NCT02116062

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

February 24, 2014

Last Update Submit

August 19, 2019

Conditions

KeratitisPterygiumCorneal Opacity Corneal ThinningCorneal Perforation

Outcome Measures

Primary Outcomes (1)

  • 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)

    At the end of the surgery

Study Arms (3)

Amniotic membrane transplantation

OTHER
Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)

Pterygium surgery

OTHER
Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)

Penetrating keratoplasty

OTHER
Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot

Interventions

1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)DEVICE
Amniotic membrane transplantation
Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)DEVICE
Pterygium surgery
Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robotDEVICE
Penetrating keratoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of eye surgery
  • psychiatric disease
  • mental deficiency
  • pregnancy
  • nursing mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

  • 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.

    PMID: 26203760DERIVED

MeSH Terms

Conditions

KeratitisPterygiumCorneal Perforation

Interventions

Inlays

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesConjunctival DiseasesCorneal InjuriesEye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Dental Restoration, PermanentDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Bourcier Tristan, PHMD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

April 16, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

FR(1)