跳至主要内容
临床试验/NCT06498570
NCT06498570已完成不适用

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study

Sohag University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
K1 and K2 post-operative by Pentacam

研究概览

简要总结

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

详细描述

a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.

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
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • stable keratoconus.
  • corneal cross-linking performed at least 6 months.
  • contact lens intolerance
  • minimum corneal thickness of 350 μm at the thinnest point (TP)
  • mean keratometry (K mean) value less than 59 D

排除标准

  • any other associated ocular or systemic pathology could affect the vision.

结局指标

主要结局

K1 and K2 post-operative by Pentacam

时间窗: one year

Flat and Steep K in Diopter post ring implantation

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

Elshimaa A.Mateen

Assistant Professor

Sohag University

研究点 (1)

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