Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Endothelial Cell Count
研究概览
简要总结
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis
详细描述
Randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
unlabelled syringe containing interventional drug
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eyes undergoing uncomplicated cataract surgery by phacoemulsification
排除标准
- •Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study
研究组 & 干预措施
Intracameral levofloxacin
0.5% unpreserved solution
干预措施: Levofloxacin Ophthalmic (Drug)
Intracameral moxifloxacin
0.5% unpreserved solution
干预措施: Moxifloxacin Ophthalmic (Drug)
结局指标
主要结局
Endothelial Cell Count
时间窗: 3 months
Change in endothelial cell count as measured by specular microscopy
Central Retina Thickness
时间窗: 3 months
Change in central retinal thickness as measured by spectral domain optical coherence tomography
次要结局
- Adverse Events(3 months)
研究者
Harvey Siy Uy
Medical Director
Peregrine Eye and Laser Institute