Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- IOP reduction
研究概览
简要总结
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism
详细描述
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male and female patients, at least 18 years of age
- •Subject has a clear understanding and agrees to all the conditions of the informed consent form
排除标准
- •Subjects shall be selected in accordance with the following exclusion criteria
- •Subject has undergone ocular surgery within the last 3 months
- •Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- •Pregnant or nursing women
- •Those who have had corneal surgery including corneal laser surgery
- •Microphthalmos
- •Buphthalmos
- •Severe Dry eyes
- •Lid squeezers - blepharospasm
- •Nystagmus
- •corneal or conjunctival infection.
研究组 & 干预措施
lataprost
latanoprost use
干预措施: CATS Tonometer (Device)
timolol
timolol group
干预措施: CATS Tonometer (Device)
timolol
timolol group
干预措施: Latanoprost (Drug)
结局指标
主要结局
IOP reduction
时间窗: 1 month
次要结局
未报告次要终点