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

NCT03653650 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Persistent Epithelial Defect

Interventions

COMBINATION_PRODUCT

PRP plus BCL

Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.

COMBINATION_PRODUCT

BCL plus PFL

Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.

COMBINATION_PRODUCT

Eye patch plus ocular lubricant ointment

Eye patch plus ocular lubricant ointment every 24 hours.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    collaborator OTHER

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Karim Mohamed-Noriega, M.D. · Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2027-08-31
Completion
2027-08-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653650 on ClinicalTrials.gov