Albo Camila, Nasser Taj, Szynkarski David Thomas, Nguyen Ngoc, Mueller Brett, Libfraind Lauren, Parkhurst Gregory
Department of Ophthalmology, University of Texas Health San Antonio, San Antonio, TX, USA.
Department of Ophthalmology, Parkhurst NuVision, San Antonio, TX, USA.
Clin Ophthalmol. 2024 Jan 9;18:69-78. doi: 10.2147/OPTH.S440578. eCollection 2024.
We evaluate visual outcomes in patients with EVO/EVO+™ (posterior chamber phakic intraocular lens with a central port) within approved United States (US) age and refractive range indications.
This single-center retrospective study evaluated one-month, single-center postoperative data for 225 eyes meeting inclusion criteria and undergoing EVO/EVO+ implantation from April to October 2022. Data included lens size (mm), lens power (diopters of spherical and cylindrical power), preoperative best corrected visual acuity, preoperative spherical equivalent from manifest refraction, achieved postoperative uncorrected visual acuity, postoperative refraction, intraocular pressure (mmHg), and adverse events.
A total of 225 eyes underwent EVO/EVO+ Implantable Collamer Lens (ICL) implantation from April to October 2022, with 51.5% receiving toric lenses. The most common ICL size was 12.6mm (56.4%), followed by 13.2mm (27.5%), 12.1mm (15.1%), and 13.7mm (0.9%). Among patients with preoperative BCVA of 20/20 or better (149 eyes), 95.2% achieved postoperative UCVA of 20/20 or better, and 99.3% achieved UCVA of 20/25 or better at postoperative month one. About 75% of eyes were within a spherical equivalent target of ±0.50 D and 94% within ±1.00 D. Toric ICLs were implanted in 116 eyes (51.8%). Of these, anticipated residual cylinder >1 diopter was seen in 21 eyes (18.1%) resulting in three rotations, three explants, and three laser vision correction (LVC) enhancements. The postoperative adjustment rate (including rotations, exchanges, and LVC enhancement) was minimal (4.8%). Incidence of major adverse events was 0%.
Our study, the largest US single-center analysis of EVO/EVO+ ICL implantation, demonstrates strong early results and infrequent adverse events, supporting ICL safety and effectiveness. High predictability and favorable visual outcomes, including 20/20 or better, highlight the reliability of this technology. Despite study limitations, our findings underscore this technology's effectiveness. Future research should refine patient criteria and assess long-term outcomes in this evolving landscape.
我们评估了在美国批准的年龄和屈光范围内，植入EVO/EVO+™（带中央端口的后房型有晶体眼人工晶状体）的患者的视觉效果。
这项单中心回顾性研究评估了2022年4月至10月期间225只符合纳入标准并接受EVO/EVO+植入的眼睛的单中心术后1个月数据。数据包括晶状体尺寸（毫米）、晶状体度数（球镜和柱镜度数）、术前最佳矫正视力、根据显然验光得出的术前等效球镜度数、术后裸眼视力、术后验光、眼压（毫米汞柱）以及不良事件。
2022年4月至10月期间，共有225只眼睛接受了EVO/EVO+可植入式胶原晶状体（ICL）植入，其中51.5%的患者接受了散光晶状体。最常见的ICL尺寸是12.6毫米（56.4%），其次是13.2毫米（27.5%）、12.1毫米（15.1%）和13.7毫米（0.9%）。在术前最佳矫正视力为20/20或更好的患者（149只眼睛）中，95.2%的患者术后裸眼视力达到20/20或更好，99.3%的患者在术后1个月时裸眼视力达到20/25或更好。约75%的眼睛等效球镜度数在±0.50 D范围内，94%在±1.00 D范围内。116只眼睛（51.8%）植入了散光ICL。其中，21只眼睛（18.1%）出现预期残余散光>1屈光度，导致3次旋转、3次取出和3次激光视力矫正（LVC）增强。术后调整率（包括旋转、更换和LVC增强）极低（4.8%）。主要不良事件发生率为0%。
我们的研究是美国对EVO/EVO+ ICL植入进行的最大规模单中心分析，显示出良好的早期结果且不良事件罕见，支持了ICL的安全性和有效性。高可预测性和良好的视觉效果，包括20/20或更好的视力，突出了这项技术的可靠性。尽管研究存在局限性，但我们的发现强调了这项技术的有效性。未来的研究应完善患者标准，并评估这一不断发展领域的长期结果。
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