Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Increase of corneal thickness
研究概览
简要总结
Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.
详细描述
Knowing the importance of stroma(90%) in function and anatomy of corneae (transparence, curvature, strength, protection) the inner eye structures from external environment, we have examined the role and function of stroma as a main factor of corneal thickness in implanting fresh corneal lenticule in progressive corneal disease.
We have studied that in many clinical cases where the corneal epithelium and endothelium are healthy and functioning, the cornea can still lose it's transparency by different corneal stromal pathologies (infection ,keratoconus, inflammation ,neurodegeneration and corneal dystrophies).
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •progressive corneal disease with thin corneal thickness
- •corneal low transparenc
- •low visual acuity
排除标准
- •active anterior segment pathology
- •previous corneal or anterior segment surgery
- •other infection etc.
研究组 & 干预措施
FRESH CORNEAL LENTICULE IMPLANTATION
The aim in our study is to describe the importance of stroma as criteria of corneal thickness at implanting human fresh corneal lenticule in progressive corneal disease.
We have conclude that every biomechanical instability of corneal stroma function(abnormal increase collagen activity,decrease proteinase inhibitors,excessive premature keratocyte apoptosis) describe the role of stroma in corneal thickness.
干预措施: ReLex-smile (Device)
结局指标
主要结局
Increase of corneal thickness
时间窗: 24 months
Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes
次要结局
未报告次要终点
研究者
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo