2024-517572-38-00招募中4 期
Comparison of treatment with preservative-free dexamethasone 0.1% (Monofree Dexamethason) and diclofenac 0.1% (Dicloabak) eye drops versus preserved dexamethasone 0.1% (Maxidex) and diclofenac 0.1% (Voltaren Ophtha) eye drops after cataract surgery.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the primary endpoint will be the superiority of group without conservative (WC) on group with conservative (C) on aqueous flare value at week 4 after cataract surgery
研究概览
简要总结
Comparison of treatment with preservative-free eye drops versus preserved eye drops after cataract surgery
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •patients diagnosted with age-related cataract
- •Age 60 years or above
排除标准
- •Pre-existing dry eye disease according to the criteria's of the TFOS DEXS II report
- •pseudoexfoliation syndrome
- •functionally monocular patient
- •any use of eye drops during at least 3 months before surgery with exception of artificial tears
- •previous ocular injury, surgery or laser treatment, uveitis
- •presence of any macular disease possibly impacting visual acuity
结局指标
主要结局
the primary endpoint will be the superiority of group without conservative (WC) on group with conservative (C) on aqueous flare value at week 4 after cataract surgery
the primary endpoint will be the superiority of group without conservative (WC) on group with conservative (C) on aqueous flare value at week 4 after cataract surgery
次要结局
- tear osmolarity
- conjunctival hyperemia
- corneal fluorescein staining
- tear-film breakup time
- corneal sensitivity
- central macular thickness
- DEQ-5 score
- inflammatory cytokine activities in tears
- amount of tears
- effect of conservatives on the ocular surface microbiome post cataract surgery
研究者
Clinical Trial Center
Scientific
UZ Leuven
研究点 (1)
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