NCT04000828已完成不适用
Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Amplitude
研究概览
简要总结
A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient must have the willingness and ability to provide signed informed consent
- •Patient is able to comply with the study procedure
- •Patient must be ≥ 18 years old
- •Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye
- •planned trabeculectomy in the study eye
- •in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile
- •Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- •Visual Acuity of 20/200 or better in both eyes
- •Ability of subject to understand the character and individual consequences of the study
排除标准
- •Subjects with contraindications for wearing contact lenses in the study eye
- •secondary glaucoma in the study eye
- •History of refractive surgery in the study eye
- •History of intraocular surgery in the last three months in the study eye
- •Severe dry eye syndrome as judged by the investigator in the study eye
- •Keratoconus or other corneal abnormalities
- •Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision
- •Conjunctival or intraocular inflammation in the study eye
- •Simultaneous participation in other clinical trials
- •Previous IOP-lowering intervention in the study eye
- •Current shift workers (applicable for at least 3 months)
- •Transmeridian flight < 2 months before screening (6 hours time shift)
- •Subjects with pacemaker
结局指标
主要结局
Amplitude
时间窗: up to 14 weeks
Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy
次要结局
- Correlation of other parameters(up to 14 weeks)
研究者
Katrin Lorenz
Head of clinical trial site
Johannes Gutenberg University Mainz
研究点 (2)
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