南亚白内障治疗研究：一项随机多中心临床试验中的并发症、视力结果及角膜内皮细胞丢失情况，该试验比较了有和无前房型人工晶状体植入的囊内白内障摘除术。

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 implantation.

作者信息

Snellingen T, Shrestha J K, Huq F, Husain R, Koirala S, Rao G N, Pokhrel R P, Kolstad A, Upadhyay M P, Apple D J, Arnesen E, Cheng H, Olsen E G, Vogel M

机构信息

Department of Ophthalmology, Institute of Clinical Medicine, University of Tromsø, Norway.

出版信息

Ophthalmology. 2000 Feb;107(2):231-40. doi: 10.1016/s0161-6420(99)00008-1.

DOI:10.1016/s0161-6420(99)00008-1

PMID:10690817

Abstract

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.

摘要

目的

确定一期囊内白内障手术植入与未植入前房人工晶状体的临床效果。

设计

一项多中心随机临床试验。

参与者

1229例年龄在40至75岁之间的老年性白内障男女患者。

方法

研究患者从筛查眼科营地和门诊诊所招募。在根据预定的纳入和排除标准进行筛查后，将患者随机分为两个治疗组。在手术前以及手术后6周、12个月和24个月记录人口统计学、视力、眼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图像记录程序来确保研究的监测。使用Cell Soft软件（日本拓普康公司）对角膜内皮细胞图像进行分析。

主要观察指标

视力和中央角膜内皮细胞损失。

结果

患者被随机分为植入人工晶状体（IOL；n = 616）和未植入人工晶状体（n = 613）两组。共177例（14.4%）患者报告了手术并发症（植入IOL组 = 14.8%；未植入IOL组 = 14.0%）。观察到的最常见并发症是玻璃体脱出，发生率为10.3%（植入IOL组 = 11.2%；未植入IOL组 = 9.5%）。在最终检查（手术后2年）时，88%的手术眼最佳矫正视力达到6/18或更好（植入IOL组 = 88.8%；未植入IOL组 = 86.6%）。角膜内皮细胞数据分析显示，与未植入IOL的眼睛相比，植入IOL的眼睛在手术后6周细胞损失虽小但明显更大，但在长期随访中治疗组之间未发现总体差异。