Miniinvasive Corneal Neurotization. A Pilot Study.

Neurotrophic Keratitis Clinical Trial

— MICORNE  

Official title:

Miniinvasive Corneal Neurotization. A Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03037450
• Other study ID #: 6528
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: January 22, 2019

Study information

• Verified date: September 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Keratitis
• Neurotrophic Keratitis

Intervention

Procedure:
• Miniinvasive corneal neurotization
Neurotization of a neurotrophic cornea

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal sensation scores.		12 months