Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04604834

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

Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-06

39

Participants Needed

1

Research Sites

369 weeks

Total Duration

On this page

Sponsors

U

Universidad Autonoma de Nuevo Leon

Lead Sponsor

H

Hospital Universitario Dr. Jose E. Gonzalez

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed neurotrophic keratopathy confirmed by corneal sensitivity of 3 cm or less using Cochet-Bonnet aesthesiometer
  • Presence of corneal erosions
  • Neurotrophic keratopathy caused by diabetes mellitus, herpetic keratitis, microbial keratitis sequelae, limbal stem cell deficiency, chemical or thermal burn sequelae at least 3 months after injury, ocular trauma with penetrating wound fixed at least 3 months prior, surgery at least 3 months prior (including keratoplasty, LASIK, cataract surgeries), or adenoviral keratoconjunctivitis resolved at least 3 months prior
Not Eligible

You will not qualify if you...

  • Other eye surface diseases with corneal erosions but without reduced corneal sensitivity
  • Corneal epithelial defect with or without reduced corneal sensitivity
  • Pregnant women
  • Homeless individuals
  • Migrants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

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Research Team

K

Karim Mohamed-Noriega, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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