Robot-assisted full-thickness corneal transplant
Official title: Graft Robot-Assisted Corneal Enhancement
Run by CHU de Reims · NCT06844123 · Data updated 2026-11-12
This will try using a surgical robot to help surgeons perform full-thickness corneal transplants for adults with severe corneal dystrophy who need a graft.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | CHU de Reims Academic / other |
| Locations | 1 site (Reims) |
| Status | Recruiting |
| Started | June 6, 2025 |
| Main results expected | June 2026 |
| Study ends | April 2027 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT06844123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults seen at Reims University Hospital who require transfixing keratoplasty for severe corneal disease, are affiliated with social security, and can provide informed consent are the intended participants.
✕Probably not a fit
Patients with other significant ocular pathology, those legally protected or unable to consent, and patients who can be managed without full-thickness grafting are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional program at Reims University Hospital uses a microsurgical robotic system (Symani®) to assist surgeons during transfixing keratoplasty, the full-thickness corneal graft procedure. The robot provides fine forceps and a needle holder with motion scaling to handle fragile tissues and place sutures with high precision. Procedures are performed under general anesthesia with standard postoperative topical immunomodulatory therapy and routine follow-up for suture removal and visual recovery. Eligible adult patients who require a full-thickness graft and can give informed consent will undergo robot-assisted suturing to collect safety and anatomical outcome data.
Why it matters
Potential benefit: If successful, robot-assisted suturing could improve graft edge alignment and reduce postoperative astigmatism, potentially speeding visual recovery.
How similar studies have gone: While robot-assisted surgery is well established in other surgical specialties, robot use for corneal transplantation is novel and supported mainly by early feasibility reports rather than large-scale trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
inclusion criteria : * 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). exclusion criteria : * Patients protected by law * Patients with an ocular pathology other than their corneal pathology. * Mentally incapable of adhering to the principles of the study.
Where it's running
-
Chu Reims
Reims, France Recruiting
Study contacts
- Study coordinator: Alexandre DENOYER
- Email: adenoyer@chu-reims.fr
- Phone: 0326787888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.