Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.
研究概览
简要总结
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.
详细描述
The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Have been diagnosed with neovascular AMD, CRVO or BRVO.
- •Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.
排除标准
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •Prior intraocular injection in either eye.
- •Chronic use of opthalmic medication.
- •Contact lens wear.
- •Ocular surgery within the past 6 months.
- •Use of ophthalmic medications in either eye or ocular infection within the past 6 months.
- •Use of systemic antibiotics within 6 months.
- •Known allergy or contraindication to povidone iodine or fluoroquinolones.
结局指标
主要结局
Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.
时间窗: Prior to each of your eye injections for the first 4 injections and continue through the completion of your fourth injection, an anticipated maximum of 6 months.
Evaluating the effects of repeated use of iodine drops with or without antibiotic eye drops on bacteria on the eye surface in patients undergoing injections in the eye to determine if conjunctival bacterial floar are altered or demonstate increasing antibiotic resistance.
次要结局
未报告次要终点
研究者
Michele Formoso
Research Manager
Mid Atlantic Retina