Matet Alexandre, Amar Nawel, Mohand-Said Saddek, Sahel José-Alain, Barale Pierre-Olivier
INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision.
INSERM and DHOS, CHNO des Quinze-Vingts; Sorbonne Universités, UPMC Univ Paris 6, Institut de la Vision; INSERM; CNRS, Paris, France.
Clin Ophthalmol. 2016 Aug 18;10:1565-71. doi: 10.2147/OPTH.S112403. eCollection 2016.
The Argus II retinal prosthesis is composed of an epiretinal electrode array positioned over the macula and connected to an extrascleral electronics case via a silicone cable, running through a sclerotomy. During implantation, the manufacturer recommends to cover the sclerotomy site with a patch of processed human pericardium to prevent postoperative hypotony and conjunctival erosion by the underlying electronics case. Due to biomedical regulations prohibiting the use of this material in France, we developed an alternative technique combining a scleral flap protecting the sclerotomy and an autogenous graft of superior temporalis fascia overlying the electronics case.
The purpose of this study is to describe the 4-year outcomes of this modified procedure in three subjects who underwent Argus II Retinal Prosthesis System implantation. Clinical data consisting of intraocular pressure measurements and tolerance in terms of conjunctival erosion or inflammation were retrospectively assessed over a 4-year postoperative follow-up.
None of the three patients implanted with the modified technique developed ocular hypotony over 4 years. A normal, transient conjunctival inflammation occurred during the first postoperative month but conjunctival erosion was not observed in any of the three patients over 4 years. Four years after implantation, the autogenous temporalis fascia graft remained well tolerated and the retinal prosthesis was functional in all three patients.
The combination of an autograft of superficial temporalis fascia and a scleral flap efficiently prevented leakage through the sclerotomy site, ocular hypotony, and conjunctival erosion by the extrascleral electronics case. This modified technique is suitable for the implantation of existing and forthcoming retinal prostheses. Superficial temporalis fascia may also be used as alternative to commercial tectonic tissues for scleral wound repair in clinical settings where they are not available.
阿格斯II型视网膜假体由置于黄斑上方的视网膜外电极阵列组成，通过一根硅酮电缆穿过巩膜切开处与巩膜外电子盒相连。在植入过程中，制造商建议用一片经过处理的人心包覆盖巩膜切开部位，以防止术后低眼压以及巩膜外电子盒导致的结膜糜烂。由于生物医学法规禁止在法国使用这种材料，我们开发了一种替代技术，将保护巩膜切开处的巩膜瓣和覆盖在电子盒上的颞肌上筋膜自体移植物相结合。
本研究的目的是描述三名接受阿格斯II型视网膜假体系统植入的受试者采用这种改良手术的4年结果。在术后4年的随访中，对包括眼压测量以及结膜糜烂或炎症方面的耐受性在内的临床数据进行回顾性评估。
采用改良技术植入的三名患者在4年中均未出现低眼压。术后第一个月出现了正常的短暂结膜炎症，但三名患者在4年中均未观察到结膜糜烂。植入4年后，颞肌筋膜自体移植物耐受性良好，三名患者的视网膜假体均功能正常。
颞肌浅筋膜自体移植与巩膜瓣相结合有效地防止了巩膜切开部位的渗漏、低眼压以及巩膜外电子盒导致的结膜糜烂。这种改良技术适用于现有和即将出现的视网膜假体的植入。在没有商业性结构性组织的临床环境中，颞肌浅筋膜也可作为巩膜伤口修复的替代材料。
