Li Boliang, Chen Xun, Cheng Mingrui, Lin I-Chun, Jiang Yinjie, Lei Yadi, Xu Guanghan, Li Mingwei, Mao Zhiwei, Zhou Xingtao, Wang Xiaoying
Eye Ear Nose and Throat Hospital, Fudan University, Shanghai, China.
National Health Commission Key Lab of Myopia (Fudan University), Shanghai, China.
Front Med (Lausanne). 2025 Jul 9;12:1438569. doi: 10.3389/fmed.2025.1438569. eCollection 2025.
Assess the efficacy, safety, and visual quality of two posterior chamber phakic intraocular lenses (PIOL) for myopia correction.
In this randomized double-blind prospective controlled trial, 38 eyes of 19 myopic patients received phakic refractive (PR) IOL in one eye and implantable collamer lens (EVO ICL) in the opposite eye and were followed up for 1 year. Uncorrected distance visual acuity, corrected distance visual acuity, vault, disk halo size, contrast sensitivity, higher-order aberrations, retinal imaging quality, intraocular scattering, and subjective glare/halo perception were measured.
At 1 year, mean efficacy indices were 1.03 ± 0.16 (PR) and 1.01 ± 0.15 (ICL), and mean safety indices were 1.18 ± 0.07 (PR) and 1.15 ± 0.09 (ICL). The PR group had lower vaults than those of the ICL group at 1 year (342.63 ± 153.94 vs. 470.00 ± 230.31 μm, = 0.010). One month postoperatively, the severity of glare/halo was significantly milder in the PR group than that in the ICL group ( = 0.035). However, 1 year postoperatively, no significant differences were observed in the severity of glare/halo between the two groups.
Phakic refractive implantation is a safe and effective treatment option for myopia. The PR group exhibited lower vaults than those of the ICL group. The PR group had milder glare/halo in the early postoperative period compared to the ICL group, though long-term differences were not significant.
评估两种后房型有晶状体眼人工晶状体(PIOL)矫正近视的疗效、安全性及视觉质量。
在这项随机双盲前瞻性对照试验中,19例近视患者的38只眼,一只眼植入有晶状体眼屈光(PR)人工晶状体,另一只眼植入可植入式角膜接触镜(EVO ICL),并随访1年。测量裸眼远视力、矫正远视力、前房深度、盘状光晕大小、对比敏感度、高阶像差、视网膜成像质量、眼内散射以及主观眩光/光晕感知。
1年后,平均疗效指数PR组为1.03±0.16,ICL组为1.01±0.15;平均安全指数PR组为1.18±0.07,ICL组为1.15±0.09。1年后PR组的前房深度低于ICL组(342.63±153.94 vs. 470.00±230.31μm,P = 0.010)。术后1个月,PR组眩光/光晕的严重程度明显低于ICL组(P = 0.035)。然而,术后1年,两组之间眩光/光晕的严重程度未观察到显著差异。
有晶状体眼屈光植入术是一种安全有效的近视治疗选择。PR组的前房深度低于ICL组。与ICL组相比,PR组术后早期眩光/光晕较轻,尽管长期差异不显著。