The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.
研究概览
简要总结
This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.
详细描述
Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The PI measuring pupil size will not know the subject assignment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study
排除标准
- •Diabetic, history of glaucoma
- •history of iris trauma
- •history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
- •Anisocoria
- •pregnancy
研究组 & 干预措施
Alphagan plus
Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
干预措施: Alphagan (Drug)
Alphagan plus
Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
干预措施: Phenylephrine (Drug)
Alphagan plus
Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
干预措施: Tropicamide (Drug)
Tropicamide and Phenylephrine plus
Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
干预措施: Alphagan (Drug)
Tropicamide and Phenylephrine plus
Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
干预措施: Phenylephrine (Drug)
Tropicamide and Phenylephrine plus
Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
干预措施: Tropicamide (Drug)
Tropicamide and Phenylephrine only
Tropicamide and Phenylephrine only arm is given one drop of each times one.
干预措施: Phenylephrine (Drug)
Tropicamide and Phenylephrine only
Tropicamide and Phenylephrine only arm is given one drop of each times one.
干预措施: Tropicamide (Drug)
结局指标
主要结局
Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.
时间窗: 5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.
Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.
次要结局
- Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.(5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.)
- Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours.(5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.)