Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Change in Post-Injection Intraocular Pressure Spike
研究概览
简要总结
In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.
详细描述
A total of 55 consecutive patients undergoing anti-VEGF intravitreal injections (received ≥1 treatments) for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO) will be prospectively recruited between December 2016 and July 2017. Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the first or second of two consecutive visits. A standard protocol for sterile preparation with topical 5% povidone-iodine solution will be followed. Pre-injection IOP measurements will be recorded prior to the instillation of dilating agents and brimonidine tartrate. A total of three IOP measurements will be taken by certified ophthalmic technicians at immediately after the injection (T0), 10 minutes after (T10) and 20 minutes after (T20) injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •received ≥1 treatments for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO)
排除标准
- •baseline diagnosis of glaucoma
- •baseline IOP during last visit of greater than 21 mmHg
- •ongoing use of topical medications (eg. corticosteroids)
- •pseudophakic with an anterior chamber intraocular lens
- •history of ocular conditions that may impact IOP (eg. pseudoexfoliation)
- •previous in-office (eg. laser peripheral iridotomy) and vitreoretinal surgical procedures (eg. pars plana vitrectomy).
研究组 & 干预措施
Brimonidine Pre-Administration During First Visit
干预措施: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) (Drug)
Brimonidine Pre-Administration During Second Visit
干预措施: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) (Drug)
结局指标
主要结局
Change in Post-Injection Intraocular Pressure Spike
时间窗: Change from immediately, 10 minutes and 20 minutes after injection
the intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF injection
次要结局
未报告次要终点
研究者
Tina Felfeli
Medical Student
University of Toronto