Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device (AmnioClip) in the Therapy of Ocular Surface Disorders (Sutureless Amniotic Membrane Transplantation)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Slit lamp investigation of the inflammation status of the conjunctiva
研究概览
简要总结
The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.
详细描述
A ring system (AmnioClip) was developed for mounting an amniotic membrane (AM) that can be applied like a large contact lens. AM is mounted between the two rings with a special designed, accessory mounting device. The safety of the ring system AmnioClip was tested in an interventional including 7 patients with ocular surface disorders and need for AM transplantation (1, 2, 3). About similar systems was reported (3, 4).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ocular surface disorders and indication for amniotic membrane transplantation
- •Willingness to provide signed Informed Consent Form
- •For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
- •Ability and willingness to return for all scheduled visits and assessments
排除标准
- •An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation
研究组 & 干预措施
Amniotic membrane ring
Application of amniotic membrane device for 6-7 days.
干预措施: Amniotic membrane ring (Device)
结局指标
主要结局
Slit lamp investigation of the inflammation status of the conjunctiva
时间窗: Participants will be followed for the duration of hospital stay, an expanded average of 3 month
The ring of the AmnioClip touches the conjunctiva of the ocular surface. To prove side effects through the medical device the conjunctiva is controlled at every visit with microscopy using a slit lamp.
次要结局
未报告次要终点
研究者
Katrin Engelmann
Principal Investigator
Klinikum Chemnitz gGmbH