NCT05968443已完成不适用
Observational, Retrospective Clinical Study in Patients Undergoing Ophthalmic Surgery Using Dafilon® Suture Material (Dafilon® USP (United States Pharmacopeia) Sizes From 8/0 to 11/0)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Suture material complications
研究概览
简要总结
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon® suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital
排除标准
- •No exclusion criteria have been set
结局指标
主要结局
Number of Suture material complications
时间窗: up to the retrospective examination (2 to 4 years postoperatively)
Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
次要结局
- Number of Intra-operative complications(intraoperatively)
- Incidence of recurrence(up to the retrospective examination (2 to 4 years postoperatively))
- Number of Post-operative complications(up to the retrospective examination (2 to 4 years postoperatively))
研究者
研究点 (1)
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