Studying Corneal Epithelial Stability Following Limbal Stem Cell Transplantation in Cases of Limbal Stem Cell Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- the change of corneal epithelial thickness after stem cell transplantation over 9 months
研究概览
简要总结
Integrity of the corneal epithelium is the function of intact limbal stem cells. The reduction in the population of LSCs and their dysfunction result in abnormal corneal epithelialization and invasion of the corneal surface by the conjunctival epithelium with or without corneal neovascularization that is, limbal stem cell deficiency (LSCD). Different techniques have been developed to treat cases of limbal stem cell deficiency due to traumatic or congenital cases. Recent innovations developed to predict the early stages of stem cell deficiency. One of these methods is measurement of the central epithelial thickness as it was found that limbal stem cell deficiency causes reduction of the central epithelial thickness.
The aim of this study is to study changes in the corneal epithelial thickness at different quadrants of the cornea to observe the exact time of epithelial stability following stem cell transplantation.
详细描述
Patients with unilateral chemical ocular injury will be included in the study(12 eyes). All selected patients will receive a thorough explanation of the study design and aims and informed consent will be obtained in all patients. Eyes of all participants will be subjected to: Best corrected visual acuity, Slit lamp examination and ocular ultrasound if no fundus view.
Staging of degree of limbal stem cell deficiency is done by Roper Hall classification and then the patient will have conjunctival limbal autologous transplant (CLAU).
The patient will be followed up at a week, a month, 3 months, 6months and 9 months postoperative.
Corneal epithelial mapping will be done at the previous schedule in both the donated and the recipient eyes using anterior segment OCT (Optical Coherence Tomography)
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 15 to 70 years
- •Unilateral limbal stem cell deficiency
- •Grade 4 stem cell deficiency
排除标准
- •Cases with extensive symblepharon
- •Cases with very poor visual acuity ( no light perception)
- •Cases with posterior segment problem evident in ocular ultrasonography
结局指标
主要结局
the change of corneal epithelial thickness after stem cell transplantation over 9 months
时间窗: 9 months
Corneal epithelial mapping will be done at one month, 3,6 and 9 months in both the donated and the recipient eyes using anterior segment OCT at the center
次要结局
未报告次要终点
研究者
Fayrouz Aboalazayem
principal investigator
Cairo University