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临床试验/NCT06614218
NCT06614218尚未招募不适用

Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review

Sanoculis Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Sanoculis Ltd
入组人数
40
试验地点
1
主要终点
Change in IOP from medicated baseline at 12 months post-MIMS® surgery

研究概览

简要总结

This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eye treated with MIMS® Device as a standalone procedure
  • MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024

排除标准

  • 未提供

结局指标

主要结局

Change in IOP from medicated baseline at 12 months post-MIMS® surgery

时间窗: Medicated baseline at 12 months post-MIMS® surgery

Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery

时间窗: Medicated baseline at 12 months post-MIMS® surgery

Success rate at 12 months post-MIMS® surgery

时间窗: 12 months post-MIMS® surgery

次要结局

未报告次要终点

研究者

发起方
Sanoculis Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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