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首页> 美国卫生研究院文献>The British Journal of Ophthalmology >The South Asian Cataract Management Study. I. The first 662 cataract surgeries: a preliminary report.
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The South Asian Cataract Management Study. I. The first 662 cataract surgeries: a preliminary report.

机译：南亚白内障管理研究。一首批662例白内障手术：初步报告。

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AIMS--The first 662 cases of a multicentre randomised clinical trial of intracapsular cataract extraction (ICCE) with and without implantation of a four point multiflex (Cilco Kelman Choyce Modification) anterior chamber intraocular lens (AC IOL) were studied after 6 weeks to compare frequency of surgical complications, short term clinical outcomes, and corneal endothelial cell loss between groups. METHODS--Randomisation was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuities, intraocular pressures, and corneal endothelium cell data were recorded preoperatively and at 6 weeks. Details of surgical procedure, complications, and postoperative adverse reactions were recorded. Monitoring of the study was secured by a standardised image documentation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was done using the CELL SOFT software analysis program. RESULTS--343 patients were randomised to IOL and 319 to no IOL. Twelve IOL implantations (3.5%) were aborted because of complications. A complication was reported in 103 (15.6%) of the surgical procedures (IOL = 16.9%, no IOL = 14.1%, p = 0.37). The most frequent complication observed was vitreous loss followed by plain capsular rupture, unplanned ECCE, and iris dialysis. Mean corneal endothelial cell loss 6 weeks after surgery was 17.2% (SD 13.1%) in the total study population (IOL = 18.5% no IOL = 16.1%, p = 0.05). The postoperative complications registered until 6 week follow up were significantly higher in the IOL group (IOL = 6.9%, no IOL = 2.6%, p = 0.02), mainly due to mild to moderate iritis needing prolonged use of steroids. Eighty nine per cent of the patients had a best corrected visual acuity of 6/18 or better. There was no significant difference in visual outcome between study groups. CONCLUSIONS--The implantation of a multiflex AC IOL in primary ICCE surgery in the centres of this study did not increase the risk of surgical complications or short term sight threatening adverse clinical outcomes compared with ICCE without lens. Comparisons of corneal endothelial cell loss after 6 weeks between study groups showed no clinically significant difference. The difference in mean cell loss between groups was statistically significant.
机译：目的-对前662例进行多中心随机临床试验的白内障囊内白内障摘除术（ICCE）植入和不植入四点multiflex（Cilco Kelman Choyce Modification）前房人工晶状体（AC IOL）进行比较，在6周后进行比较两组之间的手术并发症发生频率，短期临床结果和角膜内皮细胞损失。方法-在筛选预定的纳入和排除标准后进行随机化。术前和第6周记录人口统计学，视敏度，眼压和角膜内皮细胞数据。记录手术过程，并发症和术后不良反应的详细信息。通过使用IMAGEnet数字成像系统对所有患者进行标准化的图像记录程序来确保对研究的监控。使用CELL SOFT软件分析程序对角膜内皮细胞图像进行分析。结果-343例患者被随机分为IOL，319例无IOL。由于并发症，十二次人工晶体植入（3.5％）被中止。在103例（15.6％）外科手术中报道了并发症（IOL = 16.9％，无IOL = 14.1％，p = 0.37）。观察到的最常见的并发症是玻璃体损失，随后是单纯的囊膜破裂，计划外的ECCE和虹膜透析。在整个研究人群中，术后6周的平均角膜内皮细胞损失率为17.2％（标准差13.1％）（IOL = 18.5％，无IOL = 16.1％，p = 0.05）。 IOL组直至6周随访的术后并发症的发生率明显更高（IOL = 6.9％，无IOL = 2.6％，p = 0.02），主要是由于轻度至中度虹膜炎需要长期使用类固醇。 89％的患者的最佳矫正视力为6/18或更高。研究组之间的视觉结果无显着差异。结论-与没有晶状体的ICCE相比，在本研究中心的原发ICCE手术中植入multiflex AC IOL不会增加手术并发症或短期视力威胁不良临床结果的风险。研究组之间6周后角膜内皮细胞损失的比较显示无临床显着差异。两组之间平均细胞丢失的差异具有统计学意义。

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