Ferrando Gil Javier, Churruca Irazola Adela, Reparaz Iraia, Lauzirika Gorka, Martínez-Soroa Itziar, Mendicute Javier
Department of Ophthalmology, Donostia University Hospital, Donostia-San Sebastián, Spain.
Miranza Begitek, Donostia-San Sebastián, Spain.
Clin Ophthalmol. 2024 Dec 17;18:3801-3813. doi: 10.2147/OPTH.S499911. eCollection 2024.
To describe the visual, refractive, functional, and patient satisfaction outcomes of the Bi-Flex POB-MA 877PEY (Elon, Medicontur Medical Engineering Ltd. Zsámbék, Hungary) extended depth-of-focus intraocular lens (EDoF IOL).
This was a prospective longitudinal descriptive study. Patients who underwent cataract surgery with the implantation of Bi-Flex POB-MA 877PEY IOL were included. Monocular refractive outcomes and visual acuity at distance, intermediate, and near were evaluated 1- and 3-month post-op. Binocular contrast sensitivity (CSV-1000, VectorVision, USA), binocular defocus curve, and patient satisfaction with the Visual Functioning Questionnaire (VFQ) were assessed at 3-month post-op.
20 Bi-Flex POB-MA 877PEY IOL were implanted bilaterally in 10 patients. The mean age of the patients was 68.60±4.45 years. At 1-month post-op the monocular Corrected Distance Visual Acuity (CDVA), intermediate (CIVA) and near (CNVA) was 0.02±0.03, 0.29±0.08, and 0.40±0.05 LogMAR respectively. At 3-month post-op the CDVA decrease to 0.05±0.06 LogMAR (p=0.042), and CIVA and CNVA remained stable at 3-month post-op (p>0.05). No statistical differences were found in post-op spherical equivalent at 1 and 3 month (-0.03±0.19 D and -0.03±0.13 D; p=1.000). 100% of eyes were within ±0.5 D at 1 month and 3-month post-op. Binocular defocus curve shows a peak of maximum visual acuity (VA) at 0 D (0.00±0.04 LogMAR), and a constant and progressive decrease at -1.50 D, and -2.50 D (0.15±0.08 LogMAR and 0.33±0.10 LogMAR, respectively). Contrast sensitivity decreased at high spatial frequencies. In patient satisfaction at 3 months post-op, VFQ reveals that 90% of patients revealed no or minor difficulty with glare/flare and 100% of patients have no or minor difficulty with halos. In overall satisfaction, 80% of patients rate their vision between 8 and 9 from a scale from 0 to 10.
The Bi-Flex POB-MA 877PEY EDoF IOL provides good visual outcomes for distance, and adequate intermediate vision, with low visual disturbances.
描述Bi-Flex POB-MA 877PEY（匈牙利Zsámbék的Medicontur Medical Engineering Ltd.公司的Elon）扩展焦深人工晶状体（EDoF IOL）的视觉、屈光、功能及患者满意度结果。
这是一项前瞻性纵向描述性研究。纳入接受白内障手术并植入Bi-Flex POB-MA 877PEY IOL的患者。术后1个月和3个月评估单眼屈光结果以及远、中、近视力。术后3个月评估双眼对比敏感度（CSV-1000，美国VectorVision公司）、双眼散焦曲线以及患者对视觉功能问卷（VFQ）的满意度。
10例患者双侧植入20枚Bi-Flex POB-MA 877PEY IOL。患者平均年龄为68.60±4.45岁。术后1个月，单眼矫正远视力（CDVA）、中视力（CIVA）和近视力（CNVA）分别为0.02±0.03、0.29±0.08和0.40±0.05 LogMAR。术后3个月，CDVA降至0.05±0.06 LogMAR（p=0.042），CIVA和CNVA在术后3个月保持稳定（p>0.05）。术后1个月和3个月的等效球镜度无统计学差异（-0.03±0.19 D和-0.03±0.13 D；p=1.000）。术后1个月和3个月时，100%的眼等效球镜度在±0.5 D以内。双眼散焦曲线显示在0 D时最大视力（VA）出现峰值（0.00±0.04 LogMAR），在-1.50 D和-2.50 D时视力持续且逐渐下降（分别为0.15±0.08 LogMAR和0.33±0.10 LogMAR）。高空间频率下对比敏感度下降。术后3个月患者满意度方面，VFQ显示90%的患者眩光/光晕无或仅有轻微困难，100%的患者光环无或仅有轻微困难。总体满意度方面，80%的患者对其视力在0至10分的评分中为8至9分。
Bi-Flex POB-MA 877PEY EDoF IOL可提供良好的远视力及足够的中视力，视觉干扰低。
