Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Postoperative IOP
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.
详细描述
This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female, at least 18 years of age
- •Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
- •Ocular Hypertension requiring lowering of IOP
- •ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits
排除标准
- •inability to understand and provide informed consent to participate in this study
- •inability/unwillingness to follow study instructions and complete all required visits
- •Documented allergy to either brimonidine or iopidine
- •Angle Closure Glaucoma
- •Congenital/Juvenile Glaucoma
- •Neovascular Glaucoma
- •Active uveitis
研究组 & 干预措施
I
Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT
干预措施: Apraclonidine 0.5% (Drug)
A
Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT
干预措施: brimonidine 0.1% (Drug)
结局指标
主要结局
Postoperative IOP
时间窗: 1 hour and 1 week post surgery
次要结局
- Overall IOP reduction post SLT(1 month)