International Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.
Augen-MVZ Landshut, Landshut, Germany.
PLoS One. 2021 Sep 2;16(9):e0256985. doi: 10.1371/journal.pone.0256985. eCollection 2021.
This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.
这项多中心、开放性研究旨在确定高附加分段折射双焦点人工晶状体（IOL）在晚期非活动期年龄相关性黄斑变性（AMD）中的安全性和功能结果。20 名患者的 20 只眼入组并随访至干预后 12 个月。患者接受白内障手术，植入 LS-313 MF80 分段折射双焦点人工晶状体，附加+8.0D（Teleon Surgical Vertriebs GmbH，柏林，德国）。主要观察指标为远距矫正近视力（DCNVA）和手术和术后并发症确定的安全性。次要结果包括远距矫正视力（CDVA）、未矫正远视力（UDVA）、未矫正近视力（UNVA）、阅读报纸所需的放大倍数、最佳阅读距离、速度和性能（logRAD）以及患者满意度。术后 6 个月时，DCNVA 从 0.95（±0.19）logMAR 提高至 0.74（±0.35）logMAR，P<0.05。CDVA 从 0.70（±0.23）logMAR 提高至 0.59（±0.30）logMAR，UDVA 从 0.94（±0.25）logMAR 提高至 0.69（±0.34）logMAR，UNVA 从 1.08（±0.19）logMAR 提高至 0.87（±0.43）logMAR。平均放大需求从 2.9 倍降至 2.3 倍，最佳阅读距离从 23cm 降至 20cm。任何手术均未发生术中并发症。1 例患者在 6-12 个月时 CDVA 丧失>2 行，另 1 例因畏光和 CDVA 下降而将研究性 IOL 更换为单焦点 IOL。植入附加+8.0D 的分段折射双焦点 IOL 可改善晚期 AMD 患者的近距和远距视力，且具有令人满意的安全性。
