Neurotrophic KeratitisMICORNENCT03037450
Miniinvasive Corneal Neurotization. A Pilot Study.
A study testing Miniinvasive corneal neurotization in people with Neurotrophic Keratitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- Miniinvasive corneal neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 22 Jan 2019
- 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
- Patient older than 18.
- NK stages 2 and 3 (Mackie's classification).
- Non-response to maximal medical treatment (lachrymal substitution, autologous serum).
- Postherpetic or post-zoster NK (Group 1).
- Postoperative NK (neurosurgery and trigeminal thermocoagulation) (Group 2).
- Posttraumatic NK (orbital trauma, ocular burn) (Group 3).
Show all 10Show fewer
- No ocular hypertony in both eyes.
- Visual acuity > 20/40 on the contralateral eye.
- Written consent of the patient.
- Patient benefiting from national health coverage (either as a direct user or beneficiary).
Who cannot join
- Impossibility of general anesthesia.
- Herpetic or zoster recurrence in the 6 months prior surgery.
- Length of NK evolution > 5 years.
- Congenital NK.
- Bilateral NK.
- Other causes of NK: diabeta mellitus, amylosis, sarcoidosis, multiple sclerosis, vitamin A or B12 deficiency, Sjögren syndrome, GVH disease, topical NSAID, topical beta-blockers, history of refractive surgery.
Show all 11Show fewer
- Mental illness.
- Adult with legal guardian or guardianship.
- Pregnancy.
- Breast-feeding.
- Patient's unable to understand informations.
Trial locations and contacts
1 site in 1 country.
About this study
Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or infection. An important and permanent visual loss of is frequently associated with the condition. NK can be congenital or acquired. Its acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction techniques of sensory neurotizations have recently been described in young patients suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve segment into a tissue to reestablish either motor or sensory innervation. The aim of the present study is to assess the outcomes of a novel sensory neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious, traumatic or iatrogenic causes will be included.
- Conditions
- Neurotrophic Keratitis
- Being tested
- Miniinvasive corneal neurotization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniinvasive corneal neurotizationProcedure or surgery
Neurotization of a neurotrophic cornea
| Study group | Role | What they receive |
|---|---|---|
| Miniinvasive corneal neurotization | Other | Not described Receives: Procedure: Miniinvasive corneal neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal sensation scores.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Why it stopped: The reasons for stopping the research are : * Inclusion difficulties (demanding inclusion and exclusion criteria), * The Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037450
- Sponsor's protocol ID
- 6528
- Acronym
- MICORNE
- Status last verified
- Sep 2021
- First submitted
- 17 Jan 2017
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miniinvasive Corneal Neurotization. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03037450
- Acronym / sponsor ID
- MICORNE / 6528
- Conditions
- Neurotrophic Keratitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reasons for stopping the research are : * Inclusion difficulties (demanding inclusion and exclusion criteria), * The Covid-19 pandemic
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 31 Jan 2017 (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.
Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or infection. An important and permanent visual loss of is frequently associated with the condition. NK can be congenital or acquired. Its acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction techniques of sensory neurotizations have recently been described in young patients suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve segment into a tissue to reestablish either motor or sensory innervation. The aim of the present study is to assess the outcomes of a novel sensory neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious, traumatic or iatrogenic causes will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miniinvasive corneal neurotization | Other | Procedure: Miniinvasive corneal neurotization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient older than 18.
- NK stages 2 and 3 (Mackie's classification).
- Non-response to maximal medical treatment (lachrymal substitution, autologous serum).
- Postherpetic or post-zoster NK (Group 1).
- Postoperative NK (neurosurgery and trigeminal thermocoagulation) (Group 2).
Key exclusion criteria (11 listed)
- Impossibility of general anesthesia.
- Herpetic or zoster recurrence in the 6 months prior surgery.
- Length of NK evolution > 5 years.
- Congenital NK.
- Bilateral NK.
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 |
|---|---|---|
| Miniinvasive corneal neurotizationNeurotization of a neurotrophic cornea | Procedure or surgery | Miniinvasive corneal neurotization |
Primary outcome
Corneal sensation scores.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The reasons for stopping the research are : * Inclusion difficulties (demanding inclusion and exclusion criteria), * The Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Neurotrophic Keratitis
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 2
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Neurotrophic Keratitis
RecruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Ocular Surface Disease, Neurotrophic Keratopathy Stage 1
RecruitingObservational study
The Prevalence of Hypoesthesia Related Keratitis in Ocular Graft Vs. Host Disease (GVHD) Patients
Ocular GVHD
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miniinvasive corneal neurotization in people with Neurotrophic Keratitis, 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 10 inclusion and 11 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 20 Sep 2021. 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 reasons for stopping the research are : * Inclusion difficulties (demanding inclusion and exclusion criteria), * The Covid-19 pandemic). 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?
Corneal sensation scores. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2021.