Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Endothelial cell density
研究概览
简要总结
The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile.
Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.
详细描述
This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant will be masked receiving treatment, post operative eye drops of both arms is the same. Subject allocation is blinded to investigator and outcomes assessor.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Immature senile cataract in one or both eye
- •Agree to be included and signed informed consent
排除标准
- •Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics
- •Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders
- •Ocular surgery prior to study
- •Sign of infection or inflammation around the eye
- •Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading
- •Corneal endothelial cell density < 1500 cell/ mm2
- •Anterior chamber depth < 2.5 mm
- •Diabetes mellitus type 2
研究组 & 干预措施
Moxifloxacin
Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.
干预措施: Moxifloxacin Ophthalmic Solution (Drug)
Levofloxacin
Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.
干预措施: Levofloxacin Ophthalmic (Drug)
结局指标
主要结局
Endothelial cell density
时间窗: 1 month
Corneal endothelial cell density measured using specular microscopy
次要结局
- Central corneal thickness(1 month)
- Intraocular pressure(1 month)
- Central macular thickness(1 month)
- Anterior chamber cell reactions(1 month)
研究者
Arcci Pradessatama
Ophthalmology Department Resident
Indonesia University