The South Asian cataract management study: complications, vision outcomes, and corneal endothelial cell loss in a randomized multicenter clinical trial comparing intracapsular cataract extraction with and without anterior chamber intraocular lens imp


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OBJECTIVE: To determine clinical outcomes of primary intracapsular cataract surgery with and without implantation of anterior chamber lenses. DESIGN: A multicenter randomized clinical trial. PARTICIPANTS: One thousand two hundred twenty-nine male and female patients 40-75 years of age with senile cataract. METHODS: Study patients were recruited from screening eye camps and outpatient clinics. Randomization to the two treatment groups was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuity, intraocular pressures, and corneal endothelial cell data were recorded before surgery and at 6 weeks, 12 months, and 24 months after surgery. Monitoring of the study was secured by a standardized image documentation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was performed with the Cell Soft software (Topcon Corporation, Japan). MAIN OUTCOME MEASURES: Visual acuity and central corneal endothelial cell loss. RESULTS: The patients were randomized to intraocular lens (IOL; n = 616) and no IOL (n = 613) implantation. Surgical complications were reported in 177 (14.4%) patients (IOL = 14.8%; no IOL = 14.0%). The most frequent complication observed was vitreous loss which occurred in 10.3% of eyes (IOL = 11.2%; no IOL = 9.5%). At the final examination (2 years after surgery), 88% of the operated eyes had a best corrected vision of 6/18 or better (IOL = 88.8%; no IOL = 86.6%). Analysis of corneal endothelial cell data showed a small but significantly greater cell loss 6 weeks after surgery in eyes with IOL compared with those without IOL, but no overall difference was found between the treatment groups in the long term follow-up. CONCLUSIONS: The findings indicate that there is a rationale for the use of anterior chamber intraocular lenses in primary intracapsular cataract surgery.
机译:目的:确定原发性囊内白内障手术在植入和不植入前房型晶状体的临床结果。设计:一项多中心随机临床试验。参与者:129名40-75岁的老年白内障男性和女性患者。方法:从筛查营地和门诊诊所招募研究患者。在筛选了预定的纳入和排除标准后,对两个治疗组进行了随机分组。在手术前以及手术后6周,12个月和24个月时记录人口统计学,视敏度,眼内压和角膜内皮细胞数据。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,确保了对研究的监控。用Cell Soft软件(日本Topcon公司)进行角膜内皮细胞图像的分析。主要观察指标:视力和角膜中央内皮细胞丢失。结果:患者被随机分为人工晶状体植入(IOL; n = 616),无人工晶体植入(n = 613)。据报告有177例(14.4%)患者发生手术并发症(IOL = 14.8%;无IOL = 14.0%)。观察到的最常见的并发症是发生在10.3%的眼睛中的玻璃体丧失(IOL = 11.2%;无IOL = 9.5%)。在最终检查(手术后2年)中,有88%的手术眼的最佳矫正视力为6/18或更好(IOL = 88.8%;无IOL = 86.6%)。角膜内皮细胞数据的分析显示,与没有IOL的眼相比,有IOL的眼术后6周的细胞损失较小,但明显更大,但是在长期随访中,各治疗组之间没有发现总体差异。结论:这些发现表明在原发性囊内白内障手术中使用前房人工晶状体是有理由的。



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