NCT05055349Unknown不适用
"Comparison Between Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus"
Minia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- pentacam readings
研究概览
简要总结
To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus
详细描述
- The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.
- Fourty eyes will be evenly allocated into two groups:
Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.
Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).
• An informed written consent to be involved in the study will be obtained from each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keratoconus grade I to III according to the Amsler-Krumeich classification
排除标准
- •Acute hydrops or grade IV keratoconus
- •Any ocular diseases or surgeries
- •Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
- •Corneal pacities
结局指标
主要结局
pentacam readings
时间窗: 1 month
a device that read topometric corneal data and other data
次要结局
未报告次要终点
研究者
Ahmed Maher Khalafallah
Principal Investigator
Minia University
研究点 (1)
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