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Robotic Surgery of the Ocular Surface

NCT02116062 · University Hospital, Strasbourg, France · Updated 21 Aug 2019

What is being tested
1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique); Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique); Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
For
Keratitis; Pterygium; Corneal Opacity Corneal Thinning; Corneal Perforation
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 12 people. The full rules are on the registry page.
Where
France
When
Starts or started June 2014, ends April 2018. Registered 16 April 2014.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT02116062

Sites

  • Hôpitaux Universitaires de StrasbourgStrasbourg, France