Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 主要终点
- Reconstruction of Ocular surface in patients with symblepharon
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon.
详细描述
10 patients will be included from 16 to 90 years with presence of symblepharon, what have been already subjected to proceedings of reconstruction of the ocular surface without success and to present conjunctival healthy. In the place of biopsy and after the surgery of the patient one will be applied ointment with antibiotic and corticoid to minimize the inflammatory effects. The fragments will be transported even it laboratory of Molecular Biology of the advanced Centre of Ocular Surface where it will be prosecuted by means of technique sterile under laminating flow. The conjunctival epithelias cells will be put on the amniotic membrane compartments of the plate of culture where the appropriate ways will be added. After 2 weeks the membranes colonized with epithelium conjunctival they will be subjected to the coloration and the cloth will be used for the surgery of reconstruction of the ocular surface. It will be carried out first us an evaluation ophthalmologic complete weekly, 2 months and then fortnightly up to the sixth month post-operative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with ocular surface disorders, e.g. symblepharon
- •Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- •Only one eye of a patient will be eligible for study entry.
- •Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
- •Patients who are willing to undergo long-term follow-up, as outlined in this protocol
- •Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
排除标准
- •Patients less than 16 years of age
- •Patients who are incapable, either by law or of mental state, of giving consent in their own right
- •Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- •Patients who are pregnant or breastfeeding
- •Patients with a history of drug allergy
- •Patients who have received an investigational drug within 28 days preceding surgery
- •Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
- •Patients who are documented to be steroid responders
结局指标
主要结局
Reconstruction of Ocular surface in patients with symblepharon
时间窗: 6 months
次要结局
- Re - reconstruction of Ocular surface in patients with symblepharon(6 months)