Safety and Efficacy of Topical Moxifloxacin for Prevention of Post-Traumatic Endophthalmitis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings
研究概览
简要总结
Open globe injuries (OGI) are among the main causes of blindness or irreversible severe reduction in visual acuity in the world. An estimated 2.3 million people live with bilateral low vision and nearly 19 million live with blindness or unilateral low vision due to such trauma. Pre-surgical prophylaxis to prevent serious infectious complications such as endophthalmitis is frequently performed, however, there are discrepancies in its performance between services as there is no proven superior protocol. Different combinations of antibiotics and administration routes are currently used.
The aim of this study is to evaluate the efficacy and safety of the use of topical moxifloxacin 0.5% ophthalmic solution (Vigamox®) in the prophylaxis of acute endophthalmitis in patients with OGI. This is a prospective, controlled, randomized, single-center study conducted in patients diagnosed with OGI at the Clinical Hospital of São Paulo State University, Campinas.
Volunteers who present OGI and sign the informed consent form (ICF) will be randomized into 2 groups: in group A, volunteers will undergo pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.
In group B, the volunteers will receive pre-surgical prophylaxis as it is currently done in the service, with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, prior to surgery. Intraoperative and post-surgical care will be the same for both groups and will continue to be carried out in line with the current service protocol. Patients will be followed for 45 days, with a complete ophthalmological evaluation that aims to verify the incidence of endophthalmitis in both groups. It is expected to find an equal or lower incidence of endophthalmitis in the group that received topical administration of moxifloxacin.
详细描述
Patients diagnosed with OGI that requires surgery will be evaluated regarding visual acuity, biomicroscopy and fundoscopy, considering that the latter may not be possible in some cases due to the trauma severity. Those who, after being informed about all aspects of the surgery and this study, sign the ICF will be randomly divided into 2 groups of approximately equal sizes stratified by gender. Group A will receive, throughout the preoperative period, instillation of 0.5% moxifloxacin eye drops, 01 drop every 3 hours until the time of surgery. Group B will receive intravenous use of cefazolin 1 gram every 6 hours and ciprofloxacin 400mg every 12 hours.
The primary outcome is to evaluate the incidence of endophthalmitis in each group. The secondary outcome is to assess the other possible postoperative complications such as corneal decompensation and development of glaucoma and cataract, as well as analysis of the epidemiological profile of patients.
All patients will be hospitalized throughout the preoperative period, waiting for urgent surgery. All patients will remain with a non-compressive occlusive dressing during the preoperative period, being removed intraoperatively. The dressing will be removed and replaced only for the instillation of eye drops in patients allocated to group A. The surgery to correct OGI will be performed as already standardized in the Ophthalmology service at UNICAMP, by residents of the 3rd and 4th years, as well as assistant physicians and professors for cases of greater complexity and supervising all surgical procedures. The anesthetic technique will be performed according to the current protocol with general anesthesia. Skin antisepsis will be done with 10% aqueous povidone-iodine solution and then sterile surgical drapes will be placed with the eyelashes isolated.
The surgical technique will vary according to the trauma mechanism and the degree of ocular involvement, being defined by the preoperative surgical indication, but it may undergo changes according to the intraoperative evaluation.
Patients in both groups who present involvement of the lens and require its removal during surgery (facectomy) will receive an injection of 0.03ml of 0.5% moxifloxacin intracameral at the end of the surgery, as already standardized in the hospital. For the other cases, in which the lens is not affected, there will be no intracameral injection of 0.5% moxifloxacin.
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
- None
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
- •Open globe injury
排除标准
- •Under 18 years old
- •Requires intravenous antibiotics for other reasons
- •Moxifloxacin allergy
- •Imunossupressed patients
- •Pregnant women
研究组 & 干预措施
Topical Moxifloxacin
Pre-surgical prophylaxis with the use of topical 0.5% moxifloxacin eye drops every 3 hours until the surgery.
干预措施: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution (Drug)
Intravenous Cephazolin and Ciprofloxacin
Pre-surgical prophylaxis with cefazolin 1 gram every 6 hours and ciprofloxacin 400 milligrams intravenously every 12 hours, until the surgery.
干预措施: Ciprofloxacin 400 MG/200 ML Intravenous Solution [CIPRO IV] (Drug)
结局指标
主要结局
Number of participants that develop post-traumatic acute endophthalmitis in each group as assessed by a retina specialist according to clinical exam and ultrasonography findings
时间窗: Will be considered post-traumatic acute endophthalmitis if the patient evolve the condition until 45 days after open globe injury surgery
Post-traumatic endophthalmitis incidence rate in each group ( group A: topical moxifloxacin and group B: intravenous cefazolin plus ciprofloxacin)
次要结局
未报告次要终点
研究者
Mathias Violante Mélega
Principal Investigator
University of Campinas, Brazil