Neurotrophic Keratitis Clinical Trial
Official title:
Miniinvasive Corneal Neurotization. A Pilot 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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04485546 -
Study to Evaluate OXERVATEâ„¢ in Patients With Stage 1 Neurotrophic Keratitis
|
Phase 4 | |
Not yet recruiting |
NCT05927428 -
Assessment of the Safety and Efficacy of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis
|
Phase 2 | |
Completed |
NCT04552730 -
Nerve Growth Factor for the Treatment of Cornea Disease
|
||
Completed |
NCT04276558 -
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
|
Phase 2 | |
Recruiting |
NCT04573647 -
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
|
||
Completed |
NCT04820010 -
Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
|
||
Recruiting |
NCT04627571 -
Corneal Nerves After Treatment With Cenegermin
|
||
Enrolling by invitation |
NCT05758753 -
QST for Corneal Nerve Function
|
N/A | |
Terminated |
NCT05809245 -
Corneal Neurotization as a Treatment for Neurotrophic Keratopathy
|
N/A | |
Withdrawn |
NCT05321251 -
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06364657 -
Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
|
||
Recruiting |
NCT05566717 -
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
|
||
Not yet recruiting |
NCT02707120 -
Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis
|
Phase 4 | |
Completed |
NCT01756456 -
Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.
|
Phase 1/Phase 2 | |
Completed |
NCT02227147 -
Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
|
Phase 2 | |
Recruiting |
NCT05552261 -
DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
|
||
Recruiting |
NCT04909450 -
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06411145 -
Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
|
Phase 4 |