跳至主要内容
临床试验/NCT02857881
NCT02857881终止不适用

Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)

研究概览

简要总结

Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology, characterized by a progressive corneal thinning. This disease leads to a bombing of the cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL) and simple corneal de-epithelization are two common surgical technics aiming to slow the progression of this pathology. They consist in rigidifying the corneal structure in order to stabilize its deformation progression. Even though these technics are commonly performed, none of these strategies has proven their efficiency. The effects of CXL can be due to the superficial scarring reaction as well as the effects of corneal remodeling induced by the de-epithelization phase during a CXL procedure, and not due to the covalent links between collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition in the presence of Riboflavine De-epithelization may be an equally effective treatment, when compared to CXL, but without long term secondary effects. Its association with a therapeutic photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate its opacities in order to recuperate the transparency of the cornea) will aim to improve the regularity of the anterior corneal surface, thus allowing a better epithelial attachment (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency in the treatment of keratoconus.

The purpose of this study is to describe the effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1 year, after an intervention of de-epithelization associated with therapeutic photokeratectomy.

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
15 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 15 to 45 years old
  • Patients with an evolutive keratoconus
  • Planned intervention (de-epithelization and photokeratectomy)

排除标准

  • Contra-indication to de-epithelization (active scarring corneal lesion)
  • Pregnant women and breastfeeding
  • Absence of the written consent to participate in the trial

研究组 & 干预措施

Evolutive keratoconus

Experimental

干预措施: De-epithelization and therapeutic photokeratectomy (Procedure)

结局指标

主要结局

Evolutivity of keratoconus (Proportion of patients who lost the evolutivity of their keratoconus)

时间窗: 6 months

Effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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