Robotic Surgery of the Ocular Surface
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Amniotic membrane transplantation
|
Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
|
Other: Pterygium surgery
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Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)
|
Other: Penetrating keratoplasty
|
Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
|
Outcome Measures
Primary Outcome Measures
- Respect for different phases of the operating procedure of each intervention. [At the end of the surgery]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patient > 18 year-old suffering :
symptomatic pterygium
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chronic corneal ulceration resistant to medical treatment
-
corneal opacity involving corneal stroma and corneal endothelium
-
corneal thinning
-
corneal perforation
Exclusion Criteria:
-
History of eye surgery
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psychiatric disease
-
mental deficiency
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pregnancy
-
nursing mother
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hôpitaux Universitaires de Strasbourg | Strasbourg | France | 67091 |
Sponsors and Collaborators
- University Hospital, Strasbourg, France
Investigators
- Principal Investigator: Bourcier Tristan, PHMD, Les Hôpitaux Universitaires de Strasbourg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5540