Surgical Considerations for the Human Implantation of the Gore Synthetic Corneal Device.

Purpose: To describe the surgical technique for implantation of a novel flexible, suturable, intrastromal synthetic cornea device.

Methods: This report is a description of a novel surgical technique. Adult patients (≥18 years) with corneal edema who met specific inclusion criteria were enrolled. Intraoperative anterior segment optical coherence tomography was used to guide the surgery. The surgical procedure was performed under general anesthesia, utilizing a modified intrastromal pocket technique for secure implantation. First, a 4-mm partial-thickness trephination was created using a hand-held disposable metal trephine, followed by the manual dissection of a 360-degree intrastromal lamellar pocket at midstromal depth. After having completed the full-thickness trephination, the corneal button was removed and the device was carefully inserted into the pocket, rotated for proper positioning with the optical stem extending full thickness within the trephination wound and the skirt secured within the stromal pocket using 16 interrupted 10-0 nylon sutures.

Results: A total of 8 surgeries were initiated. The procedure had to be aborted in only one patient because of anterior perforation of the cornea. Seven surgeries were completed satisfactorily without complications. Intraoperative AS-OCT confirmed the correct positioning of the device within the corneal stromal pocket and excellent apposition of the optical stem within the trephination wound.

Conclusions: The intrastromal pocket implantation technique provides secure fixation and proper centration of this novel synthetic cornea device. The flexibility and suturability of the device eliminate the need for a carrier donor cornea.