Robotic Surgery of the Ocular Surface

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Terminated
CT.gov ID
NCT02116062
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
46
Actual Duration (Months)
0.3
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

ArmIntervention/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

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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Hôpitaux Universitaires de StrasbourgStrasbourgFrance67091

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.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02116062
Other Study ID Numbers:
  • 5540
First Posted:
Apr 16, 2014
Last Update Posted:
Aug 21, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2019