An interventional study of 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique) and Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique) in Keratitis, Pterygium and Corneal Opacity Corneal Thinning, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment
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.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 70 interventional studies indexed under Keratitis.
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symptomatic pterygium
Exclusion Criteria:
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
Respect for different phases of the operating procedure of each intervention.
Surgeons will check that all steps of the surgery have been done and successfully completed (thanks to a surgery ckeck-list procedure and video tape)
Time frame: At the end of the surgery
Ran from Jun 2014 to primary completion in Apr 2018, 46 months.
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →