"Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Refractive data, visual acuity, topography patterns, pachymetry measurements.
研究概览
简要总结
The purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking , and after, corneal ring surgery.
详细描述
Keratoconus is a progressive disease where cornea is thin and has a higher curvature.In early conditions, it may be corrected by glasses or contact lens.When these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree.
In this study, the patients with a degree of keratoconus on I or II, will be submitted to corneal collagen crosslinking and then a corneal ring surgery.
The corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-UVA irradiation, avoid the progression of the keratoconus.After three months of crosslinking, these patients will be submitted a corneal ring surgery.
These patients will be allowed by two years and various exams will realized them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with keratoconus
- •Patients that aren't using contact lenses
- •Pachymetry more than 400Um
- •Best visual acuity less or equal 20/30
排除标准
- •Ocular surgeries before
- •Other eye diseases
- •Corneal curvature more than 65 dioptres
结局指标
主要结局
Refractive data, visual acuity, topography patterns, pachymetry measurements.
时间窗: Two years
次要结局
- Anterior segment tomography data, corneal biomechanics, impression cytology.(Two years)