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临床试验/NCT04562064
NCT04562064Unknown不适用

Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Assiut University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly

研究概览

简要总结

keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases.

Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
  • Contact lens intolerance.
  • Thinnest location is more than 400 um.
  • Maximum keratometry (Kmax) between 48 and 64 D.
  • Clear cornea with no Vogt's striae.

排除标准

  • Previous corneal surgery.
  • Grade IV with corneal scarring.
  • Concurrent corneal disease in addition to KC.
  • Autoimmune or systemic connective tissue diseases.

结局指标

主要结局

The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly

时间窗: 1 month

The changes of anterior corneal surface including flat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abbas

Principal investigator

Assiut University

研究点 (1)

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