Nuijts Rudy M M A, Cochener-Lamard Béatrice, Szaflik Jacek P, Mencucci Rita, Chiambaretta Frédéric, Behndig Anders
University Eye Clinic, Maastricht University Medical Center, Maastricht, the Netherlands.
Ophthalmology Department, CHU Morvan, University Hospital of Brest, and University of Bretagne Occidentale (UBO), Brest, France.
Clin Ophthalmol. 2024 Apr 25;18:1103-1115. doi: 10.2147/OPTH.S453257. eCollection 2024.
To compare the safety of a standardized, commercially available intracameral combination of mydriatics and anesthetic (ICMA) with a reference topical mydriatic regimen for cataract surgery.
The safety results from two international, randomized, controlled clinical studies were combined to compare ICMA at the beginning of cataract surgery (ICMA group) to the reference topical mydriatic regimen (reference group). Data were collected on ocular and systemic adverse events, corneal and anterior chamber examination, endothelial cell density, retinal thickness and visual acuity. Analysis was performed on a pooled safety set from both studies, preoperatively and up to 1 month postoperatively.
342 patients received ICMA and 318 the reference topical regimen. Ocular adverse events were reported in 17.0% of patients in the ICMA group and 18.6% in the reference group. No difference was shown between groups in endothelial cell density (2208 ± 498 cells/mm for ICMA group versus 2241 ± 513 cells/mm for the reference group; ) and retinal thickness (change from baseline less than 50 µm in 94.7% versus 95.0% of patients, respectively) at 1 month postoperatively. At 1-day post-surgery, less patients in the ICMA group had moderate or severe (Grades 2 and 3) superficial punctate corneal staining (3.9% versus 7.0% for the reference group; ). Postoperatively, some ocular symptoms were also less frequently reported in the ICMA group. Best-corrected visual acuity increased in 96.0% of patients in the ICMA group and 95.8% in the reference group at 1 month.
ICMA injection at the beginning of cataract surgery was demonstrated to be safe and may also provide perioperative and postoperative advantages over the standard topical mydriatic regimen.
比较标准化的市售散瞳药与麻醉剂眼内联合用药（ICMA）和用于白内障手术的对照局部散瞳方案的安全性。
两项国际随机对照临床研究的安全性结果相结合，以比较白内障手术开始时的ICMA（ICMA组）与对照局部散瞳方案（对照组）。收集有关眼部和全身不良事件、角膜和前房检查、内皮细胞密度、视网膜厚度和视力的数据。对两项研究的汇总安全数据集进行术前及术后1个月的分析。
342例患者接受了ICMA，318例接受了对照局部用药方案。ICMA组17.0%的患者报告了眼部不良事件，对照组为18.6%。术后1个月时，两组在内皮细胞密度（ICMA组为2208±498个细胞/mm²，对照组为2241±513个细胞/mm²）和视网膜厚度（分别有94.7%和95.0%的患者视网膜厚度较基线变化小于50μm）方面无差异。术后1天，ICMA组中度或重度（2级和3级）浅层点状角膜染色的患者较少（对照组为7.0%，ICMA组为3.9%）。术后，ICMA组一些眼部症状的报告频率也较低。1个月时，ICMA组96.0%的患者最佳矫正视力提高，对照组为95.8%。
白内障手术开始时注射ICMA被证明是安全的，并且与标准局部散瞳方案相比，在围手术期和术后可能也具有优势。
