Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of Spherical equivalent
研究概览
简要总结
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
详细描述
Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.
Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.
Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.
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
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Keratoconus
- •Age ≥ 18 years old
- •Corneal thickness ≥ 400 µm
- •Progressive stage 1 to 3 keratoconus (Krumeich classification)
排除标准
- •Corneal thickness < 400µm
- •Concomitant corneal disease
- •History of corneal surgery
结局指标
主要结局
Changes of Spherical equivalent
时间窗: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
次要结局
- maximum keratometry (K-max) derived from computerized video keratography(01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years)
- Visual acuity(01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years)
- minimum keratometry(01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years)
研究者
Gao Xinbo
Attendant Doctor
Sun Yat-sen University
