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The study was suspended due to recruitment difficulties
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Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the regeneration deterioration and development of corneal ulceration, their fusion, and perforation The main characteristic in the NK is a decrease or absence of corneal sensitivity.
The goals of treatment in the neurotrophic keratitis are prevent the progression of corneal damage, maintain eye structure and improve the transparency of the cornea. Therapy should be initiated early and based on the clinical stage of the disease because it depends on epithelial state and in the degree of corneal hypoesthesia.
Plasma rich in growth factors (PRGF-Endoret) represent a new technology using autologous proteins, growth factors and biomaterials as therapeutic formulations for different regenerative purposes. Under strict pharmaceutical development, it is possible to develop biologically stable eye drops, which have been shown to be useful for treating diverse ocular surface diseases. PRGF-Endoret eye drops could be an alternative therapy for patients with NK, and thus the objective of this clinical trial is to demonstrate its possible efficacy and its safety in patients with NK in stages 2 and 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRGF-Endoret eye-drops | Experimental |
| |
| Artificial tears eye-drops | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRGF-Endoret | Drug | Active treatment will be PRP eye drops obtained by the PRGF-Endoret system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a reduction of corneal defect of >50% | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a reduction of corneal defect of >50% | 2 weeks | |
| Percentage of patients showing complete healing of the corneal defect | 4 weeks | |
| Percentage of patients showing complete healing of the corneal defect |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Clínico Quirúrgico de Oftalmología (ICQO) | Bilbao | Bizkaia | Spain | |||
| Instituto Oftalmológico Fernández-Vega |
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| Artificial tears eye-drops | Drug | Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives). |
|
| 2 weeks |
| Measurement of the depth of the corneal defect (mm) | 2 and 4 weeks |
| Changes in percentage in Best corrected visual acuity (BCVA LogMAR) | 2 and 4 weeks |
| Ocular pain with VAS scale | 2 and 4 weeks |
| Osmolarity of lacrimal film | 2 and 4 weeks |
| Measurement of treatment tolerance | Measurement of treatment tolerance with a 0 4 score | 2 and 4 weeks |
| Adverse events | Percentage of adverse event occurrence | 2 and 4 weeks |
| Oviedo |
| Principality of Asturias |
| Spain |
| Instituto de Microcirugía Ocular (IMO) | Barcelona | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |