Enhanced Pupil Dilation in Patients Taking Alpha-Blockers for Potential Treatment of Intraoperative Floppy Iris Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
研究概览
简要总结
A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
详细描述
This study explores the effects that medication can have on increasing pupil dilation. Pupil dilation size is important for operative eye procedures. Decreased pupil size is related to increased complication risks in eye surgery. By exploring novel pupil dilation techniques, there is a potential to counteract the effects of poor pupil dilation that is caused by medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused by BPH medications. This study evaluates treatment methods targeting IFIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adults (18 years old or greater)
- •History of having taken, or currently taking any systemic alpha blocker
- •Ability to consent themselves
- •Ability to apply eye drops themselves TID for 7 days
排除标准
- •Subjects with untreated hypertension or baseline BP >160
- •Subjects with Thyrotoxicosis
- •Pregnant women or women trying to conceive
- •Inability consent
- •Subjects with anatomical narrow angles or who have never had a dilated eye exam
- •Subjects currently prescribed brimonidine tartrate for glaucoma
- •Subjects who take topical or systemic alpha agonists
- •Patients who take monoamine oxidase (MAO) inhibitors
- •Patients with known severe cardiovascular disease
研究组 & 干预措施
Brimonidine Tartrate 0.2%
One eye was treated with Brimonidine Tartrate 0.2% after a 20-day washout period. Patients will treat right eye 3 times per day for 7 days of treatment.
干预措施: Brimonidine Tartrate (Drug)
结局指标
主要结局
Pupil Dilation Sized of the Treated Eye Compared to the Non-treated Eye
时间窗: 45 minutes post dilation after 7 days of treatment
The primary outcome measure is pupil diameter size post dilation (using standard dilating medications of phenylephrine 10%, tropicamide 1%, and cyclopentolate 1%) of the brimonidine tartrate pre-treated eye compared to the non-treated eye
次要结局
- Change in Pupil Diameter of Each Eye After Dilation at the Start of the Study Compared to Pupil Post Dilating Drops at the End of the Study(45 minutes post dilation after 7 days of treatment)