Robotic Surgery of the Ocular Surface

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Corneal Perforation; Corneal Opacity Corneal Thinning; Pterygium; Keratitis

Treatments: 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; Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)

Study type: Interventional

Funder types: Other

Identifiers

NCT02116062

5540

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Amniotic membrane transplantation

Other group

Treatment:

Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)

Pterygium surgery

Other group

Treatment:

Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)

Penetrating keratoplasty

Other group

Treatment:

Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot