NCT05172349撤回2 期
Pilote Study of the Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Trophic Ulcers
TBF Genie Tissulaire0 个研究点开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
研究概览
简要总结
The purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.
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 between 18 and 80 years old
- •Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included
- •Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies
- •Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion
- •Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting
- •Patient able to understand French language
- •Informed and consenting patient
- •Patient affiliated to a social security system or beneficiary of such a system
排除标准
- •Pregnant or breastfeeding patient or without contraception for non-menopausal women
- •Active infectious ulcer
- •Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm
- •Allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein
- •Current contact lens wear, including scleral lenses
- •NSAID eye drops and any drops containing preservatives
- •Antibiotic, anti-viral, anti-parasitic eye drops
- •Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial
- •Ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study
- •Ophthalmologic pathology requiring daily eye drops
- •Monophtalmic patients
- •Persons deprived of liberty by a judicial or administrative decision
- •Adults who are subject to a legal protection measure or who are unable to express their consent
结局指标
主要结局
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
时间窗: 15 days
Diameter assessed by centralized reading on photograph after fluorescein test
次要结局
- Recovery of the visual acuity evaluated by Monoyer chart(30 days, 45 days)
- Stabilisation or decrease of pain evaluated on visual analog scale(2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days)
- Stable or decreased score for inflammatory and clinical signs of the ocular surface(2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days)
研究者
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