ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Preliminary report of principal results from a European multicenter study
Abstract
PURPOSE: To report results in the European Society of Cataract & Refractive Surgeons (ESCRS) multicenter study of the prophylaxis of endophthalmitis after cataract surgery.
SETTING: Twenty-four ophthalmology units and eye clinics in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom, with an administrative office in Ireland, coordinating center in England, and data management and statistical unit in Scotland.
METHODS: This partially masked randomized placebo-controlled multinational clinical study to evaluate prospectively the prophylactic effect of intracameral cefuroxime injection and/or perioperative levofloxacin eyedrops on the incidence of endophthalmitis after phacoemulsification cataract surgery began in September 2003 and was terminated early in January 2006. The study used random allocation of patients in a 2 x 2 factorial design.
RESULTS: By the end of 2005, complete follow-up records had been received for 13 698 study patients. Such a clear beneficial effect from the use of intracameral cefuroxime had been observed that it was agreed it would be unethical to continue the study and to wait for the completion of all follow-up procedures before reporting this important result. If total reported cases of endophthalmitis are considered, the incidence rate observed in those treatment groups not receiving cefuroxime prophylaxis (23 cases in 6862 patients) was almost 5 times as high (odds ratio [OR], 4.59; 95% confidence interval…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 6,862 participants or records.
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