NCT02116062

Robotic Surgery of the Ocular Surface

Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The introduction of surgical robots in the OR revolutionized a number of specialties (i. e. urology, gynecology, digestive surgery). Robots are currently used in many situations and the list of appropriate indications is growing rapidly. There are many potential advantages of robotics in eye surgery such as increased precision and maneuverability, better ergonomics, improved patient access to surgeons and surgical training. As a result, robotics might improve patient care. The Da Vinci© robot has been used for 10 years in experimental conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from poor visualization and the absence of microsurgical instruments. These elements were considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has been available since 2009 at the IRCAD center and more recently in Strasbourg University Hospital. It provides greater magnification and better resolution of the operative field than the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with the Da Vinci Si HD© system.

Conditions

• Keratitis
• Pterygium
• Corneal Opacity Corneal Thinning
• Corneal Perforation

Interventions

Type	Name	Description
DEVICE	1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
DEVICE	Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)
DEVICE	Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2014-04-16
• Last updated: 2019-08-21

Locations

1 site across 1 country: France