Miniinvasive Corneal Neurotization. A Pilot Study. (MICORNE)
Primary Purpose
Neurotrophic Keratitis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Miniinvasive corneal neurotization
Sponsored by
About this trial
This is an interventional treatment trial for Neurotrophic Keratitis
Eligibility Criteria
Inclusion Criteria:
- 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).
- 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).
Exclusion Criteria:
- 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.
- Mental illness.
- Adult with legal guardian or guardianship.
- Pregnancy.
- Breast-feeding.
- Patient's unable to understand informations.
Sites / Locations
- Les Hôpitaux Universitaires
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Miniinvasive corneal neurotization
Arm Description
Outcomes
Primary Outcome Measures
Corneal sensation scores.
Secondary Outcome Measures
Full Information
NCT ID
NCT03037450
First Posted
January 17, 2017
Last Updated
September 13, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT03037450
Brief Title
Miniinvasive Corneal Neurotization. A Pilot Study.
Acronym
MICORNE
Official Title
Miniinvasive Corneal Neurotization. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
The reasons for stopping the research are :
Inclusion difficulties (demanding inclusion and exclusion criteria),
The Covid-19 pandemic
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotrophic Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miniinvasive corneal neurotization
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Miniinvasive corneal neurotization
Intervention Description
Neurotization of a neurotrophic cornea
Primary Outcome Measure Information:
Title
Corneal sensation scores.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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).
Exclusion Criteria:
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.
Mental illness.
Adult with legal guardian or guardianship.
Pregnancy.
Breast-feeding.
Patient's unable to understand informations.
Facility Information:
Facility Name
Les Hôpitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Miniinvasive Corneal Neurotization. A Pilot Study.
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