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

重要性 选择与白内障手术同时进行的抗炎预防对于患者安全和手术的成功结果很重要，但选择哪种治疗方案存在争议。

目的 确定与 NSAID 单药治疗和 Tenon 下胶囊库相比，泼尼松龙和非甾体抗炎药 (NSAID) 滴眼液的组合在预防单纯性白内障手术后中央黄斑厚度增加（中央亚区厚度 [CST]）方面是否具有优势。无滴眼手术），并测试术前开始滴眼治疗是否优于在手术当天开始。

设计、设置和参与者 这项由研究人员驱动的单中心随机临床试验与蒙面统计分析在 2018 年 2 月 1 日至 2019 年 8 月 15 日期间在丹麦格洛斯特鲁普的 Rigshospitalet Glostrup 眼科招募了患者。升级于 2019 年 12 月 18 日完成。参与者包括由经验丰富的外科医生（每位参与者 1 只眼睛）接受老年性白内障超声乳化术的低风险患者。数据分析时间为 2020 年 2 月 17 日至 6 月 15 日。

干预 计划切除白内障的参与者被随机分配到 5 种抗炎预防方案中的一种：滴眼液联合 1% 的泼尼松龙和 0.5% 的酮咯酸氨丁三醇，有或没有术前开始（术前泼尼松龙加非甾体抗炎药 [对照] 和术后泼尼松龙加非甾体抗炎药组），酮咯酸单药治疗（术前和术后非甾体抗炎药组），或磷酸地塞米松亚特农库（亚特农组）。每天滴眼药3次，直至术后3周。

主要结果和措施 CST 术后 3 个月。

结果 共有 470 名参与者（平均 [SD] 年龄，72.2 [7.0] 岁；290 名女性 [61.7%]），每组 94 名参与者被纳入分析。术后 3 个月，术前泼尼松龙联合 NSAID 组的平均 CST 为 250.7（95% CI，247.6-253.7）μm，术后泼尼松龙联合 NSAID 组为 250.7（95% CI，247.8-253.7）μm，251.3（95 % CI，术前 NSAID 组为 248.2-254.4) μm，术后 NSAID 组为 249.2 (95% CI，246.2-252.3) μm，Tenon 下组为 255.2 (95% CI，252.0-258.3) μm。与对照组相比，CST 或视力没有显着差异，术前和术后组之间也没有差异，但 sub-Tenon 组的 83 名参与者中有 47 名（56.6%）需要额外的抗炎治疗。

结 _治疗。术前 3 天开始预防并不优于在手术当天开始。非复杂性白内障手术可能首选非甾体抗炎药单药治疗。

试验注册 ClinicalTrials.gov 标识符：NCT03383328