Miniinvasive Corneal Neurotization. A Pilot Study. (MICORNE)

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 Overview

• Status: Terminated
• Conditions: Neurotrophic Keratitis
• Intervention / Treatment: Procedure: Miniinvasive corneal neurotization

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • Les Hôpitaux Universitaires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Miniinvasive corneal neurotization	Procedure: Miniinvasive corneal neurotization; Neurotization of a neurotrophic cornea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal sensation scores.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: 6528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No