NCT01906151撤回不适用
A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy
Sensimed AG2 个研究点 分布在 1 个国家开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
研究概览
简要总结
The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients
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
- •Diagnosis of Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field
- •No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0
- •Aged ≥18 years, of either sex
- •Not more than 6 diopters spherical equivalent on the study eye
- •Have given written informed consent, prior to any investigational procedures
排除标准
- •History of acute angle closure glaucoma on the study eye
- •Secondary angle closure glaucoma on the study eye
- •History of ocular surgery within the last 3 months on the study eye
- •History of ocular laser treatment, including previous LPI on the study eye
- •Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye
- •Severe dry eye syndrome on the study eye
- •Patients with allergy to corneal anesthetic
- •Patients with contraindications for silicone contact lens wear
- •Patients not able to understand the character and individual consequences of the investigation
结局指标
主要结局
To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy
时间窗: 24 hours
次要结局
- To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma(24 hours)
- To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma(24 hours)
研究者
研究点 (2)
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