Robotic Surgery of the Ocular Surface

Study Overview
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Brief Summary
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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.

Official Title
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Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

Conditions
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Keratitis, Pterygium, Corneal Opacity Corneal Thinning, Corneal Perforation

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient > 18 year-old suffering : symptomatic pterygium 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 psychiatric disease mental deficiency pregnancy nursing mother

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amniotic membrane transplantation<br> | Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)<br> <br> |
| Other: Pterygium surgery<br> | Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)<br> <br> |
| Other: Penetrating keratoplasty<br> | Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At the end of the surgery |