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Robotic Surgery of the Ocular Surface

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02116062
First received: February 24, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose
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 Intervention
Keratitis
Pterygium
Corneal Opacity Corneal Thinning
Corneal Perforation
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Respect for different phases of the operating procedure of each intervention. [ Time Frame: At the end of the surgery ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 15
Study Start Date: June 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amniotic membrane transplantation Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
Pterygium surgery Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)
Penetrating keratoplasty Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116062

Locations
France
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02116062     History of Changes
Other Study ID Numbers: 5540 
Study First Received: February 24, 2014
Last Updated: July 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Keratitis
Pterygium
Corneal Opacity
Corneal Perforation
Corneal Diseases
Eye Diseases
Conjunctival Diseases
Corneal Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on December 02, 2016