KeratitisNCT02116062
Robotic Surgery of the Ocular Surface
A study testing 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) and Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot in people with Keratitis and Pterygium, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratitis, Pterygium, Corneal Opacity Corneal Thinning
- What is being tested?
- 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) and Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of eye surgery
- psychiatric disease
- mental deficiency
- pregnancy
- nursing mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- 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
- Medical subject headings
- Keratitis, Pterygium, Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)Device
Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)Device
Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robotDevice
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane transplantation | Other | Not described Receives: Device: 1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique) |
| Pterygium surgery | Other | Not described Receives: Device: Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique) |
| Penetrating keratoplasty | Other | Not described Receives: Device: Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: The results concerning amniotic membrane transplantation (n=7) and robot-assisted pterygium surgery (n=5) were conclusive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bourcier Tristan, PHMD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116062
- Sponsor's protocol ID
- 5540
- Status last verified
- Aug 2019
- First submitted
- 24 Feb 2014
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26203760
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Microsurgery of the Ocular surfaceProspective Human Feasibility Study
- ClinicalTrials.gov ID
- NCT02116062
- Acronym / sponsor ID
- 5540
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results concerning amniotic membrane transplantation (n=7) and robot-assisted pterygium surgery (n=5) were conclusive
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- History of eye surgery
- psychiatric disease
- mental deficiency
- pregnancy
- nursing mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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© robot | Device | Penetrating keratoplasty |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: The results concerning amniotic membrane transplantation (n=7) and robot-assisted pterygium surgery (n=5) were conclusive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 26203760Bourcier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bourcier Tristan, PHMD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) and Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot in people with Keratitis and Pterygium, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The results concerning amniotic membrane transplantation (n=7) and robot-assisted pterygium surgery (n=5) were conclusive). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respect for different phases of the operating procedure of each intervention. (time frame: At the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.