Zhu Zehui, Chang Pingjun, Huang Feng, Shen Songqing, Zhao Xiaomeng, Ji Xinpei, Zhao Yun E
Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.
National Clinical Research Center for Ocular Diseases, Wenzhou, Zhejiang, China.
Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24.
To compare surgical outcomes of 2.2 mm clear corneal incision (CCI) between a three-dimensional (3D) visualization system and traditional binocular microscope (BM) for phacoemulsification and intraocular lens implantation surgery.
In this randomized controlled clinical study, 60 eyes with age-related cataracts were divided into two groups receiving cataract surgery using either a 3D vision system (n = 30 eyes) (3D group) or a binocular microscope (n = 30 eyes) (BM group). We recorded and statistically analyzed surgical parameters and pre- and postoperative ocular parameters. Primary outcomes included the change in endothelial cell density (ECD) and CCI architecture, and secondary outcomes comprised other ocular parameters and surgical parameters. All procedures complied with the tenets of the Declaration of Helsinki.
Of the 60 eyes randomly assigned between January 5, 2021, and May 9, 2021, 55 (26 eyes in the 3D group and 29 eyes in the BM group) were analyzed. The ECD loss rate was 8.1% in the 3D group and 12.3% in the BM group, but the difference was not statistically significant. Local detachment of Descemet's membrane was seen in 50% (13 eyes, 3D group) and 51.6% (15 eyes, BM group), wound gaping at the endothelial side in 15.4% (four eyes, 3D group) and 10.3% (four eyes, BM group), gaping at the epithelial side in 11.5% (three eyes, 3D group) and 6.9% (two eyes, BM group), and misalignment of the incision in 3.4% (one eye, BM group) 1 day after surgery. These abnormalities improved with time. There was no difference between the 3D group and BM group in terms of other ocular parameters or surgical parameters before and after surgery.
Using the 3D surgical system for phacoemulsification and IOL implantation surgery seems to result in similar ECD and CCI conditions as using a conventional binocular microscope.
The protocol was registered on ClinicalTrials.gov (NCT04839250).
比较三维（3D）可视化系统与传统双目显微镜（BM）在白内障超声乳化吸除联合人工晶状体植入手术中采用2.2毫米透明角膜切口（CCI）的手术效果。
在这项随机对照临床研究中，60例年龄相关性白内障患者被分为两组，分别使用3D视觉系统（n = 30眼）（3D组）或双目显微镜（n = 30眼）（BM组）进行白内障手术。我们记录并统计分析了手术参数以及术前和术后的眼部参数。主要结局包括内皮细胞密度（ECD）的变化和CCI结构，次要结局包括其他眼部参数和手术参数。所有手术均遵循《赫尔辛基宣言》的原则。
在2021年1月5日至2021年5月9日随机分配的60眼中，分析了55眼（3D组26眼，BM组29眼）。3D组的ECD损失率为8.1%，BM组为12.3%，但差异无统计学意义。3D组50%（13眼）和BM组51.6%（15眼）出现后弹力层局部脱离，3D组15.4%（4眼）和BM组10.3%（4眼）在内皮侧出现切口裂开，3D组11.5%（3眼）和BM组6.9%（2眼）在上皮侧出现切口裂开，术后1天BM组3.4%（1眼）出现切口错位。这些异常情况随时间改善。3D组和BM组在手术前后的其他眼部参数或手术参数方面无差异。
在白内障超声乳化吸除联合人工晶状体植入手术中使用3D手术系统似乎与使用传统双目显微镜导致的ECD和CCI情况相似。
该方案已在ClinicalTrials.gov（NCT04839250）上注册。
