NCT06264024招募中不适用
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年2月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Risk of progression
研究概览
简要总结
The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.
The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
- •Progressive keratoconus with indication for CXL
- •Corneal thickness ≥ 420 μm
排除标准
- •Other eye disease causing visual impairment
结局指标
主要结局
Risk of progression
时间窗: 1 year after surgery
Change in keratometric values
Visual acuity
时间窗: 1 month after surgery
Uncorrected and corrected distance visual acuity in logMAR
次要结局
- Visual acuity(5 years after surgery)
- Depth of demarcation line (confocal microscopy)(1 month after surgery)
- Patient reported outcome measure (PROMs)(2 years after surgery)
- Risk of progression(5 years after surgery)
- Depth of demarcation line (OCT)(1 month after surgery)
- Patient reported pain after surgery(48 hours after surgery)
研究者
Olav Kristianslund
MD, PhD
Oslo University Hospital
研究点 (1)
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