Gatto Claudio, Giurgola Laura, Rodella Umberto, Rossi Orietta, Honisch Claudia, Ruzza Paolo, Ragazzi Eugenio, D'Amato Tóthová Jana
Research and Development, AL.CHI.MI.A. S.r.l, Ponte San Nicolò, Italy.
Institute of Biomolecular Chemistry of CNR, Padua Unit, Padua, Italy.
Curr Eye Res. 2024 Jun;49(6):615-623. doi: 10.1080/02713683.2024.2309248. Epub 2024 Feb 16.
An ideal dye for intraocular use should effectively stain the target tissue while being easy to apply and remove. Additionally, it should not have any adverse effects resulting from prolonged contact with the retinal tissue. Recently, concerns have been raised about the safety of some vital dyes during surgical procedures as they may cross the internal limiting membrane and deposit on the retina. In this study, we aimed to investigate whether commercially available vital dyes, VIEW-ILM® and TWIN® (AL.CHI.MI.A. S.r.l., Ponte San Nicolò, Padova, Italy), have the potential to cross the internal limiting membrane during vitreoretinal surgery and deposit on the retina. Furthermore, we evaluated their safety and .
A human-like pars plana vitrectomy was performed on porcine eyes , with VIEW-ILM or TWIN used to stain the internal limiting membrane either with or without subsequent internal limiting membrane peeling. The two dyes were then extracted from retinal punches with or without internal limiting membrane, and quantified using high performance liquid chromatography. Safety was evaluated through cytotoxicity tests and skin sensitization and irritation tests according to ISO standards.
High performance liquid chromatography analyses demonstrated that VIEW-ILM and TWIN effectively stained the internal limiting membrane without crossing the membrane. No residual dyes were found in the retinal layers after internal limiting membrane removal. Furthermore, both and safety tests confirmed the absence of cytotoxicity, skin sensitization, and irritation.
The results of this study support the safety and efficacy of VIEW-ILM and TWIN for internal limiting membrane staining. The experimental protocol described in this study could be utilized to gain a comprehensive understanding of the characteristics of vital dyes.
理想的眼内用染料应能有效染色目标组织，同时易于应用和去除。此外，它不应因与视网膜组织长时间接触而产生任何不良反应。最近，人们对一些活性染料在手术过程中的安全性表示担忧，因为它们可能穿过内界膜并沉积在视网膜上。在本研究中，我们旨在调查市售活性染料VIEW-ILM®和TWIN®（意大利帕多瓦圣尼科洛桥的AL.CHI.MI.A. S.r.l.公司）在玻璃体视网膜手术期间是否有可能穿过内界膜并沉积在视网膜上。此外，我们评估了它们的安全性。
对猪眼进行类似人类的经平坦部玻璃体切除术，使用VIEW-ILM或TWIN对有或没有随后的内界膜剥离的内界膜进行染色。然后从有或没有内界膜的视网膜组织块中提取这两种染料，并使用高效液相色谱法进行定量。根据ISO标准，通过细胞毒性试验以及皮肤致敏和刺激试验评估安全性。
高效液相色谱分析表明，VIEW-ILM和TWIN有效地染色了内界膜，且未穿过该膜。去除内界膜后，视网膜各层未发现残留染料。此外，细胞毒性和安全性测试均证实不存在细胞毒性、皮肤致敏和刺激现象。
本研究结果支持VIEW-ILM和TWIN用于内界膜染色的安全性和有效性。本研究中描述的实验方案可用于全面了解活性染料的特性。
