Actively Recruiting

Phase Not Applicable
All Genders
ID03653650

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

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

54

Participants Needed

1

Research Sites

N/A

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

This research aims to compare different treatments for persistent epithelial defects (PED), which are corneal ulcers that do not heal within two weeks despite standard care. These ulcers result from missing substances in tears that normally help corneal healing, and the condition can worsen in diseases like diabetes. The study will evaluate whether autologous platelet-rich plasma (PRP) with a bandage contact lens heals PED faster than preservative-free lubricant with a bandage contact lens or eye patch with ocular lubricant ointment. Participants will be randomly assigned to one of three treatment groups: PRP eye drops with a bandage contact lens every 1 to 3 hours, preservative-free lubricant eye drops with a bandage contact lens every 1 to 3 hours, or an eye patch with ocular lubricant ointment applied every 24 hours. Treatments will continue until the corneal defect fully heals. If the ulcer worsens to corneal thinning or perforation, appropriate medical care will be provided. During the study, healing time will be closely monitored with assessments up to three months, including corneal sensitivity, visual acuity, ocular pain, surface symptoms, and quality of life. Researchers will also track adverse events, recurrences, and treatment failures. Weekly evaluations or sooner if needed will help measure progress, ensuring participant safety and thorough monitoring throughout the treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with persistent epithelial defect
  • Diagnosis of recurrent corneal epithelial defect or neurotrophic keratopathy
  • Neurotrophic keratopathy secondary to conditions such as diabetes mellitus, herpes simplex or zoster virus infection, microbial keratitis sequelae, multiple sclerosis, Parkinson's disease, cranial nerve palsy, chemical or thermal burn sequelae, trauma, surgery, chronic dry eye, or rheumatic disease
Not Eligible

You will not qualify if you...

  • Diagnosis of peripheral ulcerative keratitis or Mooren's ulcer
  • Presence of active infectious keratitis or corneal ulcers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 months or until complete defect closure

Participants receive one of three treatments: bandage contact lens plus autologous platelet-rich plasma eye drops every 1 to 3 hours, bandage contact lens plus preservative-free lubricant eye drops every 1 to 3 hours, or eye patch plus ocular lubricant ointment every 24 hours. Treatment continues until complete healing of the corneal epithelial defect.

Weekly visits or sooner if needed

Follow-up

Duration - Up to 3 months after defect closure

Participants are monitored for adverse events, recurrences, and treatment failure for up to three months after defect closure.

Visits as needed based on participant condition

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.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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Published Research Related To This Trial

Ciliary Neurotrophic Factor Promotes the Migration of Corneal Epithelial Stem/progenitor Cells by Up-regulation of MMPs through the Phosphorylation of Akt.

Jialin Chen, Peng Chen, Ludvig J Backman...

https://pubmed.ncbi.nlm.nih.gov/27174608