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OZil 超声乳化手柄在脱位晶状体碎片手术中的疗效和安全性:一项随机对照试验。

Efficacy and safety of the OZil phacoemulsification handpiece in dropped lens fragment surgery: a randomized controlled trial.

机构信息

Department of Ophthalmology, Command Hospital (Eastern Command), Kolkata, India.

Department of Anaesthesia, Command Hospital (Eastern Command), Kolkata, India.

出版信息

Rom J Ophthalmol. 2024 Jul-Sep;68(3):287-293. doi: 10.22336/rjo.2024.52.

DOI:10.22336/rjo.2024.52
PMID:39464758
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11503222/
Abstract

OBJECTIVE

Phacoemulsification is the predominant method for cataract surgery, but complications like lens nuclei dislodgment into the vitreous cavity pose significant risks, including inflammation, glaucoma, retinal tears, and vision loss. Traditional management involves pars plana vitrectomy with phacofragmentation, which can increase the risk of retinal damage due to repulsive forces. This study tests whether the OZil phacoemulsification handpiece, employing torsional movement, offers a safer alternative by minimizing repulsive forces and reducing surgical duration compared to the traditional phacofragmatome.

METHODS

This prospective study, conducted in a tertiary care hospital in eastern India from January to June 2023, enrolled 40 patients with nucleus dislocation during cataract surgery. Patients were randomized into Group 1 (traditional phacofragmatome) and Group 2 (OZil handpiece). Primary objectives included comparing the duration of surgery and intraoperative complications. Secondary objectives assessed postoperative best-corrected visual acuity (BCVA), surgical site safety, and cystoid macular edema (CME) incidence.

RESULTS

Group 2 demonstrated significantly shorter surgical durations (110±2.54 seconds) compared to Group 1 (152±2.23 seconds, p < 0.001). The frequency of nucleus falls was considerably lower in Group 2 (p < 0.001). Postoperative BCVA and CME incidence showed no significant differences between groups. Multiple regression analysis confirmed the OZil handpiece significantly reduced surgical duration (β = -0.40, p < 0.001) without compromising safety.

DISCUSSION

The OZil handpiece's rotational cutting mechanism offers a significant advantage in reducing surgical time while improving the followability of lens fragments, as compared to the traditional phacofragmatome. It addresses one of the key limitations of phacofragmentation by minimizing fragment displacement, where repulsive forces can complicate the procedure. Although both techniques showed similar safety profiles, the OZil handpiece's operational efficiency makes it a promising alternative for managing posteriorly displaced lens fragments in complex cases.

CONCLUSIONS

The OZil phacoemulsification handpiece significantly enhances surgical efficiency and safety in nucleus drop surgeries. Its integration into existing phacofragmatome systems can lead to major advancement in the ophthalmic surgical armamentarium, ensuring improved patient care.

摘要

目的

超声乳化术是白内障手术的主要方法,但晶状体核脱位进入玻璃体腔等并发症会带来严重风险,包括炎症、青光眼、视网膜裂孔和视力丧失。传统的治疗方法包括经睫状体平坦部玻璃体切除术联合超声粉碎术,但由于斥力的存在,可能会增加视网膜损伤的风险。本研究旨在测试采用扭转运动的 OZil 超声乳化手柄是否通过最小化斥力并缩短手术时间,相对于传统的超声粉碎刀而言,是一种更安全的替代方法。

方法

本前瞻性研究于 2023 年 1 月至 6 月在印度东部的一家三级护理医院进行,共纳入 40 例白内障手术中晶状体核脱位的患者。患者随机分为 1 组(传统超声粉碎刀)和 2 组(OZil 手柄)。主要研究目标包括比较手术时间和术中并发症。次要研究目标评估术后最佳矫正视力(BCVA)、手术部位安全性和囊样黄斑水肿(CME)的发生率。

结果

2 组的手术时间明显缩短(110±2.54 秒比 152±2.23 秒,p<0.001)。2 组的晶状体核脱落频率明显降低(p<0.001)。两组术后 BCVA 和 CME 发生率无显著差异。多元回归分析证实,OZil 手柄显著缩短了手术时间(β=-0.40,p<0.001),同时不影响安全性。

