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.
Highlights
Viscoelastics are indicated for use as a surgical aid in anterior segment procedures, including cataract surgery with or without an intraocular lens (IOL), secondary IOL implantation, corneal transplant surgery, and glaucoma filtration surgery [1,2,3,4]
Due to concerns of crossover contamination, animal-derived products have been losing favor in many parts of the world. e ophthalmic ophthalmic viscoelastic devices (OVDs) under investigation (Healon PRO OVD) is a bacterially derived sodium hyaluronate version, formulated to have similar physical properties as the animal-derived version (Healon OVD). is clinical study compared the clinical performance of the two OVDs under normal use conditions during the cataract surgical procedure
Viscoelastics are indicated for use as a surgical aid in anterior segment procedures [1,2,3, 4] and have an important protective role in minimising corneal trauma [5,6,7,8,9,10,11]. is clinical study compared the clinical performance of the two OVDs under normal use conditions during the cataract
Summary
Viscoelastics are indicated for use as a surgical aid in anterior segment procedures, including cataract surgery with or without an intraocular lens (IOL), secondary IOL implantation, corneal transplant surgery, and glaucoma filtration surgery [1,2,3,4]. Some established benefits of using viscoelastic materials in cataract surgery are endothelial cell protection and maintenance of the intraocular space [1]. Journal of Ophthalmology affects both surgical tissue manipulation [12,13,14] and postoperative IOP [15,16,17,18,19,20,21]. Traditional viscoelastics, such as the Healon ophthalmic viscoelastic device (OVD), are developed from sodium hyaluronate derived from rooster combs. Due to concerns of crossover contamination, animal-derived products have been losing favor in many parts of the world. e ophthalmic OVD under investigation (Healon PRO OVD) is a bacterially derived sodium hyaluronate version, formulated to have similar physical properties as the animal-derived version (Healon OVD). is clinical study compared the clinical performance of the two OVDs under normal use conditions during the cataract surgical procedure
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