Autologous Platelet-rich Plasma in the Treatment of Persistent Corneal Epithelial Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Persistent epithelial defect healing time.
研究概览
简要总结
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.
详细描述
Persistent epithelial defects (PED) are corneal lesions that do not heal within the first two weeks of conventional treatment (i.e. preservative-free lubricant, bandage contact lens (BCL), ocular lubricant ointment, eye patching). These defects are the result of the loss of certain lacrimal factors that maintain the integrity and homeostasis of the corneal epithelium and ocular surface. Normally, PED heal rapidly in the healthy eye. However, underlying ocular surface pathology can slow down the healing process and contribute to the persistence of the epithelial defect. Hematopoietic derivatives such as autologous platelet-rich plasma (PRP) may replace these missing components and eventually lead to complete healing in a faster and more comfortable way for the patient. The objective of this study is to determine if PRP combined with BCL is more effective than preservative-free lubricant combined with BCL 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 treatment will be administered until achieving complete defect closure. The effectiveness of each treatment will be measured in terms of days taken to achieve complete closure. Since PED is a complex disease that is difficult to treat, the available treatments are not very effective, therefore, PED might progress even to perforation regardless of the treatment. In this last scenario, we will provide appropriate treatment for progressive corneal thinning and corneal perforation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not blinded study.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Patients diagnosed with:
- •Peripheral ulcerative keratitis, or Mooren's ulcer.
- •Active infectious keratitis and/or ulcers.
研究组 & 干预措施
PRP plus BCL
Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
干预措施: PRP plus BCL (Combination Product)
BCL plus PFL
Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
干预措施: BCL plus PFL (Combination Product)
Eye patch plus ocular lubricant ointment
Eye patch plus ocular lubricant ointment every 24 hours.
干预措施: Eye patch plus ocular lubricant ointment (Combination Product)
结局指标
主要结局
Persistent epithelial defect healing time.
时间窗: From the first day of treatment until the date of complete defect closure, assessed up to 3 months.
Persistent epithelial defect healing time measured in days.
次要结局
- 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.)
- Change in corneal sensitivity(Change from baseline corneal sensitivity at the date of defect closure, up to 3 months.)
- Frequency of adverse events, recurrences and/or treatment failure(These will be evaluated from the beginning of the treatment until three months after defect closure.)
- 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(At date of randomization and at date of defect closure, up to 3 months.)
- Quality of life questionnaire(At date of randomization and at date of defect closure, up to 3 months.)
研究者
Karim Mohamed-Noriega
Professor
Universidad Autonoma de Nuevo Leon