对针对波士顿角质假体的临床试验的审查
Daniel Milad1, Yelin Yang1, Kerolos Eisa2
1Department of Ophthalmology, University of Montreal Health Centre (CHUM), Montreal, QC.
概括
波士顿角膜假体 (KPro) 的临床试验很少,这是治疗严重角膜疾病的设备. 需要更多的长期研究来比较KPro与重复的角膜移植,以更好地照顾患者.
科学领域:
- 眼科医生 眼科 眼科
- 生物材料科学 生物材料科学
背景情况:
- 波士顿角膜假体 (KPro) 是当传统的角膜移植失败时严重的角膜疾病的替代方案.
- 对于KPro,临床试验数据有限,影响基于证据的决策.
研究的目的:
- 对波士顿角质假肢 (KPro) 的现有临床试验进行审查.
- 确定正在进行的试验,并评估KPro.Pro的当前证据基础.
主要方法:
- 对KPro发表的临床试验进行了系统的文献审查.
- 在主要数据库 (PubMed,Ovid MEDLINE,Cochrane CENTRAL,ClinicalTrials.gov) 进行了搜索,截至2021年9月.
- 考克莱恩偏差风险工具 (RoB2) 用于评估试验质量.
主要成果:
- 确定了六项已发表和六项正在进行的KPro临床试验,患者人数从8人到37人不等.
- 一半的KPro试验是随机的,其中包括初级使用和移植后失败.
- 试验质量有所不同,50%的试验具有偏差的低风险,33%的试验存在一些担忧,17%的试验具有偏差的高风险.
结论:
- 波士顿角质假体 (KPro) 的已发表和正在进行的临床试验很少.
- 没有任何试验直接将KPro结果与重复角膜移植进行比较.
- 高质量,长期的临床试验对于有关KPro使用的临床决策至关重要.
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