Schrage N, Cordes A K, Storsberg J, Sel S, Röthgen H, Nass N, Berndt E, Jockenhövel S, Meßner A, Panfil C
Aachener Centrum für Technologietransfer in der Ophthalmologie, Aachen, Deutschland,
Ophthalmologe. 2014 Mar;111(3):247-53. doi: 10.1007/s00347-013-2871-5.
Clinical application of a keratoprosthesis (KPRO) is still a challenging task. Recent developments reflect the concepts of nut and bolt, intrastromal implantation or an osteoodontokeratoprosthesis (OOKP). A new concept of a textile KPRO has been evaluated in a limited human study with considerable difficulties which after termination of the study and considerable improvements was restarted using animal experiments.
The ACTO TexKPRO is made from polyvinylidene difluoride (PVDF) fibers and transparent silicone. The first and second developmental stages differed in density and size of fibers and furthermore in surface modifications of the fibers and optics which were improved for the second prototype.
Implantation of the prosthesis was performed in four patients with corneal blindness and in two cases retinal disease which required surgery. In the later animal experiments surgery was performed on three rabbits. Surgery was performed by redressing the conjunctiva, opening of the eyeball with a central 6.5 mm trephination, removal of the lens and iris and implantation and suturing of the TexKPRO. If required a silicone oil endotamponade was placed.
All eyes were stable with the keratoprosthesis. The first prototype showed conjunctival recession on the textile haptics with highly susceptible endopthalmitis risk due to infection of the PVDF so that we decided to remove the prosthesis from all eyes after one case of severe endophthalmitis occurred. The longest time of placement was 40 months and the shortest time 6 months. All eyes were restored by keratoplasty. In animals with the new haptic we found better conjunctivalization and stable implantation of the KPRO.
The textile KPRO provides a stable implantation procedure and safe connection of fibers to the scleral wound bed. The optical and mechanical implantation is safe and stable. Surface epithelialization is improved with the new surface modifications and different PVDF fiber density but beforel new implantations are planned further conceptual changes will be introduced.
角膜移植术（KPRO）的临床应用仍然是一项具有挑战性的任务。最近的进展反映了螺母和螺栓、基质内植入或骨牙角膜移植术（OOKP）的概念。一种新型纺织角膜移植术的概念已在一项有限的人体研究中进行了评估，但遇到了相当大的困难。在研究终止并取得显著改进后，通过动物实验重新启动了该研究。
ACTO TexKPRO由聚偏二氟乙烯（PVDF）纤维和透明硅胶制成。第一和第二开发阶段在纤维的密度和尺寸上有所不同，此外在纤维的表面改性和光学性能方面也有所不同，第二个原型在这些方面得到了改进。
在4例角膜盲患者和2例需要手术的视网膜疾病患者中植入了该假体。在后来的动物实验中，对3只兔子进行了手术。手术通过修整结膜、用6.5毫米中心环钻打开眼球、摘除晶状体和虹膜以及植入和缝合TexKPRO来进行。如有需要，放置硅油内填塞物。
所有植入角膜移植术的眼睛均保持稳定。第一个原型在纺织触觉装置上出现结膜退缩，由于PVDF感染，发生眼内炎的风险很高，因此在发生一例严重眼内炎后，我们决定从所有眼睛中取出假体。放置时间最长为40个月，最短为6个月。所有眼睛均通过角膜移植术得以恢复。在使用新型触觉装置的动物中，我们发现结膜化更好，角膜移植术的植入也更稳定。
纺织角膜移植术提供了稳定的植入程序以及纤维与巩膜伤口床的安全连接。光学和机械植入安全且稳定。新的表面改性和不同的PVDF纤维密度改善了表面上皮化，但在计划进一步的新植入之前，还将引入更多概念上的改变。
