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临床试验/NCT04608084
NCT04608084Unknown4 期

Platelet Rich Plasma Eye Drops for Treatment of Ocular Surface Disease

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
4 期
入组人数
100
试验地点
2
主要终点
Mean change from baseline in Ocular Surface Disease Index (OSDI) score questionnaire

研究概览

简要总结

The purpose of this study is to evaluate prospectively the efficacy of topical administration of autologous platelet rich plasma as monotherapy for the treatment of symptoms and clinical signs in cases affected by moderate to severe forms of ocular surface disease

详细描述

Background Ocular Surface Disease (OSD) is a multifactorial disease of the ocular surface and tears that produce symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. The prevalence of Ocular surface disease reported in the literature up to 30% of the elderly population. There are two main mechanisms that explain this ocular surface dysfunction: aqueous deficiency and excessive evaporation of the tear film. The aqueous deficient dry eye disease is characterized by an insufficient volume of tears due to dysfunction of the lacrimal glands and obstruction of the lacrimal ducts. This mechanism is also related to autoimmune diseases such as Sjogren's syndrome, Lupus, and Rheumatoid arthritis. Meibomian gland dysfunction, eyelid problems (infrequent blinking, entropion, ectropion) are typical causes of evaporative dry eye. Poor tear film quality is the result of tear hyperosmolarity and goblet cell mucin deficiency. Ocular surface disease can also arise as iatrogenic complication after external or internal ocular surgery, laser treatment, radiation, chemotherapy or ocular medications.

Treating ocular surface diseases can be challenging and treatment usually depends on the underlining etiology and can be divided into medical treatment and surgical solutions. Non preserved artificial tears are usually the first line treatment for OSD associated with aqueous deficiency and anti-inflammatory drops like steroids, lifitegrast 5% (Xiidra-shire) and cyclosporin 0.05% (Restasis - allergan) often accompanied for treating the underling inflammatory process, However, none of these treatment includes essential tear components such as growth factors, vitamins, and immunoglobulins.

Hemoderivatives drops such as autologous serum (AS) have been recommended for the treatment of several ocular surface disturbances, such as Sjögren's syndrome-related tear deficiency, non-Sjögren's tear deficiency associated with graft-versus-host disease, neurotrophic keratitis, persistent epithelial defects, superior limbic keratoconjunctivitis, as well as a supportive measure in ocular surface reconstruction.

Platelet rich plasma (PRP) has been reported as successful treatments for moderate to severe OSD caused by dry eye, presenting advantages over AS due to its richer concentration of growth factors, anti-inflammatory cytokines, and other platelet derivatives. The high concentration of platelets obtained through a relatively simple process, which requires minimal manipulation and no addition of any other substance.

studies have shown that these components help in the proliferation, migration, and differentiation of corneal epithelial cells, which is beneficial for the required ocular surface restoration in moderate to severe forms of OSD

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Potential participants diagnosed with moderate to sever ocular surface disease. Participant will be included when the fluorescein corne-conjunctival staining score is 5 or more as determined by NEI/Industry Grading System and OSDI questionnaire score of 20 or more, after treatment with non-preserved artificial tears 4/day for at least 1 month.

排除标准

  • Under the age of 18 years or incapacitated patients.

结局指标

主要结局

Mean change from baseline in Ocular Surface Disease Index (OSDI) score questionnaire

时间窗: At 6 and 12 weeks visit

The OSDI assesses quality of life measures of ocular surface disease symptoms which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported outcomes in order to support medicinal product submissions and clinical drug trial efficacy

次要结局

  • Mean change from baseline of Corneo-conjunctival staining score(At 6 and 12 weeks visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allan Slomovic

M.D

University Health Network, Toronto

研究点 (2)

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