A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT.
研究概览
简要总结
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.
The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open angle glaucoma (POAG) including pigmentary glaucoma or pseudoexfoliative glaucoma (PEX)
- •Documented glaucomatous VF damage (in the previous 8 months) with mean defect (MD) > 2.5 dB
- •No or stable anti-glaucomatous drug therapy since at least 3 months
- •Structural and/or functional glaucomatous damage
- •Aged more than 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 procedures
排除标准
- •Refractory glaucoma
- •Patients having undergone ocular laser procedures or intraocular surgery for the treatment of glaucoma
- •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
- •Any other contra-indication listed in the Triggerfish user manual
结局指标
主要结局
To evaluate the differences between the nycthemeral IOP patterns recorded with Triggerfish, during two 24-hour periods in patients with POAG, before and after SLT.
时间窗: 1 months
* Wake-to-Sleep slopes * Overall variability * Diurnal and nocturnal IOP patterns * Number of peaks
次要结局
- To assess IOP patterns of POAG patients during office hours(1 month)
- Safety and tolerability in this patient population(1 month)