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 [CI], 1.74-12.08; P = .002) as that in the groups receiving this treatment (5 cases in 6836 patients). If only cases proved to be due to infection are considered, the rate was more than 5 times as high (OR, 5.32; 95% CI, 1.55-18.26; P = .008) in the treatment groups not receiving cefuroxime. Although the use of perioperative levofloxacin eyedrops as prophylaxis was also associated with a reduction in the observed incidence rate of postoperative endophthalmitis, this effect was smaller and was not statistically significant, whether total reported cases or only cases proven to be due to infection are used in calculating the rates. As not all follow-up procedures are complete, it is possible that further cases of endophthalmitis may be reported; however, it is not expected that this will alter the main conclusion. Nevertheless, it is anticipated that successful completion of follow-up procedures in all patients will increase the total number in the study to approximately 16,000. CONCLUSION:Intracameral cefuroxime administered at the time of surgery significantly reduced the risk for developing endophthalmitis after cataract surgery.
RCT Entities:
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 [CI], 1.74-12.08; P = .002) as that in the groups receiving this treatment (5 cases in 6836 patients). If only cases proved to be due to infection are considered, the rate was more than 5 times as high (OR, 5.32; 95% CI, 1.55-18.26; P = .008) in the treatment groups not receiving cefuroxime. Although the use of perioperative levofloxacin eyedrops as prophylaxis was also associated with a reduction in the observed incidence rate of postoperative endophthalmitis, this effect was smaller and was not statistically significant, whether total reported cases or only cases proven to be due to infection are used in calculating the rates. As not all follow-up procedures are complete, it is possible that further cases of endophthalmitis may be reported; however, it is not expected that this will alter the main conclusion. Nevertheless, it is anticipated that successful completion of follow-up procedures in all patients will increase the total number in the study to approximately 16,000. CONCLUSION: Intracameral cefuroxime administered at the time of surgery significantly reduced the risk for developing endophthalmitis after cataract surgery.
Authors: Frank C Schlichtenbrede; Ulrich H M Spandau; Björn Harder; Jost B Jonas Journal: Graefes Arch Clin Exp Ophthalmol Date: 2009-04-24 Impact factor: 3.117
Authors: Jonathan I Huz; Krishna Mukkamala; Ivelisse Rodriguez Pagan; David Ritterband; Mahendra Shah; Ronald C Gentile; Michael Engelbert Journal: Graefes Arch Clin Exp Ophthalmol Date: 2016-10-19 Impact factor: 3.117