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Abstract

The ESCRS PREMED study is a randomized controlled clinical trial (RCT), the aim of which was to identify the optimum strategy to prevent CME after cataract surgery. This study was not designed to investigate the pharmacologic action of corticosteroids and NSAIDs. The dose and frequency of topical dexamethasone administration were chosen based on clinical practice as well as the results in previous RCTs. Corticosteroid eyedrops were included in the standard of care in 9 of 12 study centers participating in the PREMED study; the vast majority of those centers used dexamethasone 4 times daily during the immediate postoperative period. Although prednisolone eyedrops result in the highest aqueous corticosteroid levels, dexamethasone is a more potent antiinflammatory drug.1 Moreover, previous metaanalyses2 have shown that potent and weaker corticosteroids are less effective than NSAIDs in the prevention of postoperative inflammation and CME. The dosage and frequency of dexamethasone and bromfenac administration were equal in the single treatment and combination treatment groups. The corneal safety profile of bromfenac twice daily for 2 days preoperatively and 2 weeks postoperatively was good. As shown in Appendix 5 of the PREMED study report 1, there were no significant differences in the incidence of corneal adverse events between treatment groups. The PREMED study showed that the odds of developing clinically significant macular edema within 3 months postoperatively were significantly higher in patients using dexamethasone only compared with a combination treatment of bromfenac (odds ratio, 3.70; P = .023). Based on these data, the number needed to treat is 27. This means that compared with patients using dexamethasone only, 27 patients must be treated with topical dexamethasone and bromfenac to prevent 1 case of clinically significant macular edema. The number needed to treat of 1:1500, as stated by Fanton et al.,3 is based on personal routine instead of scientific data. Ophthalmologists who prefer using single-drug treatment after cataract surgery should consider using bromfenac only because it reduces the incidence of clinically significant macular edema compared with dexamethasone. Furthermore, less frequent drug dosing will reduce the burden for homecare services, which are frequently involved in postoperative care. We are well aware of the varying prices of NSAID eyedrops, which are markedly more expensive in the U.S.4 The cost-effectiveness of topical dexamethasone and/or bromfenac will be described in a PREMED study follow-up report. Preliminary results show that dexamethasone is less likely cost-effective than bromfenac or a combination treatment.A It is known that most cases of CME develop approximately 6 weeks postoperatively. It appears unlikely that a great number of patients developed clinically significant macular edema after the final study visit, and we do not expect these cases to significantly change the conclusions of the PREMED study. Finally, there are many reasons why dropless cataract surgery is a major current focus in clinical research. Dropless cataract surgery can involve intraocular or periocular injection of corticosteroids and/or NSAIDs, such as Omidria. To our knowledge, no well-designed studies comparing the current practice of topical corticosteroids and NSAIDs versus dropless use of corticosteroids and/or NSAIDs are yet available.