Charbel Carla, Pérez-Sanz Lidia, Garzón Nuria, Poyales Francisco, Carballo Jesús
Optometry and Vision Department, Faculty of Optics and Optometry, Complutense University of Madrid, C/Arcos de Jalón, 118, 28037 Madrid, Spain.
Miranza IOA Clinic, C/Galileo, 104, 28003 Madrid, Spain.
J Clin Med. 2025 Sep 4;14(17):6255. doi: 10.3390/jcm14176255.
The objective of this study is to compare the optical and visual quality provided by the advanced monofocal intraocular lens (IOL) ISOPure and the standard monofocal IOL MicroPure in cataract patients, using objective and subjective assessments. This prospective, single-blind clinical study includes 28 patients with cataracts, bilaterally implanted with either the ISOPure or MicroPure IOL. Eligible eyes had no ocular comorbidities and regular corneal astigmatism ≤ 1.00 D. Three months postoperatively, uncorrected distance and intermediate (UDVA, UIVA) and corrected distance and intermediate (CDVA, DCIVA) visual acuities were measured at 4 m, 80 cm, and 66 cm under photopic (85 cd/m) and mesopic (3.5 cd/m) conditions. Photic phenomena, including halo and glare, were evaluated. Objective optical quality was assessed using Objective Scattering Index (OSI), Modulation Transfer Function (MTF), Strehl Ratio (SR), and ocular aberrations. Subjective patient satisfaction was evaluated using Quality of Vision (QoV) and Catquest-9SF questionnaires. Under photopic conditions, logMAR DCIVA at 80 cm, UIVA at 66 cm, and DCIVA at 66 cm were 0.18 ± 0.06, 0.25 ± 0.12, and 0.20 ± 0.13, respectively, for ISOPure, and 0.22 ± 0.06, 0.30 ± 0.09, and 0.25 ± 0.09 for MicroPure ( = 0.05, 0.02, and 0.05, respectively). No significant differences were observed in halo/glare size or intensity, OSI, MTF, or SR. However, statistically significant differences were found in higher-order total aberrations for pupil sizes of 3.0, 4.0 mm, and 5.0 mm. Questionnaires indicated greater satisfaction and functional intermediate vision with ISOPure. The ISOPure IOL offers superior intermediate vision without compromising distance vision, delivering a balanced combination of optical quality, functional performance, and patient satisfaction.
本研究的目的是通过客观和主观评估，比较先进的单焦点人工晶状体（IOL）ISOPure和标准单焦点IOL MicroPure在白内障患者中提供的光学和视觉质量。这项前瞻性、单盲临床研究纳入了28例双侧植入ISOPure或MicroPure IOL的白内障患者。符合条件的眼睛无眼部合并症且规则角膜散光≤1.00 D。术后三个月，在明视（85 cd/m）和中视（3.5 cd/m）条件下，于4 m、80 cm和66 cm处测量未矫正远距和中距（UDVA、UIVA）以及矫正远距和中距（CDVA、DCIVA）视力。评估了包括光晕和眩光在内的明视现象。使用客观散射指数（OSI）、调制传递函数（MTF）、斯特列尔比率（SR）和眼像差评估客观光学质量。使用视觉质量（QoV）和Catquest-9SF问卷评估患者主观满意度。在明视条件下，ISOPure在80 cm处的logMAR DCIVA、66 cm处的UIVA和66 cm处的DCIVA分别为0.18±0.06、0.25±0.12和0.20±0.13，而MicroPure分别为0.22±0.06、0.30±0.09和0.25±0.09（分别为P = 0.05、0.02和0.05）。在光晕/眩光大小或强度、OSI、MTF或SR方面未观察到显著差异。然而，在瞳孔大小为3.0、4.0 mm和5.0 mm时，高阶总像差存在统计学显著差异。问卷显示患者对ISOPure的满意度更高且中距视觉功能更好。ISOPure IOL在不影响远距视力的情况下提供了卓越的中距视力，实现了光学质量、功能性能和患者满意度的平衡组合。
