Robot-Assisted Full-Thickness Corneal Transplant Surgery in Adults with Corneal Disease

What this Trial Is About

Researchers are evaluating the use of a microsurgical robot called the Symani4 surgical system for full-thickness corneal grafting, also known as transfixing keratoplasty. This procedure replaces the central part of the cornea in patients with severe corneal disease affecting vision, where no other treatment options exist. The study aims to see if robot-assisted surgery can match or improve the crucial suturing step, which affects the grafts curvature and visual outcome, while also assessing surgical costs. The study involves adult patients requiring corneal transplantation who will undergo robot-assisted keratoplasty using the Symani4 robot. This robot is operated by a surgeon via a wireless controller and foot pedal to perform delicate corneal sutures. The procedure is done under general anesthesia with an operating microscope. Patients will have follow-up visits on Days 1, 7, 30, and a final assessment on Day 90 after surgery. Participants will be monitored for any unusual events during and after surgery, corneal anatomical results, visual acuity with and without correction, corneal shape regularity, and subjective refraction. Quality of life will be assessed before and three months after surgery. Surgical costs will also be analyzed six months post-procedure. The study will last about 3 months per participant, including clinical and paraclinical follow-ups to evaluate safety and surgical outcomes.

Microsurgical Robot-assisted Corneal Transplant