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高度近视眼中用于人工晶状体屈光度计算的囊袋张力环植入术:一项随机临床试验的二次分析

Capsular Tension Ring Implantation for Intraocular Lens Power Calculation in Highly Myopic Eyes: Secondary Analysis of a Randomized Clinical Trial.

作者信息

Lin Haowen, Zhang Jiaqing, Jin Aixia, Zhang Yifan, Zhang Yu, Jin Ling, Xu Yifan, Xie Xiaohang, Qiu Xiaozhang, Dai Boyufei, Tan Xuhua, Luo Lixia, Liu Yizhi

机构信息

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Vision Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.

Shenzhen Eye Institute, Shenzhen Eye Hospital, Jinan University, Shenzhen, China.

出版信息

JAMA Ophthalmol. 2025 May 1;143(5):373-381. doi: 10.1001/jamaophthalmol.2025.0110.

Abstract

IMPORTANCE

Capsular tension ring (CTR) implantation has been shown to reduce intraocular lens (IOL) decentration and tilt in high myopia. However, the effect of CTR implantation in highly myopic eyes on IOL power calculation remains unclear, particularly in new-generation formulas.

OBJECTIVE

To evaluate the influence of CTR implantation on IOL power calculation in highly myopic eyes.

DESIGN, SETTING, AND PARTICIPANTS: This is a prespecified secondary analysis of outcomes of a randomized clinical trial conducted between November 2021 and September 2023 at the Zhongshan Ophthalmic Center in Guangzhou, China. Cataract patients with an axial length (AL) of 26 mm or longer were enrolled and stratified into 3 strata based on AL (stratum 1: AL 26-<28 mm; stratum 2: AL 28-<30 mm; stratum 3: AL ≥30 mm).

INTERVENTIONS

Participants were stratified based on AL and randomized to the CTR group (a C-loop IOL combined with a CTR) or the control group (only a C-loop IOL) within each stratum.

MAIN OUTCOMES AND MEASURES

Predictive outcomes of 6 new-generation formulas and 4 traditional formulas were evaluated. The arithmetic and absolute prediction error (PE) and the percentages of eyes within ±0.25 diopter (D), ±0.50 D, ±0.75 D, and ±1.00 D of PE were analyzed.

RESULTS

A total of 186 eyes of 186 participants were randomized into the CTR group (93 eyes [50%]) or control group (93 eyes [50%]). Excluding a withdrawal case and 24 eyes with best-corrected visual acuity less than 20/40, 80 eyes in the CTR group (86.0%) and 81 eyes in the control group (87.1%) were analyzed. Of 161 participants analyzed, overall mean (SD) participant age was 56.7 (10.5) years, and 100 participants (62.1%) were female. No differences were observed in arithmetic PE between the CTR and control groups in any strata. The CTR group showed smaller absolute PE in all new-generation formulas and higher percentage of PE within ±0.50 D in the Emmetropia Verifying Optical 2.0, Hoffer QST, LISA, and Pearl-DGS formulas only for eyes with an AL of 30 mm or longer compared with the control group. In traditional formulas, no differences were observed between the 2 groups in any strata.

CONCLUSIONS AND RELEVANCE

In this secondary analysis, CTR implantation in highly myopic eyes did not affect the target refraction and can improve the prediction accuracy of new-generation IOL calculation formulas in eyes with AL of 30 mm or longer. These findings support use of CTR implantation in eyes with an AL of 30 mm or longer.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05161520.

摘要

重要性

有研究表明,植入囊袋张力环(CTR)可减少高度近视患者人工晶状体(IOL)的偏心和倾斜。然而,CTR植入对高度近视眼IOL屈光度计算的影响仍不明确,尤其是在新一代公式中。

目的

评估CTR植入对高度近视眼IOL屈光度计算的影响。

设计、地点和参与者:这是一项对2021年11月至2023年9月在中国广州中山眼科中心进行的随机临床试验结果的预先指定的二次分析。纳入眼轴长度(AL)为26mm或更长的白内障患者,并根据AL分为3个层(第1层:AL 26 - <28mm;第2层:AL 28 - <30mm;第3层:AL≥30mm)。

干预措施

参与者根据AL分层,并在各层内随机分为CTR组(C袢IOL联合CTR)或对照组(仅C袢IOL)。

主要结局和测量指标

评估6种新一代公式和4种传统公式的预测结果。分析算术和绝对预测误差(PE)以及PE在±0.25屈光度(D)、±0.50D、±0.75D和±1.00D范围内的眼的百分比。

结果

186名参与者的186只眼被随机分为CTR组(93只眼[50%])或对照组(93只眼[50%])。排除1例退出病例和24只最佳矫正视力低于20/40的眼后,对CTR组的80只眼(86.0%)和对照组的81只眼(87.1%)进行了分析。在161名接受分析的参与者中,参与者的总体平均(标准差)年龄为56.7(10.5)岁,100名参与者(62.1%)为女性。在任何层中,CTR组和对照组之间的算术PE均未观察到差异。与对照组相比,仅对于AL为30mm或更长的眼,CTR组在所有新一代公式中显示出较小的绝对PE,并且在正视验证光学2.0、霍夫QST、LISA和Pearl - DGS公式中,PE在±0.50D范围内的眼的百分比更高。在传统公式中,两组在任何层中均未观察到差异。

结论和相关性

在这项二次分析中,高度近视眼植入CTR不影响目标屈光,并可提高AL为30mm或更长的眼中新一代IOL计算公式的预测准确性。这些发现支持在AL为30mm或更长的眼中使用CTR植入。

试验注册

ClinicalTrials.gov标识符:NCT05161520。

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