NCT03037450: MICORNE

Miniinvasive Corneal Neurotization. A Pilot Study.

Terminated NA Last updated 20 September 2021

What this trial tests

NA trial testing Miniinvasive corneal neurotization in Neurotrophic Keratitis in 1 participant. Terminated before completion.

Timeline

1 June 2017

Primary endpoint
22 January 2019

22 January 2019

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	1 June 2017
Primary completion	22 January 2019
Estimated completion	22 January 2019
Sites	1 location across France

Drugs / interventions tested

• Miniinvasive corneal neurotization

Conditions studied

• Neurotrophic Keratitis — all drugs for Neurotrophic Keratitis →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Neurotrophic Keratitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neurotrophic keratitis: current challenges and future prospects.
   Versura P, Giannaccare G, Pellegrini M, Sebastiani S, et al · · 2018 · cited 119× · PMID 29988739 · DOI 10.2147/eb.s117261