J Refract Surg. 2021 Feb 1;37(2):126-132. doi: 10.3928/1081597X-20201207-02.
To evaluate the visual outcomes and possible complications of a new foldable sutureless scleral fixation intraocular lens (SSF-IOL), the Carlevale IOL (Soleko).
The SSF-IOL, which has two T-shaped self-blocking plugs on each haptic, was inserted into the posterior chamber. Both haptics was grabbed through two sclerotomies and the two short arms were blocked under the scleral flap, without any suture. A complete clinical evaluation was done preoperatively and at 3, 6, and 12 months postoperatively.
A total of 54 eyes of 50 consecutive patients were retrospectively analyzed. The mean corrected distance visual acuity was 0.93 ± 0.61 logMAR preoperatively and improved to 0.42 ± 0.34 logMAR at 3 months, 0.42 ± 0.37 logMAR at 6 months, and 0.38 ± 0.38 logMAR at 12 months postoperatively (all P < .0001). The mean corneal endothelial cell density decreased from 1,725.37 ± 528.06 to 1,612.81 ± 522.91 cells/mm at 12 months postoperatively (P < .0001). The mean IOL tilt value was 3.1 ± 1.1° at 12 months postoperatively. The authors observed 6 cases (11.1%) of intraoperative rupture of the IOL haptics, 4 cases (7.4%) of early hyphema, 4 cases (7.4%) of macular cystoid edema, 2 cases (3.7%) of haptic exposure under the conjunctiva, and 1 (1.8%) late retinal detachment.
This newly introduced surgical technique provided promising results regarding efficacy and safety. Complications occurred in a few cases and were successfully managed. The Carlevale IOL seems to be a surgical solution combining the advantages of an easy and minimally invasive implantation with a good functional recovery with minimal complications. [J Refract Surg. 2021;37(2):126-132.].
评估新型可折叠免缝线巩膜固定型人工晶状体（SSF-IOL）——卡莱瓦利（Carlevale）IOL 的视力结果和潜在并发症。
将具有两个 T 型自阻塞塞的 SSF-IOL 插入后房。通过两个巩膜切口抓取两个襻，并将两个短臂阻塞在巩膜瓣下，无需任何缝线。术前和术后 3、6 和 12 个月进行全面临床评估。
回顾性分析 50 例（54 只眼）连续患者。平均矫正远视力从术前的 0.93 ± 0.61 logMAR 提高到术后 3 个月的 0.42 ± 0.34 logMAR、术后 6 个月的 0.42 ± 0.37 logMAR 和术后 12 个月的 0.38 ± 0.38 logMAR（均 P <.0001）。角膜内皮细胞密度从术后 12 个月的 1,725.37 ± 528.06 降至 1,612.81 ± 522.91 个/平方毫米（P <.0001）。术后 12 个月时平均 IOL 倾斜值为 3.1 ± 1.1°。作者观察到 6 例（11.1%）术中 IOL 襻断裂、4 例（7.4%）早期前房积血、4 例（7.4%）黄斑囊样水肿、2 例（3.7%）结膜下 IOL 暴露和 1 例（1.8%）迟发性视网膜脱离。
这种新引入的手术技术在疗效和安全性方面提供了有前景的结果。少数病例发生并发症，并成功处理。卡莱瓦利 IOL 似乎是一种手术解决方案，结合了易于操作和微创植入的优势，具有良好的功能恢复和最小的并发症。
