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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad Autonoma de Nuevo Leon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Peripheral ulcerative keratitis, or Mooren's ulcer.

Active infectious keratitis and/or ulcers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PRP plus BCL

    Combination product

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

  • BCL plus PFL

    Combination product

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

  • Eye patch plus ocular lubricant ointment

    Combination product

    Eye patch plus ocular lubricant ointment every 24 hours.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: PRP plus BCLExperimental treatment 1 intervention
Group B: BCL plus PFLActive comparator 1 intervention
Group C: Eye patch plus ocular lubricant ointmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Persistent epithelial defect healing time.

Persistent epithelial defect healing time measured in days.

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

Secondary outcomes

1

Change in corneal sensitivity

Corneal sensitivity will be assessed with corneal esthesiometer Cochet-Bonnet.

Time frame
Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.
2

Uncorrected visual acuity

Uncorrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.

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

Best corrected visual acuity

Best corrected visual acuity will be assessed using Snellen cards. Measurements will be converted to LogMar values for statistical analysis.

Time frame
Every week (or sooner, if needed) from date of randomization until the date of complete defect closure, up to 3 months.
4

Ocular pain

Ocular pain will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (maximum pain), and includes 6 faces (visual representation), numbers, and written descriptions that represent the level of pain. The first face represents a pain score of 0 and it reads "no hurt"; the second face represents a pain score of 2 and it reads "hurts little bit"; the third face represents a pain score of 4 and it reads "hurts little more"; the fourth face represents a pain score of 6 and it reads "hurts even more"; the fifth face represents a pain score of 8 and it reads "hurts whole lot"; the last face represents a pain score of 10 and it reads "hurst worst". Lower values represent a better outcome.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Autonoma de Nuevo Leon

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Collaborator