Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35,000
- 试验地点
- 27
- 主要终点
- Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Europe due to use of perioperative antibiotics
研究概览
简要总结
Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later.
It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.
详细描述
Cataract extraction with intra-ocular lens implantation is the most commonly performed surgical procedure in the elderly population in Europe. The frequency varies in different European Union (EU) countries involving 2 to 7 per 1000 population per annum. A population with an ever-increasing proportion of the elderly is advancing this figure with numbers requiring surgery expected to increase by 70% by 2006. While technical advances (phacoemulsification) have enhanced the efficacy of the procedure, the possibility of serious post-operative infection with loss of vision remains the most important unsolved problem.
In the absence of scientific evidence, the European Society of Cataract and Refractive Surgeons (ESCRS) wishes to determine whether one currently developed method of delivering antibiotics intraocularly in Sweden is of benefit compared to surgery without the use of perioperative antibiotics, as currently practised in many European centres, or to the use of frequent application of topical antibiotic drops perioperatively. The ESCRS also wishes to assess possible risk factors for later endophthalmitis.
This study requires four groups of 8,750 patients - 35,000 in all - to demonstrate reductions of currently reported rates of endophthalmitis (approximately 0.3%) in patients where no intraocular antibiotics are used, or where they are used by the subconjunctival route. Other studies using intraocular vancomycin have reported results as low as 0.05%, but these studies were not standardised or controlled and the results were anecdotal. In addition, vancomycin should not be used for routine prophylaxis and should only be used as the antibiotic of 'last resort'.
This multi-centre randomised study involves 24 operating units in 8 EU countries (Austria, Belgium, England, Germany, Italy, Poland, Portugal and Spain) and Turkey. Results in 8,750 patients receiving an intracameral injection of antibiotic (cefuroxime) at the end of surgery will be compared to 8,750 patients receiving topical antibiotic (levofloxacin) prophylaxis before and at the end of surgery, 8,750 patients receiving the combination and 8,750 patients receiving neither regime; in addition, all patients will receive povidone iodine antiseptic prophylaxis prior to surgery and post-operative levofloxacin from days 1 to 6 to prevent wound infection.
This group size will be sufficiently large to ensure at least 80% statistical power to detect a reduction of incidence from 0.25% to 0.08% using 5% significance level tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
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
- •All patients, including diabetics, undergoing routine cataract surgery in each unit taking part in the study
排除标准
- •Patients who do not wish to take part in the trial
- •Patients allergic to penicillins and cephalosporins.
- •Long-term nursing home patients
- •Patients with only one eye
- •Pregnancy.
- •Children less than 18 years old.
- •All severely 'at-risk' groups for infection including:
- •Severe atopic keratoconjunctivitis;
- •Severe active blepharitis;
- •Ocular cicatricial pemphigoid.
- •Patients with complicated cataracts such as traumatic or subluxated
- •Patients having combined operations with cataract surgery such as trabeculectomy or a corneal graft.
- •Patients known to be allergic to povidone iodine (very rare) or any other known hypersensitivity to any components of the study medications.
- •Patients who are incapacitated mentally and incapable of giving consent.
- •Patients with severe thyroid disease
- •Open infection anywhere, infection of lacrimal drainage channels or infection around the eye
结局指标
主要结局
Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Europe due to use of perioperative antibiotics
Incidence of endophthalmitis in Europe following phacoemulsification cataract surgery
次要结局
- Effect of risk factors on the presentation of endophthalmitis in Europe following phacoemulsification cataract surgery