Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360,000
- 主要终点
- Frequency of occurrence of endophthalmitis
研究概览
简要总结
Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.
Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.
Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.
The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
- •associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
- •between February 2007 and November 2015
排除标准
- •intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
- •risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code
结局指标
主要结局
Frequency of occurrence of endophthalmitis
时间窗: Up to 28 days following an intravitreal injection
次要结局
未报告次要终点