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晚期囊袋内人工晶状体脱位矫正手术后角膜内皮细胞的纵向损失:一项随机临床试验。

Longitudinal corneal endothelial cell loss after corrective surgery for late in-the-bag IOL dislocation: a randomized clinical trial.

作者信息

Dalby Marius, Kristianslund Olav, Østern Atle Einar, Falk Ragnhild Sørum, Drolsum Liv

机构信息

From the Department of Ophthalmology (Dalby, Kristianslund, Østern, Drolsum), Oslo Centre for Biostatistics and Epidemiology (Falk), Oslo University Hospital, Institute of Clinical Medicine, University of Oslo (Dalby, Drolsum), Oslo, Norway.

出版信息

J Cataract Refract Surg. 2020 Jul;46(7):1030-1036. doi: 10.1097/j.jcrs.0000000000000213.

Abstract

PURPOSE

To compare safety regarding longitudinal corneal endothelial cell loss (ECL) after IOL exchange vs IOL repositioning for late in-the-bag IOL dislocation.

SETTING

Oslo University Hospital, Norway.

DESIGN

Prospective, parallel group, randomized clinical trial.

METHODS

During a 3-year period, 104 patients were randomly assigned to groups receiving either IOL exchange with retropupillary fixation of an iris-claw IOL (n = 50) or IOL repositioning by scleral suturing (n = 54). All operations were performed by 1 surgeon with an anterior approach. Endothelial cell density (ECD) and central corneal thickness were measured preoperatively and at 6 months, 1 year, and 2 years postoperatively. A linear mixed model was applied for the longitudinal analysis, where patients with at least 1 ECD measurement were included (n = 44 exchange; n = 50 repositioning). The main outcome measure was 2-year longitudinal ECL in IOL exchange compared with IOL repositioning.

RESULTS

The longitudinal ECL was similar between the IOL exchange (n = 44) and IOL repositioning (n = 50) groups during the 2 years of follow-up (17.5% vs 15.3%, P = .15). A subgroup analysis found no reason to advise against either method for patients with low preoperative ECD (<1500 cells/mm). The mean central corneal thickness was similar between the 2 groups and remained stable over 2 years of follow-up.

CONCLUSIONS

This randomized clinical trial of late in-the-bag IOL dislocation surgery found that exchanging the IOL was as safe as repositioning in terms of 2-year longitudinal ECL.

摘要

目的

比较在晶状体后房型人工晶状体(IOL)脱位晚期行IOL置换与IOL重新定位后纵向角膜内皮细胞丢失(ECL)的安全性。

设置

挪威奥斯陆大学医院。

设计

前瞻性、平行组、随机临床试验。

方法

在3年期间,104例患者被随机分配至接受经瞳孔后固定虹膜夹型IOL的IOL置换组(n = 50)或巩膜缝线固定IOL重新定位组(n = 54)。所有手术均由1名外科医生采用前路入路进行。术前以及术后6个月、1年和2年测量内皮细胞密度(ECD)和中央角膜厚度。应用线性混合模型进行纵向分析,纳入至少有1次ECD测量值的患者(n = 44例置换;n = 50例重新定位)。主要结局指标是IOL置换与IOL重新定位相比2年的纵向ECL。

结果

在2年随访期间,IOL置换组(n = 44)和IOL重新定位组(n = 50)的纵向ECL相似(17.5%对15.3%,P = 0.15)。亚组分析发现,对于术前ECD低(<1500个细胞/mm²)的患者,没有理由不推荐这两种方法中的任何一种。两组的平均中央角膜厚度相似,并且在2年随访期间保持稳定。

结论

这项关于晶状体后房型IOL脱位晚期手术的随机临床试验发现,就2年纵向ECL而言,IOL置换与重新定位一样安全。

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