Evaluation and Comparison of Macular and Choroidal Thickness After Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of Macular Thickness
研究概览
简要总结
The objective of this study is to evaluate the macular and choroidal thickness of patients submitted to intracameral moxifloxacin during the phacoemulsification surgery for endophthalmitis prophylaxis.
The investigators propose a randomized clinical trial double-blind. The patients will be divided into two groups: one will receive intracameral moxifloxacin injection during phacoemulsification surgery and the other won't.
Both Spectral Domain - Optical Coherence Tomography (SD-OCT) and Enhanced Depth Imaging - Optical Coherence Tomography (EDI-OCT) will be performed for each patient pre-operatively and on the 30th and 60th postoperative days.
After collecting, the data will be compared to evaluate if there was any difference in the macular thickness and choroidal thickness between the two groups.
详细描述
Title:
Evaluation and Comparison of Macular and Choroidal Thickness after Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Purpose:
The objective of this study is to evaluate if the using of intracameral moxifloxacin cause changes in macular and choroidal thickness.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the patients and the investigator will be masked. The cataract surgeon won't be.
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
- •Any patients that will be submitted to phacoemulsification surgery in the Hospital de Clinicas of State University of Campinas (BRAZIL)
- •Patients over 18 years old
- •Patients who are able to perform SD-OCT
- •Patients who sign the consent form
排除标准
- •Diabetic patients
- •Patients with any macular changes prior to the surgery (epiretinal membranes, age macular disease, macular edema...)
- •Patients who had any complication during phacoemulsification surgery
研究组 & 干预措施
Intracameral moxifloxacin
Injection of 0,03ml of moxifloxacin in the anterior chamber following phacoemulsification surgery
干预措施: Moxifloxacin Injection (Drug)
结局指标
主要结局
Change of Macular Thickness
时间窗: Change from baseline, 30th day postoperative and 60th day postoperative
Comparison of change in macular thickness using Spectral Domain - Optical Coherence Tomography
次要结局
- Change of Choroidal Thickness(Change from baseline, 30th day postoperative and 60th day postoperative)
研究者
Rodrigo Pessoa Cavalcanti Lira
Professor
Universidade Federal de Pernambuco