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

NCT03653650 | Recruiting

• 1 other identifier: OF18-00003
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platelet-Rich Plasma; Persistent Epithelial Defect

Outcome Measures

Primary Outcomes (1)

• Persistent epithelial defect healing time.

  Persistent epithelial defect healing time measured in days.

  From the first day of treatment until the date of complete defect closure, assessed up to 3 months.

Secondary Outcomes (8)

• Change in corneal sensitivity

  Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.

• Uncorrected visual acuity

  Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.

• Best corrected visual acuity

  Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.

• Ocular pain

  Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.

• Ocular surface symptoms

  Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.

Study Arms (3)

PRP plus BCL

EXPERIMENTAL

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

Combination Product: PRP plus BCL

BCL plus PFL

ACTIVE COMPARATOR

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

Combination Product: BCL plus PFL

Eye patch plus ocular lubricant ointment

ACTIVE COMPARATOR

Eye patch plus ocular lubricant ointment every 24 hours.

Combination Product: Eye patch plus ocular lubricant ointment

Interventions

PRP plus BCL COMBINATION_PRODUCT

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

PRP plus BCL

BCL plus PFL COMBINATION_PRODUCT

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

BCL plus PFL

Eye patch plus ocular lubricant ointment COMBINATION_PRODUCT

Eye patch plus ocular lubricant ointment every 24 hours.

Eye patch plus ocular lubricant ointment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients diagnosed with:
• Peripheral ulcerative keratitis, or Mooren's ulcer.
• Active infectious keratitis and/or ulcers.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator

Study Sites (1)

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (7)

• Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. Ophthalmology. 1999 Oct;106(10):1984-9. doi: 10.1016/S0161-6420(99)90412-8.

  PMID: 10519596 BACKGROUND

• Chen J, Chen P, Backman LJ, Zhou Q, Danielson P. Ciliary Neurotrophic Factor Promotes the Migration of Corneal Epithelial Stem/progenitor Cells by Up-regulation of MMPs through the Phosphorylation of Akt. Sci Rep. 2016 May 13;6:25870. doi: 10.1038/srep25870.

  PMID: 27174608 BACKGROUND

• Ljubimov AV, Saghizadeh M. Progress in corneal wound healing. Prog Retin Eye Res. 2015 Nov;49:17-45. doi: 10.1016/j.preteyeres.2015.07.002. Epub 2015 Jul 18.

  PMID: 26197361 BACKGROUND

• Nugent RB, Lee GA. Ophthalmic use of blood-derived products. Surv Ophthalmol. 2015 Sep-Oct;60(5):406-34. doi: 10.1016/j.survophthal.2015.03.003. Epub 2015 Apr 15.

  PMID: 26077627 BACKGROUND

• Alio JL, Rodriguez AE, WrobelDudzinska D. Eye platelet-rich plasma in the treatment of ocular surface disorders. Curr Opin Ophthalmol. 2015 Jul;26(4):325-32. doi: 10.1097/ICU.0000000000000169.

  PMID: 26058033 BACKGROUND

• Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.

  PMID: 17324465 BACKGROUND

• Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.

  PMID: 22972393 BACKGROUND

Study Officials

• Karim Mohamed-Noriega, M.D.

  Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim Mohamed-Noriega, M.D.

CONTACT

+52 8183469259; karim.mohamednrg@uanl.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not blinded study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomly assigned to three groups. Demographic characteristics and underlying etiologies will be identified. Subjects will undergo a general ophthalmologic evaluation (baseline) and PED size will be measured. Treatments will be administered until complete defect healing is achieved and visits will be scheduled weekly or as needed for continued ophthalmologic evaluation. After complete closure, subjects will be followed for three months with visits every 2 to 4 weeks to evaluate progress and identify recurrences.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 31, 2018
• Study Start: August 30, 2018
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)