Ferrer-Alapont Lorena, Bernal-Morales Carolina, Navarro Manuel J, Ruiz-Casas Diego, García-Arumí Claudia, Cubero-Parra Juan Manuel, Dabad-Moreno Jose Vicente, Velázquez-Villoria Daniel, Marticorena Joaquín, Zarco-Bosquet Julián, Armada-Maresca Félix, Irigoyen Cristina, Santamaría-Álvarez Juan-Francisco, Carnota-Méndez Pablo, Sánchez-Santos Idaira, Olivier-Pascual Nuria, Ascaso Francisco Javier, Zarranz-Ventura Javier
Hospital Clínic of Barcelona, University of Barcelona, 08036 Barcelona, Spain.
August Pi i Sunyer Biomedical Research Institute (IDIBAPS), 08036 Barcelona, Spain.
J Clin Med. 2025 Jun 4;14(11):3963. doi: 10.3390/jcm14113963.
The aim of this study was to evaluate the clinical outcomes of sutureless scleral-fixated (SSF) Soleko Fil Carlevale intraocular lens (SC-IOL) implants associated with pars plana vitrectomy (PPV) in patients with aphakia secondary to complicated cataract surgery or IOL luxation nationwide. A multicenter, national, retrospective study of 268 eyes (268 patients) which underwent simultaneous PPV and SC-IOL implantation was conducted. Demographics; ocular data; pre-surgical, surgical and post-surgical details; and refractive results were collected. Intra- and postoperative complications and management details were described. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central retinal thickness (CRT) were collected at 1 week and at 1, 3, 6 and 12 months post-surgery. Kaplan-Meier curves were constructed to assess the cumulative probability of postoperative BCVA, IOP levels, macular edema (ME) and corneal decompensation. The cumulative probability of final VA ≤ 0.3 logMAR was 64.4% at 12 months follow-up. The probability of IOP > 21, ≥25 and ≥30 mmHg was 29.8%, 16.9% and 10.1%, respectively, and the cumulative probability of IOP-lowering treatment was 42.3% at 12 months. Glaucoma surgery was required in 3.7% of the eyes (10/268). The cumulative probability of postoperative ME development was 26.6% at 12 months, managed with topical treatment alone (73.5%) and intravitreal injections (26.5%). Corneal transplantation was required in 3.7% of the eyes (10/268). Sutureless scleral-fixated SC-IOL is an adequate therapeutic alternative in the management of aphakia with good visual results and an acceptable safety profile in routine clinical care. Longer-term studies are needed to evaluate its results and complications compared to other therapeutic alternatives.
本研究的目的是在全国范围内评估无缝线巩膜固定（SSF）Soleko Fil Carlevale人工晶状体（SC-IOL）植入联合玻璃体切除术（PPV）治疗复杂白内障手术或人工晶状体脱位继发无晶状体眼患者的临床结局。对268只眼（268例患者）同时进行PPV和SC-IOL植入的多中心、全国性回顾性研究。收集了人口统计学数据、眼部数据、术前、手术中和术后细节以及屈光结果。描述了术中及术后并发症和处理细节。在术后1周以及术后1、3、6和12个月收集最佳矫正视力（BCVA）、眼压（IOP）和中心视网膜厚度（CRT）。构建Kaplan-Meier曲线以评估术后BCVA、IOP水平、黄斑水肿（ME）和角膜失代偿的累积概率。随访12个月时，最终视力≤0.3 logMAR的累积概率为64.4%。IOP>21、≥25和≥30 mmHg的概率分别为29.8%、16.9%和10.1%，12个月时降低IOP治疗的累积概率为42.3%。3.7%的眼（10/268）需要进行青光眼手术。术后12个月ME发生的累积概率为26.6%，仅通过局部治疗（73.5%）和玻璃体内注射（26.5%）进行处理。3.7%的眼（10/268）需要进行角膜移植。无缝线巩膜固定SC-IOL是治疗无晶状体眼的一种合适的治疗选择，在常规临床护理中视觉效果良好且安全性可接受。与其他治疗选择相比，需要进行长期研究以评估其结果和并发症。
