Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Rate of tectonic success of the graft at 3 months
研究概览
简要总结
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
详细描述
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
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
- •Male or female, aged 18 to 80 years.
- •Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
- •Patient with loss of substance < 3cm
- •Patient able to understand, sign and date the informed consent form.
- •Patient who is a member or a beneficiary of a national health insurance plan.
排除标准
- •Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- •Patients with uncontrolled infectious risk.
- •Patient with an autoimmune disease.
- •Person deprived of liberty by a judicial or administrative decision.
- •Person under forced psychiatric care.
- •Person admitted to a health or social institution for purposes other than the research.
- •Adult subjected to a legal protection measure or unable to express his / her consent.
研究组 & 干预措施
SclerFIX
Patch of umbilical cord lining membrane sutured on top of the scleral defect.
干预措施: SclerFIX (Biological)
结局指标
主要结局
Rate of tectonic success of the graft at 3 months
时间窗: 3 months
The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface \> 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).
次要结局
- Absence of inflammatory reactions and good local tolerance of the implant(15 days, 1 month, 3 months)
- Evaluation of the visual acuity(15 days, 1 month, 3 months)
- Evaluation of the eye pressure(15 days, 1 month, 3 months)