A Two Different Chemoprophylaxis Approaches After Phacoemulsification Surgery in One Thousand Patients in Iraq :a Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 主要终点
- Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries
研究概览
简要总结
Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome.
The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC) antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most common pattern in the United state(US). The current study aimed to evaluate the effectivity and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five hundred phacoemulsification surgeries and compare its results with the same number of patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given four times a day for 1month postoperatively.
详细描述
Study design and populations:
The current clinical trial included a total 1000 patients with visually significant cataract scheduled to have phacoemulsification surgery at an Eye specialty private hospital in Baghdad /Iraq during 18 months period from 1st of October 2016 to 1st of February 2018 by two surgeons.
The current two methods of prophylaxis of postoperative endophthalmitis and inflammation were discussed with the patients and informed consent was obtained about the treatment and the enrollment in the current study.
Two methods of prophylaxis of postoperative bacterial endophthalmitis and inflammation were planned to use. For 500 patients (group 1) topical moxifloxacin hydrochloride 0.5% (Vigamox,Alcon) and dexamethasone 0.1%(Maxidex, Alcon) eye drops prescribed four times a day for 1-month postoperatively ,while for the remaining 500 patients (group 2), intracameral (IC) diluted moxifloxacin 0.1% and subconjunctival triamcinolone acetonide 4 mg/0.4 cc is the combination that planned to used for prophylaxis.
Preoperative evaluations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for both groups; the patients with visually significant cataract were included in the current study should have
- •no current or previous intraocular inflammation,
- •no history of glaucoma or topical corticosteroid responsiveness.
- •All the included patients had normal preoperative fundus examination and normal preoperative macular OCT.
- •All the patients who have the above-mentioned inclusion criteria were included in the current comparison whether phacoemulsification surgery was complicated or not.
排除标准
- •For group 2; any patient used a topical antibiotic, nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid up to 1 week before the planned day of surgery,
- •any patient with a history of glaucoma or steroid responsiveness
- •any patient with significant maculopathy were excluded from the current comparison.
研究组 & 干预措施
Topical
Moxifloxacin hydrochloride 0.5% eye drops and dexamethasone 0.1% eye drops were prescribed four times a day for 1 month postoperatively.
干预措施: Moxifloxacin hydrochloride 0.5% eye drops (Drug)
Topical
Moxifloxacin hydrochloride 0.5% eye drops and dexamethasone 0.1% eye drops were prescribed four times a day for 1 month postoperatively.
干预措施: Dexamethasone 0.1% eye drops (Drug)
Intracameral - Subconjunctival
Intracameral Moxifloxacin 0.1% with Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml had been administered at the conclusion of the surgery
干预措施: Intracameral Moxifloxacin 0.1% (Drug)
Intracameral - Subconjunctival
Intracameral Moxifloxacin 0.1% with Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml had been administered at the conclusion of the surgery
干预措施: Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml (Drug)
结局指标
主要结局
Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries
时间窗: The duration of follow up for each patient was a 3 months postoperatively.
All patients assessed by slit lamp examination for possibility of early or late onset bacterial endophthalmitis after phacoemulsification surgery.
次要结局
- Intraocular pressure(IOP) was measured on 1week,1month,and 3 months visits by Goldmann applanation tonometry .(The duration of follow up for each patient was a 3 months postoperatively.)
研究者
Suzan A Rattan
Assistant professor in ophthalmology
Al-Kindy College of Medicine