NCT06831253招募中不适用
Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma (PRP) Into the Lacrimal Gland in Severe Dry Eye Syndromes (ReLIPSSO)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
研究概览
简要总结
The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.
详细描述
injections in lacrimal gland four times during the study for each patient
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
盲法说明
To assess the lacrimal secretion after 4 injections of PRP in lacrimal gland
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Platelet counts, and clotting factors in the standarts
- •Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist
排除标准
- •Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
- •Patients with complete stenosis of both lacrimal meatus in the treated eye
研究组 & 干预措施
Injection of Platelet-Rich Plasma (PRP)
Experimental
干预措施: injections of Platelet-Rich Plasma in lacrimal gland (Other)
结局指标
主要结局
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
时间窗: week 16
Schirmer I test score between 0mm and more 20mm
次要结局
- To compare the different clinical follow-up parameters of qualitative dry ocular syndrome and quantitative after 4 monthly injections of PRP into the lacrimal gland(week 16)
研究者
研究点 (1)
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