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Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Aug 2025 to Aug 2027
    • Study completion date: Aug 2025 to Aug 1, 2027
    v9
  2. Notable Primary and study completion dates: Aug 2024 to Aug 2025v8
  3. Notable Primary and study completion dates: Aug 2022 to Aug 2024v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Notable Primary and study completion dates: Aug 2021 to Aug 2022v5
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  1. Notable Primary and study completion dates: Aug 2020 to Aug 2021v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2020 to Aug 2020
    • Start date changed from estimate of Sep 2018 to Aug 30, 2018
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Persistent epithelial defects (PED) are corneal ulcers that do not heal within the first two weeks of treatment with artificial tears or ocular lubricant ointment. It is believed that this condition is the result of the loss of certain substances normally present in the tears that aid in the healing process of the cornea. When the eye is healthy, these ulcers typically heal rapidly. However, when there is an underlying disease such as diabetes, this healing process is altered and it takes longer for the ulcer to heal. Autologous platelet-rich plasma (PRP) is a substance that is obtained from the patient's own blood and it is believed this substance may replace those missing factors in the tears of patients with PED. The purpose of this investigation is to find out whether PRP combined with a bandage contact lens is better than preservative free lubricant combined with bandage contact lens or than eye patch with ocular lubricant ointment for the treatment of PED. Participants will be randomly assigned to one of the three groups and will get the treatment until the ulcer heals completely. We will count the days it takes for the PED to heal and based on that we will determine wich treatment is more effective (the treatment that takes the least days to heal will be considered the most effective). Since this disease is difficult to treat and doesn't have a gold standard treatment, usually the available treatments are not as good as we would like, therefore, the ulcer might progress even to perforation regardless of the treatment. In these cases, we will provide appropriate treatment for progressive corneal thinning and corneal perforation.
Trial Details
NCT Number NCT03653650
Lead Sponsor Universidad Autonoma de Nuevo Leon
Collaborators: Hospital Universitario Dr. Jose E. Gonzalez
Conditions
(from sponsor)
Persistent Epithelial Defect
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov