Robotic Surgery of the Ocular Surface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-04-30

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.

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Detailed Description

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Conditions

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Keratitis Pterygium Corneal Opacity Corneal Thinning Corneal Perforation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amniotic membrane transplantation

Group Type OTHER

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

Intervention Type DEVICE

Pterygium surgery

Group Type OTHER

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

Intervention Type DEVICE

Penetrating keratoplasty

Group Type OTHER

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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