Dataset_Optical and Clinical Outcomes of an Isofocal Intraocular Lens vs. a Monofocal Standard Lens

Dataset used in the work "Optical and Clinical Outcomes of an Isofocal Intraocular Lens vs. a Monofocal Standard Lens" (Pérez-Sanz L, Gonzalez-Fernandez V, Gómez-Pedrero JA, Albarrán-Diego C, García-Montero M, Garzón N. Optical and Clinical Outcomes of an Isofocal Intraocular Lens vs. a Monofocal Standard Lens. Life 2023, 13, 2001. https://doi.org/10.3390/life13102001) The aim of the study is to evaluate the results obtained on the optical bench and clinically with an isofocal lens (ISOPure, BVI medical, Belgium) to compare them to a standard monofocal one (MicroPure, BVI medical, Belgium). To do so, we have combined laboratory investigation and a prospective, comparative, and randomized clinical study. First, we have measured the wavefront of the two models studied using a NIMO TR1504 (Lambda-X, Belgium) deflectometer for three nominal powers: +10.00, +20.00 and +30.00 D. In the randomized study with 48 patients, half of them implanted with ISOPure and the other with MicroPure, we have measured visual acuities and contrast sensitivity under photopic and mesopic conditions. The optical bench results show that the isofocal lens presented higher power than the monofocal one, at the lens center, due to the spherical aberration (coefficients Z(4,0), Z(6,0) and Z(8,0)) induced by the greater asphericity of its design. The addition obtained depended on the nominal power, from +1.00 to +1.50 D. The results of the clinical study showed that the ISOPure lens presented better visual outcomes, which were statistically significant, at intermediate distance compared to the MicroPure lens (p-values of 0.014 and 0.022 for 80 and 60 cm, respectively) without decreasing the contrast sensitivity. Clinical outcomes were not affected by pupillary size. In conclusion, due to the increase in power at the lens center due to its highly aspherical design, the isofocal lens evaluated showed better intermediate vision than the monofocal one.本数据集来源于学术论文《等焦人工晶状体与单焦点标准人工晶状体的光学及临床疗效》（Pérez-Sanz L, Gonzalez-Fernandez V, Gómez-Pedrero JA, Albarrán-Diego C, García-Montero M, Garzón N. Optical and Clinical Outcomes of an Isofocal Intraocular Lens vs. a Monofocal Standard Lens. Life 2023, 13, 2001. https://doi.org/10.3390/life13102001）。 本研究旨在评估等焦人工晶状体（isofocal intraocular lens，ISOPure，比利时BVI医疗公司）在光学平台及临床应用中的效果，并与标准单焦点人工晶状体（monofocal intraocular lens，MicroPure，比利时BVI医疗公司）进行对照比较。为此，本研究结合了实验室检测与一项前瞻性、对照随机临床试验。 首先，研究团队使用NIMO TR1504（比利时Lambda-X公司）偏折计（deflectometer），针对+10.00、+20.00、+30.00 D三种标称屈光度，对两种受试晶状体的波前像差（wavefront aberration）进行了测量。 在纳入48名受试者的随机对照临床试验中，半数患者植入ISOPure晶状体，其余患者植入MicroPure晶状体。研究团队分别在明视（photopic）与中间视（mesopic）条件下，测量了受试者的视力与对比敏感度。 光学平台检测结果显示，由于等焦人工晶状体的非球面设计程度更高，其诱导的球差（spherical aberration，泽尼克系数Z(4,0)、Z(6,0)及Z(8,0)）使得晶状体中心的实际屈光度高于单焦点人工晶状体，该屈光增量随标称屈光度变化，范围为+1.00至+1.50 D。 临床试验结果表明，相较于MicroPure晶状体，ISOPure晶状体在中距离视力方面表现更优，且该差异具有统计学显著性（80cm与60cm测试距离对应的p值（p-value）分别为0.014与0.022），同时未对对比敏感度造成负面影响。临床结局不受瞳孔大小影响。 综上，由于该等焦人工晶状体的高度非球面设计使其中心屈光度提升，本研究评估的等焦人工晶状体相较单焦点标准晶状体具有更优异的中距离视觉效果。