U Pleyer1, K Geldsetzer. 1. Universitäts-Augenklinik, Charité Campus Virchow-Klinik, Berlin. Uwe.pleyer@charite.de
Abstract
BACKGROUND: Several studies investigating the antibiotic prophylaxis of acute postoperative endophthalmitis provide very different results concerning the incidence and prophylaxis of this very severe complication of cataract surgery. For a long time the preoperative use of povidione-iodine had been the only procedure with overall acceptance and proven benefit. Following findings in Sweden that supported the advantages of the use of intracameral cefuroxime, the European Society of Cataract and Refractive Surgeons (ESCRS) performed a study to confirm the Swedish results and to lead to a revision of ESCRS guidelines. PATIENTS/ MATERIAL AND METHODS: In a randomised, partially masked and placebo-controlled study 16,211 patients undergoing phacoemulsification cataract surgery were included. 25 ophthalmological units in 9 European countries took part in this study. The study consists of a 2 x 2 factorial design, dividing patients into 4 treatment groups. Two out of the 4 groups were treated with 1 mg intracameral cefuroxime (in 0.1 mL isotonic NaCl solution). In parallel, two groups (one treated with cefuroxime, one untreated) received topical levofloxacin 0.5% in a standard regimen. If clinical signs like pain or loss of vision indicated a postoperative endophthalmitis, suspicious results were confirmed by culture, Gram stain and PCR. In a follow-on study, Sundelin (Sweden) and colleagues included 30 patients who receivedtopically-applied levofloxacin 0.5% following the ESCRS dosing scheme, in addition to intracameral administration of cefuroxime. Aqueous humour samples were taken at the end of surgery and at a second time point postoperatively. The levofloxacin concentration was measured by HPLC. The median maximal concentration (Cmax) was compared with the MIC90-values of relevant bacterial isolates. RESULTS:29 patients developed a postoperative endophthalmitis, of whom 20 were classified as having a proven infectious cause. The absence of a prophylactic intracameral cefuroxime administration at 1 mg in 0.1 mL isotonic NaCl was associated with a 4.92-fold increase in the risk of postoperative endophthalmitis (95% CI 1.87-12.9). A clear corneal incision (CCI) or the use of silicon based IOL optic material accounted as additional risk factors for postoperative endophthalmitis. While the use of CCI was associated with a 5.88-fold higher risk of infection compared to STI (scleral tunnel incision), the implantation of silicon based IOL was associated with a 3.13-fold higher risk. Intraoperative complications were also associated with a higher risk of postoperative endophthalmitis (4.95-fold higher risk). CONCLUSION: Intracameral injection of cefuroxime reduces the risk of postoperative infectious endophthalmitis following phacoemulsification cataract surgery. Additional risk factors are the use of CCI and silicon based IOL implants.
RCT Entities:
BACKGROUND: Several studies investigating the antibiotic prophylaxis of acute postoperative endophthalmitis provide very different results concerning the incidence and prophylaxis of this very severe complication of cataract surgery. For a long time the preoperative use of povidione-iodine had been the only procedure with overall acceptance and proven benefit. Following findings in Sweden that supported the advantages of the use of intracameral cefuroxime, the European Society of Cataract and Refractive Surgeons (ESCRS) performed a study to confirm the Swedish results and to lead to a revision of ESCRS guidelines. PATIENTS/ MATERIAL AND METHODS: In a randomised, partially masked and placebo-controlled study 16,211 patients undergoing phacoemulsification cataract surgery were included. 25 ophthalmological units in 9 European countries took part in this study. The study consists of a 2 x 2 factorial design, dividing patients into 4 treatment groups. Two out of the 4 groups were treated with 1 mg intracameral cefuroxime (in 0.1 mL isotonic NaCl solution). In parallel, two groups (one treated with cefuroxime, one untreated) received topical levofloxacin 0.5% in a standard regimen. If clinical signs like pain or loss of vision indicated a postoperative endophthalmitis, suspicious results were confirmed by culture, Gram stain and PCR. In a follow-on study, Sundelin (Sweden) and colleagues included 30 patients who received topically-applied levofloxacin 0.5% following the ESCRS dosing scheme, in addition to intracameral administration of cefuroxime. Aqueous humour samples were taken at the end of surgery and at a second time point postoperatively. The levofloxacin concentration was measured by HPLC. The median maximal concentration (Cmax) was compared with the MIC90-values of relevant bacterial isolates. RESULTS: 29 patients developed a postoperative endophthalmitis, of whom 20 were classified as having a proven infectious cause. The absence of a prophylactic intracameral cefuroxime administration at 1 mg in 0.1 mL isotonic NaCl was associated with a 4.92-fold increase in the risk of postoperative endophthalmitis (95% CI 1.87-12.9). A clear corneal incision (CCI) or the use of silicon based IOL optic material accounted as additional risk factors for postoperative endophthalmitis. While the use of CCI was associated with a 5.88-fold higher risk of infection compared to STI (scleral tunnel incision), the implantation of silicon based IOL was associated with a 3.13-fold higher risk. Intraoperative complications were also associated with a higher risk of postoperative endophthalmitis (4.95-fold higher risk). CONCLUSION: Intracameral injection of cefuroxime reduces the risk of postoperative infectious endophthalmitis following phacoemulsification cataract surgery. Additional risk factors are the use of CCI and silicon based IOL implants.