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新型非空化手持晶状体切除术系统在 665 例连续白内障手术中的首次人体临床性能。

First in-human clinical performance of a new non-cavitating handheld lensectomy system in 665 consecutive cataract surgeries.

机构信息

From the Ophthalmology, New York Eye and Ear Infirmary of Mount Sinai, New York, New York (Ianchulev, Kamthan, Li); Refractive Surgery, Virginia Eye Consultants, Norfolk, Virginia (Yeu); Wolfe Eye Clinic, Marshalltown, Iowa (Hu); The Eye Centers of Racine and Kenosha, Racine, Wisconsin (Singh); Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania (Pantanelli); The Cape Coral Eye Center, Cape Coral, Florida (Tyson).

出版信息

J Cataract Refract Surg. 2024 Jul 1;50(7):693-697. doi: 10.1097/j.jcrs.0000000000001446.

DOI:10.1097/j.jcrs.0000000000001446
PMID:38517982
Abstract

PURPOSE

To investigate the intraoperative performance and lens fragmentation efficacy of a non-cavitating handheld lensectomy system in mild, moderate, and severe cataract.

SETTING

Ambulatory surgical centers.

DESIGN

Retrospective consecutive case series.

METHODS

665 consecutive eyes underwent cataract surgery by 12 surgeons using a new handheld non-cavitating lensectomy system for nuclear fragmentations and extraction. Intraoperative measurements included surgical time, miLOOP pretreatment, and irrigation fluid use.

RESULTS

Of the 665 eyes, 38 (6%), 468 (70%), 126 (19%), and 33 (5%) were of grade 1, 2, 3, and 4 nuclear densities, respectively, as graded by the surgeon intraoperatively. Successful nuclear fragmentation, lens extraction, and cortical removal were achieved in all eyes. Total nucleus fragmentation and extraction times were 70.1 seconds, 100.3 seconds, 132.6 seconds, and 287.9 seconds for grades 1, 2, 3, and 4, respectively ( P < .001). In addition, irrigation and aspiration cortical removal times were 64.1 seconds, 51.1 seconds, 48.5 seconds, and 59.0 seconds, respectively ( P = .14). There was a low rate of capsular tear (3 cases in 665 surgeries, 0.45%) and no other emergent adverse events.

CONCLUSIONS

The miCOR handheld non-cavitating lensectomy system demonstrated nuclear fragmentation and extraction in the absence of intraocular cavitation across all grades of nuclear densities.

摘要

目的

研究一种非空化手持晶状体切除术系统在轻度、中度和重度白内障中的术中表现和晶状体碎裂效果。

设置

门诊手术中心。

设计

回顾性连续病例系列。

方法

12 名外科医生使用新型非空化手持晶状体切除术系统对 665 只连续眼进行白内障手术,用于核碎片和提取。术中测量包括手术时间、miLOOP 预处理和冲洗液使用。

结果

在 665 只眼中,38 只(6%)、468 只(70%)、126 只(19%)和 33 只(5%)分别为核密度 1、2、3 和 4 级,由外科医生术中分级。所有眼均成功进行核碎裂、晶状体提取和皮质去除。1 级、2 级、3 级和 4 级核的总核碎裂和提取时间分别为 70.1 秒、100.3 秒、132.6 秒和 287.9 秒(P<0.001)。此外,冲洗和抽吸皮质去除时间分别为 64.1 秒、51.1 秒、48.5 秒和 59.0 秒(P=0.14)。囊膜撕裂发生率低(665 例手术中有 3 例,0.45%),无其他紧急不良事件。

结论

miCOR 手持非空化晶状体切除术系统在所有核密度级均无眼内空化的情况下显示出核碎裂和提取效果。

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Micro-interventional pre-treatment for nucleus disassembly in the setting of non-cavitating sonic lensectomy: real-world evidence study in 512 cases.非空化超声晶状体切除术中用于核分解的微介入预处理:512例真实世界证据研究
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