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临床试验/NCT02721628
NCT02721628Unknown不适用

Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月1日最近更新:
适应症

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

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

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xinbo

Attendant Doctor

Sun Yat-sen University

研究点 (1)

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