Pseudophakic Cystoid Macular Oedema (PCME) Prevention in Patients with Non-Proliferative Diabetic Retinopathy (NPDR)-Randomized Controlled Trial.

Background and Objectives: The purpose of this study was to compare the effect of topical bromfenac and dexamethasone on the intraocular concentration of interleukin 6 (IL-6) and incidence of pseudophakic cystoid macular oedema (PCME) after cataract surgery in patients with non-proliferative diabetic retinopathy (NPDR). Materials and Methods: Ninety eyes of patients with mild-to-moderate NPDR that underwent phacoemulsification cataract surgery were divided into three groups. A detailed description of the clinical study protocol is described later in paper. In short, Group 1 received topical bromfenac (0.9 mg/mL), Group 2 dexamethasone (1 mg/mL), and Group 3 placebo, both preoperatively and postoperatively. Additionally, all patients received combined topical steroid and antibiotic drops (dexamethasone, neomycin and polymyxin B) 3 weeks postoperatively. On the day of the surgery, aqueous humour samples (0.1-0.2 mL) were obtained and IL-6 concentrations were analysed. Central foveal subfield thickness (CFT) measured using spectral-domain optical coherence tomography (SD-OCT) was analysed preoperatively and postoperatively. Results: There was no significant difference in IL-6 concentrations between groups. Postoperative CFT was significantly lower in the dexamethasone group compared to the placebo group. In addition, the correlation between IL-6 and CFT was statistically significant in the dexamethasone group. No patient developed PCME in any of the three groups. No adverse events were reported during the study. Conclusion: Topical bromfenac and dexamethasone have no significant effect on intraocular IL-6 concentration in patients with NPDR. Topical bromfenac is not more effective than topical dexamethasone in reducing postoperative CFT in patients with NPDR.