Instituto Universitario de Oftalmobiología Aplicada (IOBA), Eye Institute, University of Valladolid, Valladolid, Spain.
Red Temática de Investigacion Cooperativa en Salud de Oftalmologia (Oftared), Instituto de Salud Carlos III, Madrid, Spain.
Br J Ophthalmol. 2019 Jan;103(1):49-54. doi: 10.1136/bjophthalmol-2017-311471. Epub 2018 Mar 29.
To report new information related to acute retinal toxicity of Bio Octane Plus, a mixture of 90% perfluorooctane (PFO) and 10% perfluorohexyloctane.
This retrospective, descriptive case series reports the occurrence of acute retinal toxicity after vitreoretinal surgery in which Bio Octane Plus (batch number 1605148) was used as an endotamponade. Cytotoxicity biocompatibility tests and chemical analyses by Fourier-transformed infrared (FTIR) spectroscopy and gas chromatography-mass spectrometry (GC-MS) of the presumed toxic product were performed.
Four patients presented with acute severe visual loss after uneventful ocular surgery assisted by Bio Octane Plus (batch number 1605148) as endotamponade. Patients experienced extensive retinal vascular occlusion leading to retinal and optic nerve atrophy. The viability of ARPE-19 cells directly exposed to the suspect batch for 30 min was 0%. The agarose overlay method used by the manufacturer according to European Union regulations and International Organization for Standardization (ISO) International Standards failed to detect toxicity. FTIR spectroscopy showed small differences between the non-toxic and toxic batches. GC-MS analysis showed the presence of bromotributyl stannane (whose toxicity was demonstrated in the dose-response curve) only in the toxic batch of Bio Octane Plus.
This is the third report of retinotoxicity due to PFO in 4 years. The clinical profiles may be missed as they resemble other postsurgical complications; therefore, more cases worldwide could have gone unreported. Protocols to determine cytotoxicity of intraocular medical devices and approved by the ISO International Standards based on indirect methods have failed and should be revised to ensure safety.
报告与 Bio Octane Plus（一种 90%全氟辛烷（PFO）和 10%全氟己基辛烷的混合物）急性视网膜毒性相关的新信息。
本回顾性描述性病例系列报告了在使用 Bio Octane Plus（批号 1605148）作为眼内填充物的玻璃体视网膜手术后发生急性视网膜毒性的情况。对疑似毒性产物进行细胞毒性生物相容性测试和傅里叶变换红外（FTIR）光谱及气相色谱-质谱（GC-MS）化学分析。
4 名患者在接受无并发症的眼部手术并使用 Bio Octane Plus（批号 1605148）作为眼内填充物后，出现急性严重视力丧失。患者出现广泛视网膜血管阻塞，导致视网膜和视神经萎缩。直接暴露于可疑批次 30 分钟的 ARPE-19 细胞存活率为 0%。制造商根据欧盟法规和国际标准化组织（ISO）国际标准使用的琼脂糖覆盖法未能检测到毒性。FTIR 光谱显示无毒和有毒批次之间存在微小差异。GC-MS 分析显示，只有在有毒的 Bio Octane Plus 批次中才存在溴化三丁基锡（其毒性已在剂量反应曲线上得到证实）。
这是 4 年内第 3 次报告与 PFO 相关的视网膜毒性。由于其临床表现类似于其他手术后并发症，因此可能会漏诊；因此，全球可能有更多未报告的病例。基于间接方法并经 ISO 国际标准批准的用于确定眼内医疗器械细胞毒性的方案已经失败，应进行修订以确保安全性。
