Győry József F, Németh Gábor, Pesztenlehrer Norbert
Retinaszervíz Kft, Vörösmarty tér 6, Veszprém, 8200, Hungary.
Faculty of Health Sciences, Institute of Clinical Methodology, University of Miskolc, Miskolc-University-city, buildings B3-B4, Miskolc, 3515, Hungary.
BMC Ophthalmol. 2025 May 16;25(1):293. doi: 10.1186/s12886-025-04114-8.
Functional assessment can help identify the true extended depth of focus intraocular lenses (EDOF IOLs) on the market. This study aimed to demonstrate the eligibility of the 877PEY ELON IOL (Medicontur Medical Engineering) as a suitable model for this category and to assess its efficacy in clinical settings.
In total, 38 patients (76 eyes) were enrolled in the study with bilateral implantation of the investigational IOL. For functional classification, a distance-corrected monocular defocus curve was taken 3 months postoperatively. At the 3- and 12-month follow-ups, manifest refraction, monocular and binocular distance, intermediate and near visual acuities, contrast sensitivity, and patient-reported outcomes were recorded.
The defocus range (visual acuity [VA] ≤ 0.2 logMAR) on the distance-corrected monocular normalized defocus curve taken at 3 months was 1.7 D, which falls into the Partial Range of Field Extended (later referred to as PRoF-Ex) category, confirming expectations. The binocular depth of focus (VA ≤ 0.1 logMAR) spanned approximately 0.50 D to -1.50 D, and the functional visual acuity (VA ≤ 0.3 logMAR) spanned approximately 1.00 D to -2.50 D. Monocular CSV-1000 outcomes were above the population's normal ranges. 90.9% of the patients were within ± 0.50 D, and 97.7% were within ± 1.00 D SEQ at the 3-month follow-ups. The outcomes of the VFQ-25 questionnaire demonstrated high scores, and the level of spectacle independence, similar to visual acuity, reflected a strong efficacy in distance and intermediate correction with functional near vision. In terms of photopic phenomena, 90% and 87.5% of patients experienced no-to-moderate rates of glare and halos, respectively. The posterior capsular opacification (PCO) rate was 7.89% at the 12-month follow-up. No adverse events were considered serious.
The 877PEY model demonstrated capability as a PRoF-Ex IOL with remarkable performance. It is safe to use and delivers a high degree of patient satisfaction.
功能评估有助于确定市场上真正的扩展焦深人工晶状体（EDOF IOL）。本研究旨在证明877PEY ELON人工晶状体（Medicontur Medical Engineering）作为该类别的合适模型的适用性，并评估其在临床环境中的疗效。
共有38例患者（76只眼）纳入本研究，双侧植入研究用人工晶状体。为进行功能分类，术后3个月获取距离矫正单眼散焦曲线。在3个月和12个月随访时，记录明显验光、单眼和双眼距离、中距离和近距离视力、对比敏感度以及患者报告的结果。
术后3个月获取的距离矫正单眼标准化散焦曲线上的散焦范围（视力[VA]≤0.2 logMAR）为1.7 D，属于部分视野扩展范围（后称为PRoF-Ex）类别，符合预期。双眼焦深（VA≤0.1 logMAR）约为0.50 D至 -1.50 D，功能视力（VA≤0.3 logMAR）约为1.00 D至 -2.50 D。单眼CSV-1000结果高于人群正常范围。在3个月随访时，90.9%的患者在±0.50 D范围内，97.7%的患者在±1.00 D SEQ范围内。VFQ-25问卷结果显示得分较高，与视力相似的眼镜独立性水平反映出在距离和中距离矫正以及功能性近视力方面具有强大疗效。在明视觉现象方面，分别有90%和87.5%的患者出现无至中度的眩光和光晕发生率。12个月随访时后囊膜混浊（PCO）率为7.89%。未发现严重不良事件。
877PEY模型显示出作为PRoF-Ex人工晶状体的能力，性能卓越。使用安全，患者满意度高。
