Using platelet-rich plasma to treat neurotrophic keratopathy
Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy
This study is testing whether using a special treatment made from your own blood can help people with neurotrophic keratopathy heal their corneas better than just using artificial tears alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Autonoma de Nuevo Leon Academic / other |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT04604834 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of autologous platelet-rich plasma (APRP) in treating neurotrophic keratopathy, a condition that impairs corneal sensitivity and healing. Participants will be randomly assigned to receive either APRP combined with preservative-free artificial tears (PFAT), APRP alone, or PFAT alone in a crossover design over a total of 12 weeks. The goal is to determine which treatment combination leads to better healing outcomes for the cornea. A thorough ophthalmologic evaluation will be conducted before and during the treatment periods to monitor progress and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with neurotrophic keratopathy who have corneal erosions and meet specific inclusion criteria related to their medical history.
Not a fit: Patients with other ocular surface pathologies that cause corneal erosions but do not involve corneal hyposensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing and comfort for patients suffering from neurotrophic keratopathy.
How similar studies have performed: While the use of platelet-rich plasma in ocular conditions is gaining interest, this specific approach for neurotrophic keratopathy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with: * Neurotrophic keratopathy diagnosed by esthesiometry (defined as central corneal sensitivity ≤ 3cm using Cochet-Bonnet aesthesiometer). * Corneal erosions. * Neurotrophic keratopathy secondary to: diabetes mellitus, herpetic keratitis, microbial keratitis sequelae (bacteria, Acanthamoeba, fungi, herpes), limbal stem cell deficiency, chemical or thermic burn sequelae at least 3 months after the accident, ocular trauma with penetrating wound fixed at least 3 months before the trial, surgery carried out at least 3 month before the trial (including keratoplasty, laser in situ keratomileusis, phacoemulsification cataract surgery, extracapsular cataract extraction), adenoviral keratoconjunctivitis resolved at least 3 months the trial. Exclusion Criteria: * Patients diagnosed with: * Other ocular surface pathology presenting with corneal erosions but without corneal hyposensitivity. * Corneal epithelial defect with or without corneal hyposensitivity. * Pregnant women, homeless, migrants.
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,drkmohamed1@gmail.com
- 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.