Actively Recruiting
Graft Robot-Assisted Corneal Enhancement for Corneal Transplantation Using the Symani4 Microsurgical System
Led by CHU de Reims · Updated on 2025-06-26
10
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
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 graft's 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.
CONDITIONS
Brief Title
Microsurgical Robot-assisted Corneal Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of legal age seen in a specialized ophthalmology consultation at the Reims University Hospital, and requiring transfixing keratoplasty.
- Affiliated to a social security scheme
- Agreeing to take part in the study (information and signature of consent form).
You will not qualify if you...
- Patients protected by law
- Patients with an ocular pathology other than their corneal pathology.
- Mentally incapable of adhering to the principles of the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (surgery day)
Participants undergo robot-assisted corneal transplantation using a microsurgical robot to perform the corneal sutures under general anesthesia.
1 surgical visit (in-person)
Duration - Up to 90 days after surgery
Participants are monitored clinically to assess recovery and any early or late postoperative events.
Visits on Day 1, Day 7, Day 30, and Day 90 (all in-person)
Trial Site Locations
Total: 1 location
1
Chu Reims
Reims, France, 51092
Actively Recruiting
Research Team
A
Alexandre DENOYER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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