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临床试验/NCT07066865
NCT07066865已完成不适用

Safety and Efficacy of Sutureless Dehydrated Amniotic Membrane (Omnigen) Mounted on Contact Lens (Omnilenz) for Ttt of Ocular Graft vs Host Disease

Farwaniya Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2022年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops

研究概览

简要总结

A case series of patients presented with graft versus host disease with ocular involvement . The study recruited a total of 3 patients who were referred to cornea clinic of Farwaniya Hospital, Kuwait between April 2022 and April 2024. All cases presented with severe dryness, spks and corneal epithelial defect not responding to other measures of treatment. An OmniLenz was applied for each patient for one week. Primary outcome measures included healing of the corneal resistant epithelial defect, secondary outcome measures were improvement of signs of dryness.

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

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Ocular graft versus host disease

排除标准

  • Patient with conjunctival fibrosis and symblephara formation (which interfere with application of the omnilenz)

结局指标

主要结局

Epithelial healing, Slit lamp examination with cobalt blue light after installation of fluorescein eye drops

时间窗: 1 week ( duration of the application of omnilenz )

次要结局

  • Omnigen tolerability, Questionnaire for the patients asking about discomfort sensation or the need to patch the eye(1 week ( duration of the application of omnilenz ))

研究者

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

Nancy Lotfy, MD

MD

Farwaniya Hospital

研究点 (1)

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