A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
研究概览
简要总结
The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OHT (IOP >21 mmHg on 2 consecutive visits) in the study eye
- •No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study
- •Aged ≥ 18 years, of either sex
- •Not more than 6 diopters spherical equivalent in the study eye
- •Having given written informed consent, prior to any investigational procedures
排除标准
- •Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
- •History of ocular surgery on the study eye (except cataract extraction)
- •History of laser treatment on the study eye
- •Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation
- •Severe dry eye syndrome
- •Subjects with irregular sleep schedules
- •Subjects who are current smokers
- •Subjects with allergy to corneal anesthetic
- •Subjects with contraindications for silicone contact lens wear
- •Subjects 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 TF user manual
结局指标
主要结局
Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
时间窗: 24 hours
For each subject, TF acrophase (ie. time when peak occured) was scored dichotomously (before and after 7 am) and compared between OHT converters and non converters patients. One subject was removed from the analysis because of invalid TF output.
次要结局
- Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)(24 hours)
- Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements(24 hours)