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Robotic Surgery of the Ocular Surface

Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02116062
Enrollment
12
Registered
2014-04-16
Start date
2014-06-30
Completion date
2018-04-30
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Opacity Corneal Thinning, Corneal Perforation, Keratitis, Pterygium

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.

Interventions

DEVICEPenetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
DEVICE1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)
DEVICEPterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Respect for different phases of the operating procedure of each intervention.At the end of the surgerySurgeons will check that all steps of the surgery have been done and successfully completed (thanks to a surgery ckeck-list procedure and video tape)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026