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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 24, 2014
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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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
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Robotic Surgery of the Ocular Surface

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