NCT01906138已完成不适用
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 个国家目标入组 27 人开始时间: 2013年7月1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
- 27
- 试验地点
- 2
- 主要终点
- The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
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 (PAC is defined by the presence of a partial or complete iridotrabecular contact in more than 2 quadrants with either raised intraocular pressure [i.e. more than 21 mmHg] and/or primary adhesion to the trabecular meshwork (peripheral anterior synechiae [PAS]; however, with normal optic disc and visual field. PACG is defined by the presence of iridotrabecular contact with either raised intraocular pressure and/or PAS, and evidence of glaucomatous optic disc and visual field)
- •No intraocular pressure-lowering drug treatment or a 4-week wash-out period prior to study day 0 and throughout the study
- •Aged ≥18 years, of either sex
- •Not more than 6 diopters spherical equivalent on the study eye
- •Not more than 2 diopters cylinder equivalent on the study eye
- •Have given written informed consent, prior to any investigational procedure
排除标准
- •History of acute angle closure glaucoma
- •Secondary angle closure glaucoma
- •History of ocular surgery within the last 3 months
- •History of ocular laser treatment, including previous laser peripheral iridotomy
- •Corneal or conjunctival abnormality precluding contact lens adaptation
- •Severe dry eye syndrome
- •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
- •Participation in other clinical research within the last 4 weeks
结局指标
主要结局
The 24-hour Intraocular pressure pattern as recorded by Triggerfish in patients with Primary Angle Closure and Primary Angle Closure Glaucoma
时间窗: 24 hours
次要结局
- To assess the nycthemeral Intraocular pressure patterns specific to PAC and PACG(24 hours)
- To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern for each group of patients(24 hours)
- To assess the comfort of contact lens sensor wear in patients of Indian origin(24 hours)
研究者
研究点 (2)
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