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RECRUITING
NCT04604834
NA

Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy

Sponsor: Universidad Autonoma de Nuevo Leon

View on ClinicalTrials.gov

Summary

Neurotrophic keratopathy (NK) is a condition where the cornea loses its capacity to feel pain and touch. This causes a decrease in the production of certain substances that maintain the integrity of the corneal epithelium (the most superficial layer that covers the cornea). As a result, the cornea cannot heal wounds as fast as it should and this could lead to corneal breakdown. This disease is chronic, meaning that it does not resolve quickly, and the treatments commonly used to manage it (such as artificial tears) take a long time to work, which makes it hard to follow doctor's orders. Autologous platelet-rich plasma is a substance that is obtained from the patient's own blood and it may contain those components that are missing in the tears of people with NK. The purpose of this experiment is to find out whether APRP+PFAT is better than APRP alone or PFAT alone in the treatment of NK. Participants will be randomly assigned to one of three groups: one group will start with APRP, other will start with PFAT and another with PFAT+APRP. The participants will receive each treatment for four weeks, and then the subjects will switch groups and use them for four weeks each (12 weeks total). Investigators will evaluate different parameters that will let us know if your condition is improving. These evaluations will be carried out every four weeks from the start to the end of the protocol. In case of intolerance or adverse effects, treatment will be discontinued.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2020-11-01

Completion Date

2025-12

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

OTHER

PFAT first

Week 1 to week 4: one eyedrop of PFAT (preservative-free artificial tears) every 2 hours. Week 5 to week 8: one eyedrop of APRP (autologous plasma rich platelet) every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.

OTHER

APRP first

Week 1 to week 4: one eyedrop of APRP every 2 hours. Week 5 to week 8: one eyedrop of PFAT every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.

Locations (1)

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico