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两种市售眼科粘弹剂（OVDs）性能的临床比较：细菌衍生的Healon PRO OVD和动物衍生的Healon OVD。

Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD.

作者信息

Daas Loay, Larrosa Jose Manuel, Gavin Alicia, Isanta Carlos, Langenbucher Achim, Jackson Beth E, Tsai Linda, Janakiraman Priya, Guerrero Rafael, Seitz Berthold

机构信息

Department of Ophthalmology, Saarland University Medical Center UKS, Homburg, Saar, Germany.

Hospital Provincial de Nuestra Señora de Garcia, Zaragoza, Spain.

出版信息

J Ophthalmol. 2020 Nov 18;2020:8874850. doi: 10.1155/2020/8874850. eCollection 2020.

DOI:10.1155/2020/8874850
PMID:33859833
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8028729/
Abstract

This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a "spike" and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.

摘要

本临床研究比较了两种市售眼科粘弹剂（OVDs）在白内障摘除和晶状体植入正常使用条件下的临床性能：细菌衍生的Healon PRO OVD（试验组）和动物衍生的Healon OVD（对照组）。这项前瞻性、多中心、随机、平行、参与者/评估者双盲的上市后调查纳入了139名受试者（170只眼），其中116名（143只眼）接受了治疗（73只眼为试验组；70只眼为对照组）。根据标准程序，试验组和对照组的OVDs至少用于在白内障摘除术前充盈前房和保护内皮细胞。外科医生完成了术后OVD临床性能问卷，并在手术前和术后第1天使用Goldmann压平眼压计测量眼压。任何眼压测量值达到或高于30 mmHg被视为“眼压峰值”，并记录为特定研究的严重不良事件。结果发现，细菌衍生的Healon PRO OVD在统计学上不劣于动物衍生的Healon OVD对照组的整体临床性能；因此，原假设得到满足。在与眼压变化或安全性相关的任何其他终点方面，OVD组之间没有统计学上的显著差异，从而满足了其他假设。Healon PRO OVD在外科医生对注射 ease、透明度/可见度和人工晶状体植入 ease的评分方面显示出统计学上的显著改善。在严重和/或与器械相关的不良事件以及医学和晶状体检查结果方面，OVD组之间的安全性也相似。本临床研究结果支持细菌衍生的、目前市售的Healon PRO OVD的安全性和有效性，并表明两种OVDs的眼内手术性能相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/205dcc279270/joph2020-8874850.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/7fe10875df8b/joph2020-8874850.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/967f9b6990b6/joph2020-8874850.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/d301a88f3e34/joph2020-8874850.003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/e9f7d2dd3d3e/joph2020-8874850.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/bfc053250890/joph2020-8874850.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/5c2c2ecee4fd/joph2020-8874850.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/c3c84d188d8b/joph2020-8874850.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/205dcc279270/joph2020-8874850.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/7fe10875df8b/joph2020-8874850.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/967f9b6990b6/joph2020-8874850.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/d301a88f3e34/joph2020-8874850.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/d2a682911dcb/joph2020-8874850.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/e9f7d2dd3d3e/joph2020-8874850.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/bfc053250890/joph2020-8874850.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/5c2c2ecee4fd/joph2020-8874850.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/c3c84d188d8b/joph2020-8874850.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7281/8028729/205dcc279270/joph2020-8874850.009.jpg

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