Colin J, Renard G, Ullern M, Lablache Combier M, Richard C, Trinquand C
Hôpital Morvan, Brest.
J Fr Ophtalmol. 1995;18(5):356-63.
The goal of this trial was to evaluate the efficacy (protective action on corneal endothelium and ability to facilitate the procedure) as well as safety (effect on intraocular pressure and inflammation) of Biovisc (new viscoelastic agent made of 1% sodium hyaluronate produced by bacterial fermentation) versus Healonid) postcataract surgery (manual or phacoemulsification).
106 patients, 45 males and 61 females (31-94 years) were included in this prospective randomized multicentre trial and followed up for three months. Specular microscopy and intraocular pressure (IOP) measurement were the main evaluation criteria.
At D 90, no significant difference was observed between the two viscoelastic agents on the mean endothelial cell loss (group Viovis: -8.6%; group Healonid: -6%) as well as on IOP (early peaks were transitory and resolutive).
Biovisc and Healonid were similar in terms of efficacy and tolerance.
本试验的目的是评估Biovisc（一种由细菌发酵产生的1%透明质酸钠制成的新型粘弹性剂）与Healonid相比，在白内障手术后（手动或超声乳化）的疗效（对角膜内皮的保护作用及促进手术的能力）以及安全性（对眼压和炎症的影响）。
106例患者，45例男性和61例女性（31 - 94岁）纳入了这项前瞻性随机多中心试验，并随访3个月。镜面显微镜检查和眼压（IOP）测量是主要评估标准。
在第90天时，两种粘弹性剂在平均内皮细胞损失（Viovis组：-8.6%；Healonid组：-6%）以及眼压方面（早期峰值是短暂的且可消退）均未观察到显著差异。
Biovisc和Healonid在疗效和耐受性方面相似。
