Purpose

To compare the safety and effectiveness of bacterially derived and animal-derived sodium hyaluronate 2.3% ophthalmic viscosurgical devices (OVD) (Healon5 PRO and Healon5, respectively) in cataract surgery.

Setting

United States multicenter study.

Design

Prospective, randomized, masked, controlled study.

Methods

Adult patients having bilateral cataract extraction and posterior chamber intraocular lens implantation were randomly assigned to receive Healon5 PRO OVD in 1 eye (study group) and Healon5 OVD in the fellow eye (control group). The endothelial cell count (ECC) was measured preoperatively and 3 months postoperatively. Tonometry was performed preoperatively and at the 6-hour, 1-day, 1-week, 1-month, and 3-month timepoints. The cumulative rate of postoperative intraocular pressure (IOP) spikes (≥30 mm Hg) was calculated. Changes from baseline in IOP, edema, inflammation, serious adverse events, and visual acuity were also assessed.

Results

The study comprised 213 and 208 treated and paired-eye patients, respectively. At 3 months, there was no statistically significant difference in the mean percentage ECC change from baseline between study group and the control group (−5.55% versus −6.66%; mean difference 1.11% ± 11.89% [SD]; 95% confidence interval (CI), −0.52 to 2.74) or the cumulative IOP spike rate (8.2% versus 6.3%; mean percentage difference −1.9%; 95% CI, −5.46% to 1.61%). At 3 months, both OVD groups had significant reductions in IOP from baseline (−1.37 mm Hg and −1.32 mm Hg, respectively; both P < .0001). The distribution of edema, inflammation, serious adverse events, and visual acuity outcomes was also similar between the groups.

Conclusion

The 2 OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.

中文翻译：

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细菌来源的透明质酸钠2.3％眼科内窥镜手术设备的临床评估

目的

为了比较细菌性和动物性透明质酸钠2.3％眼科内窥镜手术设备（OVD）（分别为Healon5 PRO和Healon5）在白内障手术中的安全性和有效性。

设置

美国多中心研究。

设计

前瞻性，随机，隐蔽，对照研究。

方法

随机分配有双侧白内障摘除和后房人工晶状体植入的成年患者，每只眼睛接受Healon5 PRO OVD（研究组），另一只眼睛接受Healon5 OVD（对照组）。术前和术后3个月测量内皮细胞计数（ECC）。术前和在6小时，1天，1周，1个月和3个月的时间点进行眼压计。计算术后眼内压（IOP）峰值（≥30mm Hg）的累积率。还评估了眼压，水肿，炎症，严重不良事件和视敏度相对于基线的变化。

结果

该研究分别包括213名和208名接受治疗和成对眼的患者。在3个月时，研究组和对照组之间的平均ECC变化百分比与基线相比无统计学差异（-5.55％对-6.66％；平均差异1.11％±11.89％[SD]； 95％置信区间（ CI）-0.52至2.74）或IOP累计尖峰率（8.2％对6.3％;平均百分比差-1.9％; 95％CI，-5.46％至1.61％）。在3个月时，两个OVD组的IOP均较基线水平显着降低（分别为-1.37 mm Hg和-1.32 mm Hg；两个均P  <.0001）。两组之间的水肿，炎症，严重不良事件和视力结果的分布也相似。

结论

2种OVD在白内障手术的安全性和有效性方面在临床上相似。