Evaluation of SENSIMED Triggerfish Safety and Tolerability in Glaucoma Patients and Glaucoma Suspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Ocular Discomfort
研究概览
简要总结
The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to comply with the study procedures
- •Subject is 18-80 years old
- •Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P<0.05 or a glaucoma Hemifield test "outside normal limits
- •Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (>21 mmHg) but normal and reliable SAP visual fields at baseline
- •Subject 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 the study eye
- •Ability of subject to understand the character and individual consequences of the study
- •For women with childbearing potential, adequate contraception
排除标准
- •Subjects with contraindications for wearing contact lenses
- •Severe dry eye syndrome
- •Keratoconus or other corneal abnormality
- •Conjunctival or intraocular inflammation
- •Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
- •Full frame metal glasses during SENSIMED Triggerfish® recording
- •Known hypersensitivity to silicone, plaster or ocular anesthesia
- •Pregnancy and lactation
- •Simultaneous participation in other clinical studies
研究组 & 干预措施
SENSIMED Triggerfish
干预措施: SENSIMED Triggerfish (Device)
结局指标
主要结局
Ocular Discomfort
时间窗: After 24 hours of device wear
Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.
次要结局
未报告次要终点