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Abstract

We thank Dr Galvis and colleagues for their correspondence. The European Society of Cataract and Refractive Surgeons reported in 2007 the only randomized clinical trial (RCT) evaluating the use of intracameral antibiotics for endophthalmitis prophylaxis during cataract surgery.1ESCRS Endophthalmitis Study GroupProphylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors.J Cataract Refract Surg. 2007; 33 (978-988)Abstract Full Text Full Text PDF Scopus (652) Google Scholar However, this study was limited by the relatively high rates of endophthalmitis in eyes not randomized to receive intracameral cefuroxime, the use of topical levofloxacin, and the use of multiple surgical techniques. The US Food and Drug Administration requires ≥2 consistent trials for good reason. In this case, the totality of evidence is far from clear, with other observational studies reporting very low rates of endophthalmitis without intracameral antibiotics and an unclear risk-benefit ratio associated with these very low rates.2Moshirfar M. Feiz V. Vitale A.T. et al.Endophthalmitis after uncomplicated cataract surgery with the use of fourth-generation fluoroquinolones: a retrospective observational case series.Ophthalmology. 2007; 114 (686-691)Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar Many cataract surgeons, especially in the United States, do not find the results of the European Society of Cataract and Refractive Surgeons study sufficiently compelling to change their practice patterns. We agree with the conclusion of the Cochrane Review,3Gower E.W. Lindsley K. Nanji A.A. et al.Perioperative antibiotics for prevention of acute endophthalmitis after cataract surgery.Cochrane Database Syst Rev. 2013; 7: CD006364PubMed Google Scholar cited by Galvis and colleagues, that it seems unlikely that another major RCT will be conducted in the near future to address this very important topic. Therefore, the practicing cataract surgeon must make clinical decisions based on the best available evidence. What is the best available evidence? Clearly, RCTs represent the highest level of evidence. “Big data” retrospective series and meta-analyses are also beneficial, but largely because of uncontrolled confounding they are not considered to provide the same level of evidence as RCTs. The widespread availability of electronic medical records has led to many observational series. One such recent study, including 3 351 401 surgeries, reported a significant negative association between intracameral cefuroxime and endophthalmitis rates yet concluded, “in the absence of a randomized clinical trial, [these data] cannot prove a direct cause-and-effect relationship.”4Daien V. Papinaud L. Gillies M.C. et al.Effectiveness and safety of an intracameral injection of cefuroxime for the prevention of endophthalmitis after cataract surgery with or without perioperative capsular rupture.JAMA Ophthalmol. 2016; 134 (810-816)Crossref PubMed Scopus (58) Google Scholar Even if the clinical trial results are correct, they do not answer the question of whether the balance of risks and benefits is in favor of the treatment. These important considerations include both medical risks (immediate risk to individuals and risk to the population) and cost of treatment. Intracameral antibiotics are associated with risks to the patient to whom they are administered (including cystoid macular edema, toxic anterior segment syndrome, hemorrhagic occlusive retinal vasculitis, and others) and risks to the population at large by selecting for drug-resistant organisms. Antibiotic stewardship programs seek to reduce the unnecessary and inappropriate use of these agents. In the absence of definitive RCTs, the practicing clinician must consider these issues. “Standard of care” is a legal concept, not a medical one. Standards of care vary by geographic location and change over time. Intracameral antibiotics are not the universal standard of care, even in Europe.5Behndig A. Cochener B. Guell J.L. et al.Endophthalmitis prophylaxis in cataract surgery: overview of current practice patterns in 9 European countries.J Cataract Refract Surg. 2013; 39 (1421-1431)Abstract Full Text Full Text PDF Scopus (87) Google Scholar Evidence-based management emphasizes that clinical decisions should be guided by scientific data, preferably from RCTs. In our opinion, with only 1 RCT, conflicting results from observational studies and no clear risk-benefit ratio, cataract surgeons in the United States should not feel compelled to use intracameral antibiotics. Re: Schwartz et al.: Intracameral antibiotics and cataract surgery: endophthalmitis rates, costs, and stewardship (Ophthalmology 2016;123:1411-1413)OphthalmologyVol. 124Issue 3PreviewWe read with interest the editorial by Schwartz et al1 regarding intracameral antibiotics. It is true that the only randomized clinical trial (RCT) on this topic is the study conducted by the European Society of Cataract and Refractive Surgeons (ESCRS).2 In this very large RCT, which included >16 000 patients, the absence of a prophylactic intracameral cefuroxime injection was associated with a 4.92-fold increase in the risk for postoperative endophthalmitis.2 As Schwartz et al1 highlighted, endophthalmitis rates among patients in the 2 arms not treated with intracameral cefuroxime were relatively high compared with other published series. Full-Text PDF