Hospital Oftalmológico Visão Laser, Avenida Conselheiro Nébias, 355, Santos, São Paulo, 11015-003, Brazil.
Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo (EPM/UNIFESP), São Paulo, Brazil.
BMC Ophthalmol. 2023 Apr 26;23(1):181. doi: 10.1186/s12886-023-02923-3.
This study aims to comparatively evaluate the morphological changes of the cornea after phacoemulsification (PHACO) and femtosecond laser-assisted cataract surgery (FLACS) without intercurrences in patients with type 2 diabetes mellitus.
A total of 95 diabetic patients with moderate cataracts (N2 + and N3+), 47 undergoing PHACO and 48 undergoing FLACS, were selected randomly for the study. Surgeries were performed by a single surgeon between July 2021 and December 2021. Cumulative dissipated energy (CDE) and total balanced saline solution (BSS) data were obtained at the end of each surgery. Changes in corneal endothelial cell density (ECD) and central corneal thickness (CCT) at three months postoperatively were investigated.
After three months, evidence is lacking between groups in the CCT measures; the difference was neither statistically nor clinically relevant. However, for ECD, a significant and clinically significant difference was found; if all patients were treated with laser, the mean ECD would be 423.55 greater (RSE: 86.09; p-value < 0.001; 95% CI: 254.81-592.29) than the ECD potential means of 1656.423 among the conventional group (RSE: 74.90; p-value < 0.001; 95% CI: 1509.62-1803.23).
Diabetic patients under treatment with moderate cataracts may predispose themselves to a more significant loss of endothelial cells after conventional phacoemulsification than femtosecond laser-assisted cataract surgery.
It was registered at The Brazilian Registry of Clinical Trials (ReBEC) with the code RBR-6d8whb5 (UTN code: U1111-1277-6020) on 17/05/2022.
本研究旨在比较评估 2 型糖尿病患者在无并发症的情况下接受超声乳化白内障吸除术(PHACO)和飞秒激光辅助白内障手术(FLACS)后角膜的形态变化。
本研究共纳入 95 例患有中度白内障(N2+和 N3+)的糖尿病患者,其中 47 例行 PHACO,48 例行 FLACS。手术均由同一位医生于 2021 年 7 月至 2021 年 12 月期间进行。在手术结束时,获得累积耗散能量(CDE)和总平衡盐溶液(BSS)数据。术后 3 个月,观察角膜内皮细胞密度(ECD)和中央角膜厚度(CCT)的变化。
术后 3 个月,两组 CCT 测量值无差异;差异既无统计学意义,也无临床意义。然而,对于 ECD,存在显著且有临床意义的差异;如果所有患者均接受激光治疗,则平均 ECD 将增加 423.55(RSE:86.09;p 值<0.001;95%CI:254.81-592.29),而常规组 ECD 潜在均值为 1656.423(RSE:74.90;p 值<0.001;95%CI:1509.62-1803.23)。
接受治疗的 2 型糖尿病伴中度白内障患者在接受常规超声乳化白内障吸除术后,内皮细胞的损失可能比飞秒激光辅助白内障手术更为显著。
本研究于 2022 年 5 月 17 日在巴西临床试验注册中心(ReBEC)注册,注册号为 RBR-6d8whb5(UTN 编号:U1111-1277-6020)。