ESCRS study of prophylaxis of @entity86 after XXXX surgery: Preliminary report of principal results from a European multicenter study.

@entity2261 @entity1 @entity233 @entity231 @entity281 @entity86 @entity3225 @entity800
PURPOSE: To report results in the European Society of Cataract _ Refractive Surgeons (ESCRS) multicenter study of the prophylaxis of @entity3225 after @entity231 surgery. SETTING: Twenty-four ophthalmology units and eye clinics in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, @entity233 , 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 @entity2261 injection and/or perioperative @entity800 eyedrops on the incidence of @entity3225 after phacoemulsification @entity231 surgery began in September 2003 and was terminated early in January 2006. The study used random allocation of @entity1 in a 2 x 2 factorial design. RESULTS: By the end of 2005, complete follow-up records had been received for 13 698 study @entity1 . Such a clear beneficial effect from the use of intracameral @entity2261 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 @entity3225 are considered, the incidence rate observed in those treatment groups not receiving @entity2261 prophylaxis (23 cases in 6862 @entity1 ) 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 @entity1 ). If only cases proved to be due to @entity281 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 @entity2261 . Although the use of perioperative @entity800 eyedrops as prophylaxis was also associated with a reduction in the observed incidence rate of @entity86 , this effect was smaller and was not statistically significant, whether total reported cases or only cases proven to be due to @entity281 are used in calculating the rates. As not all follow-up procedures are complete, it is possible that further cases of @entity3225 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 @entity1 will increase the total number in the study to approximately 16,000. CONCLUSION: Intracameral @entity2261 administered at the time of surgery significantly reduced the risk for developing @entity3225 after @entity231 surgery.
