The Wilmer Eye Institute, Ocular Surface Diseases Clinic, The Johns Hopkins University Medical School, Baltimore, MD; and.
W.L. Gore & Associates, Inc., Newark, DE.
Cornea. 2020 Jun;39(6):706-712. doi: 10.1097/ICO.0000000000002266.
To evaluate the clinical performance and biocompatibility of a novel synthetic corneal device.
Synthetic, single-piece, foldable, suturable, optic-and-skirt design prototype devices were fabricated using expanded polytetrafluoroethylene. A combination of intralamellar and full-thickness penetrating techniques was used for implantation. A topical antibiotic-steroid regimen was used postoperatively. Rabbits were examined weekly using penlight and at monthly intervals under an operating microscope with integrated optical coherence tomography. Optical quality, retention, and complication rates at 3 and 6 months were assessed.
Nineteen rabbits underwent surgery. There were no device-related intraoperative complications. Creation of lamellar pocket was problematic in 2 younger rabbits with inadequate chamber depth. Two rabbits had early postoperative infectious keratitis attributed to bandage contact lens wear, which was ceased. Rabbits were treated using fourth-generation fluoroquinolone drops and did well over a period of 6 months without device extrusion or further complications. Four other rabbits had late postoperative infectious keratitis because of exposed suture(s), which progressed to endophthalmitis. One rabbit had sterile keratolysis and retraction of the anterior corneal lamella. There was no retinal detachment, glaucoma, anterior or posterior synechiae, or cataract formation in any of the rabbits. All devices remained in situ with clear optics without spoliation. Light microscopic examination of the globes demonstrated intact epithelium overlying the skirt and new collagen integration into the porous structure of the skirt without significant inflammation.
Our results demonstrated favorable short-term anatomical clinical outcomes of this novel synthetic corneal prosthesis. Further studies are warranted to characterize the biointegration of this device.
评估一种新型合成角膜装置的临床性能和生物相容性。
使用膨化聚四氟乙烯制造合成、单片、可折叠、可缝合、光学和裙边设计的原型设备。采用层间和全厚度穿透技术进行植入。术后使用局部抗生素-类固醇治疗。每周使用检眼镜和每月一次在集成光学相干断层扫描的手术显微镜下检查兔子。评估术后 3 个月和 6 个月时的光学质量、保留率和并发症发生率。
19 只兔子接受了手术。没有与设备相关的术中并发症。在 2 只年轻兔子中，由于房深度不足，制作层间袋有问题。2 只兔子在术后早期因绷带接触镜佩戴而发生感染性角膜炎，停止了佩戴。兔子使用第四代氟喹诺酮滴眼液进行治疗，在 6 个月的时间内恢复良好，没有发生设备脱出或进一步的并发症。另外 4 只兔子由于暴露的缝线而发生晚期术后感染性角膜炎，导致眼内炎。1 只兔子发生无菌性角膜溶解和前角膜层回缩。没有任何一只兔子发生视网膜脱离、青光眼、前后粘连或白内障形成。所有装置均原位保留，光学清晰，无损坏。眼球的光镜检查显示，上皮完整地覆盖在裙边上，新的胶原整合到裙边的多孔结构中，没有明显的炎症。
我们的结果表明，这种新型合成角膜假体具有良好的短期解剖临床结果。需要进一步的研究来描述该设备的生物整合。