讨论

与传统的超声粉碎刀相比,OZil 手柄的旋转切割机制具有显著优势,可减少手术时间,同时改善晶状体碎片的跟随性。它通过最小化碎片移位来解决超声粉碎术的一个关键局限性,在该过程中,斥力会使手术复杂化。虽然两种技术的安全性相似,但 OZil 手柄的操作效率使其成为处理复杂病例中后脱位晶状体碎片的一种有前途的替代方法。

结论

OZil 超声乳化手柄显著提高了晶状体核脱位手术的手术效率和安全性。将其集成到现有的超声粉碎刀系统中,可以使眼科手术设备得到重大改进,从而改善患者的治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5bd5/11503222/6d5fc13a9e13/RomJOphthalmol-68-287-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5bd5/11503222/42b1aed00b8a/RomJOphthalmol-68-287-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5bd5/11503222/6d5fc13a9e13/RomJOphthalmol-68-287-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5bd5/11503222/42b1aed00b8a/RomJOphthalmol-68-287-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5bd5/11503222/6d5fc13a9e13/RomJOphthalmol-68-287-g002.jpg

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本文引用的文献

1
Intravitreal Phacoemulsification Using Torsional Handpiece for Retained Lens Fragments.使用扭转式手柄进行玻璃体腔内超声乳化术治疗残留晶状体碎片
J Ophthalmic Vis Res. 2016 Jul-Sep;11(3):268-70. doi: 10.4103/2008-322X.188406.
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Management of the dropped nuclear fragments.掉落核碎片的处理
Br J Ophthalmol. 2013 Jan;97(1):2-4. doi: 10.1136/bjophthalmol-2012-301799. Epub 2012 Aug 31.
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Removal of posterior segment retained lens material using the OZil phacoemulsification handpiece versus Fragmatome during pars plana vitrectomy.
在经睫状体平坦部玻璃体切除术中,使用 OZil 超声乳化手柄与 Fragmatome 去除后段残留晶状体物质。
Retina. 2012 Nov-Dec;32(10):2119-26. doi: 10.1097/IAE.0b013e31825a89c3.
4
Pars plana torsional phacoemulsification for removal of retained lens material during pars plana vitrectomy.经睫状体平坦部扭转超声乳化术用于在经睫状体平坦部玻璃体切除术中清除残留晶状体物质。
Retina. 2011 Apr;31(4):804-5. doi: 10.1097/IAE.0b013e31820c8402.
5
25-Gauge pars plana vitrectomy for retained lens fragments.25G 经平坦部玻璃体切除术治疗残留晶状体碎片。
Retina. 2010 Jun;30(6):843-9. doi: 10.1097/IAE.0b013e3181cd47d5.
6
Comparison of conventional and torsional mode (OZil) phacoemulsification: randomized prospective clinical study.传统超声乳化与扭转模式(Ozil)超声乳化的比较:随机前瞻性临床研究。
Eur J Ophthalmol. 2009 Nov-Dec;19(6):984-9. doi: 10.1177/112067210901900614.
7
Intravitreal phacoemulsification with pars plana vitrectomy for management of posteriorly dislocated nucleus or lens fragments.经平坦部玻璃体切割术联合玻璃体腔内超声乳化术治疗后脱位的晶状体核或晶状体碎片。
Eur J Ophthalmol. 2010 Jan-Feb;20(1):115-9. doi: 10.1177/112067211002000115.
8
Managing retained lens fragments: raising the bar.处理残留晶状体碎片:提高标准。
Am J Ophthalmol. 2009 Apr;147(4):569-70. doi: 10.1016/j.ajo.2008.12.030.
9
Clinical predictors and outcomes of pars plana vitrectomy for retained lens material after cataract extraction.白内障摘除术后残留晶状体物质行玻璃体切割术的临床预测因素及预后
Am J Ophthalmol. 2009 Apr;147(4):587-594.e1. doi: 10.1016/j.ajo.2008.10.026. Epub 2009 Feb 4.
10
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