PURPOSE: To evaluate the clinical performance and biocompatibility of a novel synthetic corneal device. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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