STAR-LIFE: a Post-market Registry on MINIject
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 16
- 主要终点
- ease of use
研究概览
简要总结
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
详细描述
The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years
- •diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
- •able to give consent
排除标准
- •eyes with angle closure glaucoma
- •eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
- •patients with known intolerance or hypersensitivity to silicone
- •patients unable to give consent
结局指标
主要结局
ease of use
时间窗: 1 day
the usability of the device will be defined by use of a surgeon questionnaire.
QoL
时间窗: 2 years after surgery
quality of life will be quantified by use of a standardized quality of life questionnaires SHPC-18
Number of participants with treatment-related incidents
时间窗: up to 2 years after surgery (study completion)
collection of incidences (nature (ocular or non-ocular), number and severity) throughout the study
Unexpected incidents and/or serious reportable incidents
时间窗: From enrollment up to 2 years after surgery (study completion)
Collection of incidents (nature (ocular or non-ocular), number and severity) throughout the study. The number of unexpected incidents and the number of individuals presenting at least one event will be reported.
次要结局
- Surgeon assessment of Device Usability(The surgery day)
- Eye-related Quality of Life Assessed Using the SHPC-18 questionnaire(Baseline, 12 and 24 months)
- IOP measurement(Baseline, 1 day and 1, 3, 6, 12 and 24 months)
- Ocular medication use(From enrollment through 2 years after surgery)
- Investigator Assessment of Ocular Symptoms Using a 6-Category Severity Scale(From enrollment until 2 years post-surgery)
- BCVA testing(Baseline, 1, 3, 6, 12, 24 months)
- Visual field(Baseline, 6, 12 and 24 months)
- Additional ocular surgery post-implantation(From surgery until 2 years post-surgery)