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临床试验/NCT04306718
NCT04306718进行中(未招募)不适用

Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Proliferation of Hyalocytes

研究概览

简要总结

ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.

详细描述

Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique.

ILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.

研究设计

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

入排标准

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

入选标准

  • Macular hole or epiretinal Membrane

排除标准

  • Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

结局指标

主要结局

Proliferation of Hyalocytes

时间窗: 9 days

hyalocytes from ERM and ILM will be cultured and counted

次要结局

未报告次要终点

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Head of department, Professor

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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