A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
研究概览
简要总结
Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥50 to <80 years
- •Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
- •Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included
排除标准
- •<50 or >80 years old
- •Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count <1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements
研究组 & 干预措施
Safety of Intracameral levofloxacin in cataract surgery
Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
干预措施: Safety of intracameral levofloxacin in cataract surgery (Drug)
Safety of Intracameral levofloxacin in cataract surgery
Eligible and recruited patients are randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
干预措施: Use of intracameral cefazolin in cataract surgery (Drug)
Use of intracameral cefazolin in cataract surgery
Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
干预措施: Safety of intracameral levofloxacin in cataract surgery (Drug)
Use of intracameral cefazolin in cataract surgery
Eligible and recruited patients were randomized to intracameral levofloxacin or intracameral cefazolin during cataract surgery
干预措施: Use of intracameral cefazolin in cataract surgery (Drug)
结局指标
主要结局
Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
时间窗: From cataract surgery through to study completion, an average of 1 year
次要结局
未报告次要终点