BACKGROUND Cataract surgery in diabetics is more technically challenging due to a number of factors including poor intraoperative pupil dilation and a higher risk of vision threatening complications. This study evaluates the safety and efficacy of an intracameral combination of 2 mydriatics and 1 anesthetic (ICMA, Mydrane) for cataract surgery in patients with well-controlled type-2 diabetes. METHODS Post-hoc subgroup analysis of a phase 3 randomized study, comparing ICMA to a conventional topical regimen. Data were collected from 68 centers in Europe and Algeria. Only well-controlled type-2 diabetics, free of pre-proliferative retinopathy, were included. The results for non-diabetics are also reported. The primary efficacy variable was successful capsulorhexis without additional mydriatic treatment. Postoperative safety included adverse events, endothelial cell density and vision. RESULTS Among 591 randomized patients, 57 (9.6%) had controlled type 2 diabetes [24 (42.1%) in the ICMA Group and 33 (57.9%) in the Topical Group; intention-to-treat (ITT) set]. Among diabetics, capsulorhexis was successfully performed without additional mydriatics in 24 (96.0%; modified-ITT set) patients in the ICMA Group and 26 (89.7%) in the Topical Group. These proportions were similar in non-diabetics. No diabetic patient [1 (0.5%) non-diabetics] in the ICMA Group had a significant decrease in pupil size (≥3 mm) intraoperatively compared to 4 (16.0%; modified-ITT set) diabetics [16 (7.3%) non-diabetics] in the Topical group. Ocular AE among diabetics occurred in 2 (8.0%; Safety set) patients in the ICMA Group and 5 (16.7%) in the Topical Group. Endothelial cell density at 1 month postoperatively was similar between groups in diabetics (P = 0.627) and non-diabetics (P = 0.368). CONCLUSIONS ICMA is effective and can be safely used in patients with well-controlled diabetes, with potential advantages compared to a topical regimen including reduced systemic risk, better corneal integrity and reduced risk of ocular complications. TRIAL REGISTRATION The trial was registered at (reference # NCT02101359) on April 2, 2014.

中文翻译：

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在2型糖尿病患者中，散瞳和麻醉药的标准化前房内联合治疗白内障手术的安全性和有效性。

背景技术由于许多因素，糖尿病患者的白内障手术在技术上更具挑战性，其中包括术中瞳孔散瞳不良和威胁视力的并发症的风险较高。这项研究评估了2种散瞳药和1种麻醉剂（ICMA，Mydrane）的前房内联合治疗2型糖尿病患者白内障手术的安全性和有效性。方法对3期随机研究进行事后亚组分析，将ICMA与常规局部用药方案进行比较。数据来自欧洲和阿尔及利亚的68个中心。仅包括控制良好的2型糖尿病患者，无增生前视网膜病变。还报告了非糖尿病患者的结果。主要疗效变量是成功的撕囊病，无其他散瞳治疗。术后安全性包括不良事件，内皮细胞密度和视野。结果在591名随机分组的患者中，ICMA组中57例（9.6％）患有2型糖尿病[24]（42.1％），局部组33例（57.9％）。意向治疗（ITT）集]。在糖尿病患者中，ICMA组的24例（96.0％；改良ITT组）患者成功进行了撕囊术，而没有局部散瞳，而局部组的26例（89.7％）患者成功进行了。在非糖尿病患者中，这些比例相似。与4名糖尿病患者（16.0％；改良ITT装置）相比，ICMA组中没有糖尿病患者[1（0.5％）非糖尿病患者]术中瞳孔大小（≥3mm）显着减少[16（7.3％）非糖尿病患者-糖尿病患者]。糖尿病患者的眼AE发生在ICMA组的2例（8.0％；安全设定）患者中，局部用药的5例（16.7％）发生。糖尿病组（P = 0.627）与非糖尿病组（P = 0.368）术后1个月的内皮细胞密度相似。结论ICMA是有效的，可以安全地用于控制良好的糖尿病患者，与局部治疗相比具有潜在的优势，包括降低全身风险，改善角膜完整性和降低眼部并发症风险。试验注册该试验于2014年4月2日在（参考号NCT02101359）进行了注册。