Safety And Clinical Outcomes Of The Gore Synthetic Cornea: First-In-Human Clinical Trial 18-Month Results

To evaluate anatomic retention, safety profile, and clinical outcomes of the Gore Synthetic Cornea Device. This prospective, first-in-human, single-arm clinical trial was conducted at the Instituto de Oftalmología Fundación Conde de Valenciana IAP, Mexico City. The study adhered to the tenets of the Declaration of Helsinki and was approved by institutional ethics and research committees. Written informed consent was obtained from all participants.

Patients with advanced corneal opacity secondary to corneal edema and reasonable potential for visual rehabilitation were included. The Gore Synthetic Cornea Device consists of a soft fluoroelastomer optic and a porous expanded polytetrafluoroethylene (ePTFE) skirt designed to promote host tissue biointegration

Devices were implanted using a partial-thickness lamellar stromal pocket technique. Adequate implantation depth was defined as ≥350 µm. Baseline demographics and ocular history were recorded. Postoperative evaluations included slit-lamp examination, best-corrected visual acuity (BCVA), intraocular pressure (IOP), anterior segment OCT, Humphrey visual field testing, and macular and optic nerve OCT. Primary outcome measures were device retention, visual acuity, and complications at 18 months. Seven eyes of seven patients were enrolled and successfully implanted with the Gore device (71% female; mean age 67.4 ± 13.4 years). Indications included prior graft failure (n=4, 57.1%) and pseudophakic bullous keratopathy (n=3, 42.9%). 

At 18 months, 5/7 eyes (71.4%) retained the device. Two devices required early explantation due to infectious keratitis related to superficial implantation. Functional success (BCVA ≥20/200) was achieved in all retained eyes, with a mean BCVA of 0.55 ± 0.27 logMAR (≈20/70). Epithelialization over the device surface was observed in all retained cases, consistent with host–device biointegration. Perioptic corneal retraction was the most common complication and was stabilized with secondary interventions. After device and surgical refinements, including reduced thickness, optic flaring, and femtosecond-assisted pocket creation, retention improved to 100% in four patients at 3 months (BCVA 0.43 ± 0.28 logMAR, ≈20/50).

The Gore Synthetic Cornea Device provided meaningful visual rehabilitation and demonstrated promising anatomic retention with evidence of host biointegration. The absence of severe inflammation or glaucoma-related adverse events supports the biocompatibility of the materials. Early device design and surgical refinements aimed at promoting stable epithelial coverage and a continuous biological seal were associated with improved short-term retention and visual outcomes. These findings provide first-in-human proof of concept for a donor-independent keratoprosthesis with the potential to restore vision and expand access to corneal surgery worldwide.