NCT01828255终止不适用
A Single Center, Case-control, Open Label Study Assessing Intraocular Pressure Patterns in Patients With Primary Open-angle Glaucoma Experiencing Fast Versus Slow Visual Field Progression
Sensimed AG1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
研究概览
简要总结
The purpose of this study is to investigate how the intraocular pressure (IOP) varies in time and if the IOP variations are associated with the worsening of glaucoma. IOP patterns will be recorded continuously over 24 hours with SENSIMED Triggerfish® (TF) a portable investigational device using a contact lens sensor. After completing the Triggerfish lens placement and removal; the patient will complete a formal Polysomnography.
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
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 89 years old
- •Diagnosis of treated POAG (including normal tension glaucoma (NTG))
- •All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
- •Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p<0.01, with at least 1 point at p < 0.005
- •At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%
- •For fast progressing eyes, 1) pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year
- •For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above
- •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
- •Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
- •Corneal or conjunctival abnormality precluding contact lens adaptation
- •Severe dry eye syndrome or other ocular disease
- •Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
- •Patients with previous intraocular surgery in the enrolled eye, including cataract surgery
- •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 unrelated clinical research within the last 4 weeks
结局指标
主要结局
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.
时间窗: 24-hour
24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.
次要结局
- Relationship Between TF Pattern and VF Progression According to Day and Night(24-hour)
- Relationship Between TF Pattern and VF Progression According to TF Slope(24-hour)
- Relationship Between 24-hour TF Pattern and VF Progression According to TF Peak(24-hour)
- 24-hour TF IOP Pattern in Patients With POAG With Fast and Slow Rates of VF Progression(24-hour)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPIGlaucomaNCT01906151Sensimed AG
已完成
不适用
An Open Label Study Assessing the 24-hour Intraocular Pressure Pattern in PAC and PACG Patients, Before and After Laser Peripheral IridotomyGlaucomaNCT01906138Sensimed AG27
已完成
4 期
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular HypertensionOcular HypertensionOpen-Angle GlaucomaNCT01978600Alcon Research89
已完成
不适用
Intraocular Pressure (IOP) and Isometric ExerciseIntraocular PressureNCT00635180Ullevaal University Hospital9
撤回
不适用
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)GlaucomaNCT01495312University of California, San Diego