Rodrigues Eduardo B, Shiroma Helio, Penha Fernando M, Maia Mauricio, Moraes-Filho Milton N, Ferreira Magno, Portella Renata, Novais Eduardo, Hagedorn Nadine, Farah Michel E
Vision Institute (IPEPO), Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.
Retina. 2014 Jun;34(6):1103-11. doi: 10.1097/IAE.0000000000000078.
To present the development and initial experience of a novel colored perfluorocarbon liquid (PFCL) in vitreoretinal surgery.
This was an experimental laboratory study and prospective human interventional study. F6H8 (Fluoron GmbH) was colored by adding 0.3 g/L blue anthraquinone dye. Subsequently, 20% colored F6H8 was prepared by mixing with perfluorooctane or perfluorodecalin (Fluoron GmbH). The novel product is not yet FDA approved for human application. In the laboratory, the colored PFCL was covered with 1) uncolored PFCL, 2) BSS, and 3) silicone oil. Cell toxicity was evaluated in L929 mouse fibroblasts using a growth inhibition assay. Porcine ex vivo eyes were evaluated after vitrectomy followed by intravitreal and subretinal colored PFCL infusion. A pilot, prospective, noncomparative interventional study was conducted in patients with retinal detachment with proliferative vitreoretinopathy (PVR).
The density of the colored PFLC mixture was 1.664 g/cm for perfluorooctane and 1.802 g/cm for perfluorodecalin. There was no relevant cell growth inhibition with any concentration of colored PFCL tested. Experiments in pigs revealed that infusion of the colored PFCL caused neither staining of the internal limiting membrane nor intravitreal residual droplets. In the prospective study, 9 eyes (75%) underwent surgery for rhegmatogenous retinal detachment with at least grade C PVR. The colored PFCL enabled retinal break examination and detection of residual intravitreal droplets in all surgeries. There was no case of separation or leakage of the dye from the PFCL solution that could have caused unwanted staining of the vitreous or epiretinal surface.
The colored PFCL enabled intraoperative maneuvers such as endolaser use. In addition, removal of the colored PFCL was easily achieved at the end of surgery.
介绍一种新型彩色全氟碳液体（PFCL）在玻璃体视网膜手术中的研发及初步经验。
这是一项实验性实验室研究和前瞻性人体干预研究。通过添加0.3 g/L蓝色蒽醌染料对F6H8（Fluoron GmbH公司）进行染色。随后，将其与全氟辛烷或全氟萘烷（Fluoron GmbH公司）混合制备出20%的彩色F6H8。该新型产品尚未获得美国食品药品监督管理局（FDA）批准用于人体。在实验室中，彩色PFCL分别用1）无色PFCL、2）平衡盐溶液（BSS）和3）硅油覆盖。使用生长抑制试验在L929小鼠成纤维细胞中评估细胞毒性。在猪的离体眼中进行玻璃体切除术后，向玻璃体内和视网膜下注入彩色PFCL并进行评估。对患有增生性玻璃体视网膜病变（PVR）的视网膜脱离患者进行了一项先导性、前瞻性、非对照干预研究。
彩色PFLC混合物的密度，全氟辛烷为1.664 g/cm³，全氟萘烷为1.802 g/cm³。所测试的任何浓度的彩色PFCL均未产生相关的细胞生长抑制。在猪身上进行的实验表明，注入彩色PFCL既不会导致内界膜染色，也不会在玻璃体内残留液滴。在前瞻性研究中，9只眼（75%）接受了手术治疗孔源性视网膜脱离，至少为C级PVR。彩色PFCL在所有手术中都能用于视网膜裂孔检查和检测玻璃体内残留液滴。没有发生染料从PFCL溶液中分离或泄漏的情况，从而不会导致玻璃体或视网膜前表面出现不必要的染色。
彩色PFCL可实现术中操作，如使用眼内激光。此外，在手术结束时很容易将彩色PFCL清除。
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