Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Correlation analyses between mean central corneal thickness (CCT) and 24-hour intraocular pressure (IOP) fluctuation and between mean CCT and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost.
研究概览
简要总结
The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a 4-weeks period of treatment.
Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis (CH) measured by Ocular Response Analyzer (ORA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females >50 years old with:
- •Primary Open-Angle Glaucoma newly diagnosed or with anti-glaucoma medical treatment < =12 weeks
- •Pseudoexfoliative Glaucoma newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks
- •Ocular Hypertensives newly diagnosed or with anti-glaucoma medical treatment <= 12 weeks
- •Age-matched controls
- •IOP>=22mmHg at the eligibility visit for glaucoma patients and ocular hypertensives
排除标准
- •Use of any ophthalmic medication (drops) during the study (except for natural tears)
- •Inflammation of any aetiology
- •Previous eye surgery or laser
- •Corneal abnormalities (oedema, dystrophies etc) For Subjects
- •Systemic diseases which affect the cornea (such as autoimmune diseases)
- •Inability to participate due to advanced age or serious illness
- •Mean IOP>36mmHg in either eye at the eligibility visit.
- •Subjects who cannot safety discontinue use of all IOP-lowering medication(s) for washout
- •Subjects with severe central visual field loss in either eye. Severe central visual field loss is defined as sensitivity <=10dB in at least 2 of the 4 visual field test points closest to the point of fixation
- •Other types of glaucoma (such as angle-closure glaucoma and secondary glaucomas)
研究组 & 干预措施
Ocular hypertensives
This study includes two groups.
- Subjects with ocular hypertension and
- Controls. Group 2 undergoes only 1 visit (visit 1) without any intervention. Group 1 undergoes visit 1 without intervention. Then they receive treatment (1 eyedrop of latanoprost (0.005%) dosed once a day in both eyes at 8:00pm for a 4-weeks period for 1 month) and undergo the visit 2 under the effect of treatment.
干预措施: Latanoprost (Drug)
结局指标
主要结局
Correlation analyses between mean central corneal thickness (CCT) and 24-hour intraocular pressure (IOP) fluctuation and between mean CCT and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost.
时间窗: Before and after a 4-weeks period of treatment with latanoprost.
次要结局
- Correlation analyses between corneal hysteresis (CH) and 24-hour intraocular pressure (IOP) fluctuation and between CH and mean IOP reduction from baseline after a 4-weeks period of treatment with latanoprost.(Before and after a 4-weeks period of treatment with latanoprost.)
研究者
Fotis Topouzis
Professior
Aristotle University Of Thessaloniki