Clinical trial NCT04293549: An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops
Official title: In Vivo Evaluation of Corneal Nerves and Epithelial Healing After Treatment With Nerve Growth Factor for Neurotrophic Keratopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurotrophic Keratopathy
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 patients (9 males and 9 females) were recruited from the Ocular Surface Service of G. d'Annunzio University of Chieti- Pescara and from the Division of Clinical Neuroscience, Department of Ophthalmology, University of Nottingham.

Brief summary: A prospective, longitudinal, cross-sectional, observational Study with a 8-week Follow-up to evaluate the renewal of corneal nerves structure and function in patients with Neurotrophic Keratopathy treated with recombinant human Nerve Growth Factor (rhNGF) eyedrops.

Detailed description: This Study shows that topical treatment with Recombinant Nerve Growth Factor (rhNGF) improved corneal sensitivity and increased sub-basal nerves density, promoting corneal healing of persistent epithelial defects and corneal ulcers in patients with stage 2 and 3 NK

Eligibility criteria: Inclusion Criteria:

* Patients with documented moderate or severe neurotrophic keratopathy based on a recent new classification of NK, refractory to conventional non surgical treatments. The diagnosis was made on medical and ophthalmological history, slit lamp examination, aesthesiometry, in vivo confocal microscopy.
* Decreased corneal sensitivity on the area of corneal defect and on superior, inferior, nasal and temporal quadrants (≤ 4 cm using the Cochet-Bonnet aesthesiometer)
* Patients who satisfy all Informed Consent requirements. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed
* Patients with ability to understand and perform the treatment.

Exclusion Criteria:

* active infective keratitis or inflammation not related to NK in the affected eye.
* presence of corneal dystrophies.
* presence of glaucoma.
* Any other ocular disease requiring topical ocular treatment during the course of the study treatment period.
* History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrolment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the stage 2 or 3 NK).
* patients with known hypersensitivity to one of the components of the study or procedural medications (e.g. anaesthetic drops, fluorescein).
* Females currently pregnant

Primary outcomes:
measure: Changes of sub-basal nerve density, diameter and number of nerve branches
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Corneal Sensitivity
timeFrame: 8 weeks
measure: Changes of persistent epithelial defect and corneal ulcers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ophtalmology Clinic, G.d'Annunzio University
Study officials:
affiliation: Ophtalmology Clinic, G. d'Annunzio University
name: Leonardo Mastropasqua, Professor
role: PRINCIPAL_INVESTIGATOR
References: