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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.
Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
Bilbao, Bizkaia, Spain
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, Spain
Instituto de Microcirugía Ocular (IMO)
Barcelona, Spain
Hospital Ramón y Cajal
Madrid, Spain
Percentage of patients with a reduction of corneal defect of >50%
Time frame: 4 weeks
Percentage of patients with a reduction of corneal defect of >50%
Time frame: 2 weeks
Percentage of patients showing complete healing of the corneal defect
Time frame: 4 weeks
Percentage of patients showing complete healing of the corneal defect
Time frame: 2 weeks
Measurement of the depth of the corneal defect (mm)
Time frame: 2 and 4 weeks
Changes in percentage in Best corrected visual acuity (BCVA LogMAR)
Time frame: 2 and 4 weeks
Ocular pain with VAS scale
Time frame: 2 and 4 weeks
Osmolarity of lacrimal film
Time frame: 2 and 4 weeks
Measurement of treatment tolerance
Measurement of treatment tolerance with a 0 4 score
Time frame: 2 and 4 weeks
Adverse events
Percentage of adverse event occurrence
Time frame: 2 and 4 weeks
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