were found between the two groups in either of the outcome measures at any visit. Subgroup analysis of the patients with chronic CME also showed no significant difference between the two groups.
We found no statistically significant difference in outcome between patients who received ketorolac and those who received ketorolac plus prednisolone for acute or chronic CME. The value of topical steroid therapy for chronic CME remains unproven.
白内障超声乳化术后的人工晶状体眼黄斑囊样水肿（CME）是白内障手术后最常见的并发症。治疗重点是局部使用类固醇和非甾体抗炎药（NSAIDs）以减轻炎症。后者已被证明对慢性CME有益，但局部使用NSAID和类固醇治疗仅在最近才被证明对急性CME有益。我们评估了局部应用NSAIDs和类固醇在急性和慢性人工晶状体眼CME治疗中的应用。
这是一项前瞻性双盲随机对照试验。白内障摘除术后至少6周出现临床CME的患者被转诊考虑入组。如果患者的Snellen视力优于20/40、临床检查无CME、血管造影无CME、近期使用过类固醇、存在黄斑疾病或血管造影显示有糖尿病性黄斑病变，则将其排除。10名患者被随机分配接受0.5%酮咯酸氨丁三醇加安慰剂（4名患者）或0.5%酮咯酸氨丁三醇加1%醋酸泼尼松龙（6名患者）；所有10名患者均完成了研究。在基线以及第30、60和90天对患者进行评估。在基线和第90天进行荧光素血管造影。主要结局指标是早期糖尿病性视网膜病变研究Snellen等效视力的改善以及临床检查中囊肿的消退。
在任何一次随访中，两组在任何一项结局指标上均未发现统计学上的显著差异。对慢性CME患者的亚组分析也显示两组之间无显著差异。
我们发现，对于急性或慢性CME，接受酮咯酸治疗的患者与接受酮咯酸加泼尼松龙治疗的患者在结局上没有统计学上的显著差异。局部类固醇疗法对慢性CME的价值仍未得到证实。
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