Hervás-Ontiveros Ana, España-Gregori Enrique, Fresno-Cañada Carlos, Butrón-Ruíz Rodrigo, Cerviño Alejandro
Department of Ophthalmology, Hospital Universitario La Fe, Valencia, Spain.
Department of Ophthalmology, Hospital 9 de Octubre, Valencia, Spain.
J Ophthalmol. 2024 Dec 31;2024:3520219. doi: 10.1155/joph/3520219. eCollection 2024.
This study aims to analyze the prevalence and severity of posterior capsule opacification (PCO) and glistening in a new hydrophobic biaspheric monofocal intraocular lens (IOLs) 24 months after implantation. By means of a ambispective, observational, case-control design, a total of 297 eyes from 200 cataract surgery patients were included in the study (118 females and 82 males; mean age: 72.31 ± 9.87 years, ranging from 35 to 92) and examined at the Hospital Universitario y Politécnico la Fe, Valencia (Spain). Data corresponding to patients implanted with either Asqelio (Study IOL) or Clareon (Control IOL) monofocal IOLs at least 24 months prior to study visit were analyzed. Prevalence and intensity of PCO and IOL glistening were determined and graded for both groups by a single masked observer. Refractive outcomes by autorefractometry, visual acuity, and wavefront aberrations determined by ray tracing were also measured and compared. Prevalence of PCO in patients implanted with the Study IOL 24 months after implantation was 4.0%, lower than that for the Control IOL. Intensity of PCO in both groups was low. One lens in each group presented a Grade 1 glistening after 24 months from implantation. Differences in visual acuity between Study and Control Groups were not significant (=0.260 and 0.115 for UDVA and CVA, respectively). Residual spherical aberration was significantly lower in the Study Group than that in the Control Group (=0.007). Prevalence of PCO was considerably lower for Asqelio IOL than for the Control IOL and reports available in the literature for other hydrophobic IOLs. Prevalence of glistening was minimal in both study and control IOLs. ClinicalTrials.gov identifier: NCT04971863.
本研究旨在分析一种新型疏水双非球面单焦点人工晶状体(IOL)植入24个月后后囊膜混浊(PCO)和闪烁的发生率及严重程度。通过前瞻性、观察性、病例对照设计,本研究纳入了200例白内障手术患者的297只眼(118例女性和82例男性;平均年龄:72.31±9.87岁,范围为35至92岁),并在西班牙巴伦西亚的拉斐尔大学医院和理工大学进行检查。分析了在研究访视前至少24个月植入Asqelio(研究IOL)或Clareon(对照IOL)单焦点IOL的患者的数据。由一名单盲观察者确定并分级两组PCO和IOL闪烁的发生率及强度。还测量并比较了自动验光的屈光结果、视力以及通过光线追踪确定的波前像差。植入研究IOL 24个月后患者的PCO发生率为4.0%,低于对照IOL。两组PCO的强度均较低。每组各有一枚晶状体在植入24个月后出现1级闪烁。研究组和对照组之间的视力差异不显著(UDVA和CVA分别为0.260和0.115)。研究组的残余球差显著低于对照组(0.007)。Asqelio IOL的PCO发生率明显低于对照IOL以及文献中报道的其他疏水IOL。研究IOL和对照IOL的闪烁发生率均极低。ClinicalTrials.gov标识符:NCT04971863。