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Key Points Question Is a combination of corticosteroid and nonsteroidal anti-inflammatory drug (NSAID) eye drops superior to NSAID eye drops alone or dropless surgery with a sub-Tenon dexamethasone depot in controlling postoperative central macular thickening after uncomplicated cataract surgery? Findings In this randomized clinical trial with 470 participants, no differences in central subfield thickness or visual acuity across treatment arms were identified, although approximately half of the group given the sub-Tenon depot received additional anti-inflammatory treatment. Meaning Therapy with NSAID plus corticosteroid eye drops was not superior to NSAID monotherapy or sub-Tenon depot for postoperative central macular thickening after uncomplicated cataract surgery., This randomized clinical trial assesses whether corticosteroid plus nonsteroidal anti-inflammatory drug (NSAID) eye drops were superior in preventing macular thickening compared with NSAID monotherapy and/or a sub-Tenon dexamethasone depot among patients undergoing uncomplicated cataract surgery., Importance The choice of anti-inflammatory prophylaxis parallel to cataract surgery is important for patient safety and successful outcome of surgery, but which regimen to choose is contested. Objectives To determine whether a combination of prednisolone and nonsteroidal anti-inflammatory drug (NSAID) eye drops was superior in preventing increased central macular thickness (central subfield thickness [CST]) after uncomplicated cataract surgery compared with NSAID monotherapy and sub-Tenon capsule depot (dropless surgery), and to test whether preoperative initiation of eye drop treatment was superior to initiation on the day of surgery. Design, Setting, and Participants This investigator-driven, single-center, randomized clinical trial with masked statistical analyses enrolled patients at the Department of Ophthalmology, Rigshospitalet Glostrup, Glostrup, Denmark, from February 1, 2018, to August 15, 2019. Follow-up was completed December 18, 2019. Participants included low-risk patients undergoing phacoemulsification for age-related cataract by an experienced surgeon (1 eye per participant). Data were analyzed from February 17 to June 15, 2020. Interventions Participants scheduled for cataract removal were randomized to 1 of 5 anti-inflammatory prophylactic regimens: eye drops with a combination of prednisolone, 1%, and ketorolac tromethamine, 0.5%, with or without preoperative initiation (preoperative prednisolone plus NSAID [control] and postoperative prednisolone plus NSAID groups), ketorolac monotherapy with or without preoperative initiation (preoperative and postoperative NSAID groups), or sub-Tenon depot of dexamethasone phosphate (sub-Tenon group). Eye drops were administered 3 times per day until 3 weeks postoperatively. Main Outcomes and Measures CST 3 months postoperatively. Results A total of 470 participants (mean [SD] age, 72.2 [7.0] years; 290 women [61.7%]) with 94 participants in each group were included in the analysis. Three months after surgery, the mean CST was 250.7 (95% CI, 247.6-253.7) μm in the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) μm in the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) μm in the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) μm in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) μm in the sub-Tenon group. There were no significant differences in CST or visual acuity compared with control and no differences between preoperative and postoperative groups, but 47 of 83 participants (56.6%) in the sub-Tenon group needed additional anti-inflammatory treatment. Conclusions and Relevance No differences in CST or visual acuity were detected between the combination of prednisolone and NSAID eye drops vs NSAID monotherapy or sub-Tenon dexamethasone depot, although more than one-half of patients in the sub-Tenon arm received additional anti-inflammatory treatment. Initiating prophylaxis 3 days preoperatively was not superior to initiation on the day of surgery. Monotherapy with NSAIDs may be preferred in uncomplicated cataract surgery. Trial Registration ClinicalTrials.gov Identifier: NCT03383328

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