Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study
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
- 否
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
Elshimaa A.Mateen
Assistant Professor
Sohag University
