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

OF18-00003

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.

2018-08-30

2025-08-01

2025-08-01

Recruiting

54

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not blinded study.'}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

2024-05-08