Robotic Surgery of the Ocular Surface

August 19, 2019 updated by: University Hospital, Strasbourg, France

Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respect for different phases of the operating procedure of each intervention.
Time Frame: 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)
At the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Bourcier Tristan, PHMD, Les Hôpitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5540

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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