Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04604834 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Nov 2025 to Nov 2027
    • Study completion date: Dec 2025 to Dec 1, 2027
    v7
  2. Notable Primary completion date: Nov 2024 to Nov 2025
    • Study completion date: Dec 2024 to Dec 2025
    v6
  3. Notable Primary completion date: Nov 2022 to Nov 2024
    • Study completion date: Dec 2022 to Dec 2024
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Primary completion date: Apr 2022 to Nov 2022
    • Study completion date: May 2022 to Dec 2022
    • Start date changed from estimate of Apr 2021 to Nov 1, 2020
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Nov 2020 to Apr 2021
    • Primary completion date: Nov 2021 to Apr 2022
    • Study completion date: Dec 2021 to May 2022
    • Site details revised
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04604834
Lead Sponsor Universidad Autonoma de Nuevo Leon
Collaborators: Hospital Universitario Dr. Jose E. Gonzalez
Conditions
(from sponsor)
Neurotrophic Keratopathy
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov