Br J Ophthalmol. 1995 Nov;79(11):1029-35. doi: 10.1136/bjo.79.11.1029.
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.
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.
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.
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.
对一项多中心随机临床试验的首批662例囊内白内障摘除术（ICCE）患者进行研究，比较植入四点多曲（Cilco Kelman Choyce改良型）前房型人工晶状体（AC IOL）与未植入人工晶状体两组的手术并发症发生率、短期临床结局及角膜内皮细胞损失情况。研究在术后6周进行。
根据预定的纳入和排除标准进行筛选后进行随机分组。术前及术后6周记录人口统计学资料、视力、眼压及角膜内皮细胞数据。记录手术过程、并发症及术后不良反应的详细情况。使用IMAGEnet数字成像系统，通过标准化图像记录程序对所有患者进行研究监测。使用CELL SOFT软件分析程序对角膜内皮细胞图像进行分析。
343例患者被随机分配至植入人工晶状体组，319例被分配至未植入人工晶状体组。12例（3.5%）人工晶状体植入手术因并发症而中止。103例（15.6%）手术报告有并发症（植入人工晶状体组为16.9%，未植入人工晶状体组为14.1%，p = 0.37）。观察到最常见的并发症是玻璃体脱出，其次是单纯囊膜破裂、意外的囊外白内障摘除术及虹膜根部断离。术后6周，研究总体人群的平均角膜内皮细胞损失为17.2%（标准差13.1%）（植入人工晶状体组为18.5%，未植入人工晶状体组为16.1%，p = 0.05）。随访至术后6周，植入人工晶状体组的术后并发症发生率显著更高（植入人工晶状体组为6.9%，未植入人工晶状体组为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%的患者最佳矫正视力达到6/18或更好。研究组之间的视力结局无显著差异。
在本研究中心进行的原发性ICCE手术中，与未植入人工晶状体的ICCE相比，植入多曲AC人工晶状体并未增加手术并发症风险或短期威胁视力的不良临床结局风险。研究组之间术后6周角膜内皮细胞损失的比较显示无临床显著差异。两组之间平均细胞损失的差异具有统计学意义。
