Using platelet-rich plasma to treat persistent corneal ulcers
Autologous Platelet-rich Plasma in the Treatment of Persistent Corneal Epithelial Defects
This study is testing if using a special treatment made from your own blood can help heal stubborn corneal ulcers better than standard eye care methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Sex | All |
| Sponsor | Universidad Autonoma de Nuevo Leon Academic / other |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT03653650 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of autologous platelet-rich plasma (PRP) combined with a bandage contact lens (BCL) in treating persistent epithelial defects (PED) compared to preservative-free lubricant with BCL and an eye patch with ocular lubricant ointment. PED are corneal ulcers that fail to heal within two weeks of standard treatment, often due to underlying conditions like diabetes. The study will randomly assign participants to one of three treatment groups and measure the time taken to achieve complete closure of the defect. The goal is to determine if PRP can enhance healing by providing missing factors that support corneal health.
Who should consider this trial
Good fit: Ideal candidates include patients with persistent epithelial defects and underlying conditions such as diabetes or neurotrophic keratopathy.
Not a fit: Patients with active infectious keratitis or specific types of keratitis like peripheral ulcerative keratitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing times for patients with persistent corneal ulcers.
How similar studies have performed: While the use of PRP in ocular conditions is gaining interest, this specific approach for PED is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with persistent epithelial defect and at least one of the following diagnoses: * Recurrent corneal epithelial defect. * Neurotrophic corneal ulcer. * Neurotrophic keratopathy secondary to any disease (i.e. diabetes mellitus, infection with herpes simplex virus or herpes zoster virus, microbial keratitis sequelae, multiple sclerosis, Parkinson's disease, VII cranial nerve palsy, chemical or thermic burn sequelae, trauma, surgery, iatrogenic, chronic dry eye, rheumatic disease). Exclusion Criteria: * Patients diagnosed with: * Peripheral ulcerative keratitis, or Mooren's ulcer. * Active infectious keratitis and/or ulcers.
Where this trial is running
Monterrey, Nuevo León
- Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico (Recruiting)
Study contacts
- Principal investigator: Karim Mohamed-Noriega, M.D. — Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez
- Study coordinator: Karim Mohamed-Noriega, M.D.
- Email: karim.mohamednrg@uanl.edu.mx
- Phone: +52 8183469259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.