The Ocular Surface Disease Clinic, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Transl Vis Sci Technol. 2023 Aug 1;12(8):9. doi: 10.1167/tvst.12.8.9.
To report the biological stability and postoperative outcomes of a second-generation, single-piece, flexible synthetic cornea in a rabbit model.
Device materials and design were amended to enhance biointegration. Optic skirt design devices were made from compact perfluoroalkoxy alkane with porous expanded polytetrafluoroethylene ingrowth surface overlying the skirt and optic wall. Sixteen devices were implanted into intrastromal pocket in rabbit eyes. Rabbits were randomly assigned to 6- and 12-month follow-up cohorts (n = 8 in each) postoperatively. Monthly examinations and optical coherence tomography assessed cornea-device integration, iridocorneal angle, optic nerve, and retina.
There were no intraoperative complications. All devices were in situ at exit, with clear optics. No retroprosthetic membrane, glaucoma, cataract formation, or retinal detachment was observed. Two rabbits in the 6-month group had mild, focal anterior lamella thinning without retraction adjacent to the optic near tight sutures. Three postoperative complications occurred in the 12-month group. One rabbit diagnosed with endophthalmitis was euthanized on day 228. Mild sterile focal retraction of anterior lamella occurred in two rabbits, which were terminated on days 225 and 315. Light microscopic examination of enucleated globes demonstrated fibroplasia with new collagen deposition into the porous scaffold without significant inflammation, encapsulation, or granuloma formation.
Clinical evaluations, imaging, and histopathological findings indicate favorable outcomes of this synthetic corneal device in a rabbit model. Early feasibility studies in humans are being planned.
Favorable 12-month results of the device in rabbits demonstrate vision-restoring potential in corneally blind individuals at high risk of failure with donor keratoplasty.
报道一种第二代单片式软性合成角膜在兔模型中的生物稳定性和术后结果。
对设备材料和设计进行了改进，以增强生物整合性。光学裙边设计装置由致密的全氟烷氧基烷烃制成，裙边和光学壁上方覆盖有多孔膨体聚四氟乙烯生长表面。将 16 个装置植入兔眼的基质袋内。术后，兔子被随机分配到 6 个月和 12 个月的随访队列（每组 n = 8）。每月检查和光学相干断层扫描评估角膜-器械整合、虹膜角膜角、视神经和视网膜。
术中无并发症。所有器械均在位，光学清晰。未观察到后弹力膜、青光眼、白内障形成或视网膜脱离。6 个月组中有 2 只兔子轻度、局灶性前板层变薄，紧邻光学紧密缝线处无回缩。12 个月组中有 3 只兔子发生术后并发症。1 只诊断为眼内炎的兔子在第 228 天被安乐死。2 只兔子出现轻度无菌性局限性前板层回缩，分别于第 225 天和第 315 天终止。眼球摘出后的光镜检查显示，新胶原沉积在多孔支架内形成纤维增生，无明显炎症、包裹或肉芽肿形成。
临床评估、影像学和组织病理学检查结果表明，该合成角膜装置在兔模型中具有良好的效果。目前正在计划对人类进行早期可行性研究。
陈昊
