跳至主要内容
临床试验/NCT05596838
NCT05596838进行中(未招募)不适用

Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

Elsan1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
试验地点
1
主要终点
Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.

研究概览

简要总结

Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.

Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.

The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patient having received the information notice/non-objection
  • Adult man or woman (over 18)
  • Failure of a lens fitting adaptation
  • Patient with a diagnosis of keratoconus
  • Patient operated at Somain institute with the placement of intra-corneal rings

排除标准

  • Post-lasik ectasia
  • Iatrogenic Keratoconus
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

结局指标

主要结局

Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR.

时间窗: 1 year

Evolution of the best corrected visual acuity (BCVA) 1 year after the installation of intra-corneal rings compared to the preoperative value. Visual acuity will be expressed in logMAR.

次要结局

未报告次要终点

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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