Abstract：
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 in vitro and in vivo.
A human-like pars plana vitrectomy was performed on porcine eyes ex vivo, 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 in vitro cytotoxicity tests and in vivo 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 in vitro and in vivo 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.
A human-like pars plana vitrectomy was performed on porcine eyes ex vivo, 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 in vitro cytotoxicity tests and in vivo 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 in vitro and in vivo 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.
摘要：
■用于眼内使用的理想染料应有效地将目标组织染色，同时易于施加和去除。此外,它不应该有任何副作用导致与视网膜组织长期接触。最近,人们对某些活体染料在外科手术过程中的安全性提出了担忧，因为它们可能会穿过内界膜并沉积在视网膜上。在这项研究中,我们的目的是调查是否市售的至关重要的染料，VIEW-ILM®和TWIN®(AL.CHI.MI.A.S.r.l.,PonteSanNicoló,帕多瓦,意大利),在玻璃体视网膜手术期间有可能穿过内界膜并沉积在视网膜上。此外，我们在体外和体内评估了它们的安全性。
■在离体的猪眼睛上进行了类似人的平坦部玻璃体切除术，使用VIEW-ILM®或TWIN®对内部限制膜进行染色，有或没有随后的内部限制膜剥离。然后从有或没有内界膜的视网膜穿孔中提取两种染料，并使用高效液相色谱法进行定量。根据ISO标准,通过体外细胞毒性试验和体内皮肤致敏和刺激试验评价安全性。
高效液相色谱分析表明,VIEW-ILM®和TWIN®有效地染色内界膜而不穿过膜。去除内界膜后，在视网膜层中没有发现残留的染料。此外，体外和体内安全性测试均证实不存在细胞毒性，皮肤致敏,和刺激。
■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体染料的特性。
■在离体的猪眼睛上进行了类似人的平坦部玻璃体切除术，使用VIEW-ILM®或TWIN®对内部限制膜进行染色，有或没有随后的内部限制膜剥离。然后从有或没有内界膜的视网膜穿孔中提取两种染料，并使用高效液相色谱法进行定量。根据ISO标准,通过体外细胞毒性试验和体内皮肤致敏和刺激试验评价安全性。
高效液相色谱分析表明,VIEW-ILM®和TWIN®有效地染色内界膜而不穿过膜。去除内界膜后，在视网膜层中没有发现残留的染料。此外，体外和体内安全性测试均证实不存在细胞毒性，皮肤致敏,和刺激。
■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体染料的特性。
