Matteucci Andrea, Formisano Giuseppe, Paradisi Silvia, Carnovale-Scalzo Giovanna, Scorcia Giovanni, Caiazza Salvatore, Hoerauf Hans, Malchiodi-Albedi Fiorella
G.B. Bietti Foundation for Ophthalmology (I.R.C.C.S.), Rome, Italy.
Surv Ophthalmol. 2007 May-Jun;52(3):289-99. doi: 10.1016/j.survophthal.2007.02.004.
The biocompatibility of liquid artificial vitreous replacements is generally assessed by performing tests in animal models before their clinical use, whereas in vitro experimentation is seldom carried out due to their physico-chemical characteristics. Since their introduction in vitreoretinal surgery, however, the use of some certified vitreous replacements has been discouraged after clinical trials, because of the occurrence of serious side effects. This observation suggests that the tests currently performed for biocompatibility assessment cannot fully guarantee their safety when they are used in humans. Here we review the available literature on in vitro biocompatibility testing of liquid artificial vitreous replacements and survey our own experience on the subject, obtained by using primary retinal cell cultures, seeded on micro-porous inserts. We suggest that in vitro biocompatibility assessment, conducted before experiments in animal models, could improve the required safety evaluation and decrease the risk of undesired side effects, as well as providing a beneficial reduction of animal experimentation.
液体人工玻璃体替代物的生物相容性通常在临床应用前通过在动物模型中进行测试来评估,然而,由于其物理化学特性,很少进行体外实验。自其被引入玻璃体视网膜手术以来,一些经过认证的玻璃体替代物在临床试验后因出现严重副作用而不再被鼓励使用。这一观察结果表明,目前用于生物相容性评估的测试在用于人体时不能完全保证其安全性。在这里,我们回顾了关于液体人工玻璃体替代物体外生物相容性测试的现有文献,并总结了我们自己在这一主题上的经验,这些经验是通过使用接种在微孔插入物上的原代视网膜细胞培养物获得的。我们建议,在动物模型实验之前进行体外生物相容性评估,可以改进所需的安全性评估,降低出现不良副作用的风险,同时有助于减少动物实验。