Robotic Surgery of the Ocular Surface
Primary Purpose
Keratitis, Pterygium, Corneal Opacity Corneal Thinning
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)
Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
Sponsored by
About this trial
This is an interventional treatment trial for Keratitis
Eligibility 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
Sites / Locations
- Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Amniotic membrane transplantation
Pterygium surgery
Penetrating keratoplasty
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02116062
First Posted
February 24, 2014
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02116062
Brief Title
Robotic Surgery of the Ocular Surface
Official Title
Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The results concerning amniotic membrane transplantation (n=7) and robot-assisted pterygium surgery (n=5) were conclusive
Study Start Date
June 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Pterygium, Corneal Opacity Corneal Thinning, Corneal Perforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amniotic membrane transplantation
Arm Type
Other
Arm Title
Pterygium surgery
Arm Type
Other
Arm Title
Penetrating keratoplasty
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
Intervention Type
Device
Intervention Name(s)
Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)
Intervention Type
Device
Intervention Name(s)
Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
Primary Outcome Measure Information:
Title
Respect for different phases of the operating procedure of each intervention.
Description
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)
Time Frame
At the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bourcier Tristan, PHMD
Organizational Affiliation
Les Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26203760
Citation
Bourcier T, Chammas J, Becmeur PH, Danan J, Sauer A, Gaucher D, Liverneaux P, Mutter D. Robotically Assisted Pterygium Surgery: First Human Case. Cornea. 2015 Oct;34(10):1329-30. doi: 10.1097/ICO.0000000000000561.
Results Reference
derived
Learn more about this trial
Robotic Surgery of the Ocular Surface
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