Clinical evaluation of a bacterially derived sodium hyaluronate 2.3% ophthalmic viscosurgical device

Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery

“…1,9,18,31 There was a mild IOP increase in early postoperative visits, as it has been described by other authors and in accordance with the known transient adverse event of hypertension after the use of any OVD. 26,32 There was only one case in which the IOP raised up to 18 mmHg on day 1, and it is worth mentioning that all patients presented a normal IOP by the last visit and that there were no statistically significant differences between groups at any of the visits. This IOP increment is consistent with the reported results shown to be transient and mild in this type of procedure, having no clinical impact on patients' final results and long-term ocular integrity.…”

“…Other previous studies have described similar results for these variables, presenting a significant yet mild incidence of flare and cellularity during the early postoperative period with a complete resolution by the 1-month evaluation. 32 Furthermore, the clinical performance of both HEC and PRO-149 was evaluated with a survey based in the general performance key aspects during a cataract surgery, as other authors have done previously. 21 The acceptance rate for the OVDs was evaluated and 97.2% for each group were rated as "good to very good".…”

“…However, previously published studies have reported a very similar percentage of ECC loss at both, the 30-day and 90-day time frames. 31,32 Another limitation was the fact that in the preclinical in vivo study the evaluation of OVDs was not undertaken through a fully realistic surgical technique which would have included the use of a phacoemulsification ultrasound hand piece as well as the implantation of an intraocular lens. Nevertheless, similar studies have been reported in which only AHE experiment was performed, whereas our study included both AHE and ACW models.…”

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

“…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 surgical procedure and addresses the trend of moving from animal-to bacterially derived sodium hyaluronate for use in OVDs.…”

“…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].…”