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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhNGF group | Therapeutic contact lens use was discontinued during the duration of the study. Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment. Changes in the corneal epithelium and stroma were evaluated by slit lamp biomicroscopy and photo documentation of the cornea after fluorescein staining. |
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| control comparator group | control comparator group was matched for age and gender and underwent assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops | Drug | rhNGF 20µg/ml (Cenegermin) eyedrops, 1 drop every 2 hours (6 times a day) for 8 weeks. Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of sub-basal nerve density, diameter and number of nerve branches | evaluated by In Vivo Confocal Microscopy (IVCM). Confocal microscopic scanning was focused on central cornea and superior, inferior, nasal and temporal quadrants; for each zone, 5 frames at the level of the epithelium and basal lamina were obtained. Corneal sub-basal nerve morphology and density was traced using NeuronJ, plug-in of ImageJ. Nerve regeneration rate was calculated. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Sensitivity | measured by the Cochet-Bonnet aesthesiometer at 4 and 8 weeks after start of the treatment. Corneal sensitivity is measured in each patient in cm. the filament was applied on the area of corneal defect and on superior, inferior, nasal and temporal quadrants. | 8 weeks |
| Changes of persistent epithelial defect and corneal ulcers |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo Mastropasqua, Professor | Ophtalmology Clinic, G. d'Annunzio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophtalmology Clinic, G.d'Annunzio University | Chieti | 66013 | Italy |
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determined by corneal fluorescein staining at 4, 8 weeks as defined by the central reading center on clinical pictures |
| 8 weeks |
| ID | Term |
|---|---|
| C000647429 | cenegermin |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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