Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD
المؤلفون المشاركون
Daas, Loay
Larrosa, Jose Manuel
Gavin, Alicia
Isanta, Carlos
Langenbucher, Achim
Jackson, Beth E.
Tsai, Linda
Janakiraman, Priya
Guerrero, Rafael
Seitz, Berthold
المصدر
العدد
المجلد 2020، العدد 2020 (31 ديسمبر/كانون الأول 2020)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2020-11-18
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص EN
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.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Daas, Loay& Larrosa, Jose Manuel& Tsai, Linda& Janakiraman, Priya& Guerrero, Rafael& Seitz, Berthold…[et al.]. 2020. Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD. Journal of Ophthalmology،Vol. 2020, no. 2020, pp.1-8.
https://search.emarefa.net/detail/BIM-1189827
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Tsai, Linda…[et al.]. Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD. Journal of Ophthalmology No. 2020 (2020), pp.1-8.
https://search.emarefa.net/detail/BIM-1189827
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Daas, Loay& Larrosa, Jose Manuel& Tsai, Linda& Janakiraman, Priya& Guerrero, Rafael& Seitz, Berthold…[et al.]. Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD. Journal of Ophthalmology. 2020. Vol. 2020, no. 2020, pp.1-8.
https://search.emarefa.net/detail/BIM-1189827
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1189827
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر