Shammas Maya C, Shammas H John
The Department of Ophthalmology, The Shammas Eye Medical Center, Lynwood, CA, USA.
The Department of Ophthalmology, University of Southern California, The Keck School of Medicine, Los Angeles, CA, USA.
Clin Ophthalmol. 2024 Dec 31;18:4063-4070. doi: 10.2147/OPTH.S495545. eCollection 2024.
To evaluate the clinical outcomes of a new FDA approved toric aspheric hydrophobic acrylic intraocular lens.
This is a single surgeon, single-arm, on-label, non-randomized, prospective observational study. Thirty patients underwent bilateral cataract surgery (60 eyes) with placement of a Clareon™ Toric IOL in each eye. The Barrett Universal II formula and Barrett toric calculator were used to determine the IOL power and toric axis. Endpoints included binocular and monocular best corrected distance visual acuity (BCDVA), binocular and monocular best uncorrected distance visual acuity (UCDVA), binocular uncorrected intermediate visual acuity (UCIVA), manifest refraction and patient Satisfaction Survey (IOLSAT) results over a 3 month follow-up.
The postoperative mean LogMAR visual acuity for binocular BCDVA and UCDVA were each 0.01±0.05. The monocular BCDVA and UCDVA were 0.04±0.06 and 0.08±0.08 respectively. The mean refractive cylinder improved from 1.87±1.12D to 0.43±0.25D with 78.3% within 0.50D. The mean refractive spherical equivalent (MRSE) was 0.008 ± 0.30 D (range -0.75 to +0.63, 93.3% results within ± 0.5D). Patient surveys showed 96.7% gained distance spectacle independence and 96.7% would recommend this lens to friends or family members.
The Clareon Monofocal Toric IOL is effective in astigmatism correction and significantly improved uncorrected distance visual acuity. High spectacle independence for distance vision and high overall satisfaction were achieved.
评估一种新的经美国食品药品监督管理局(FDA)批准的复曲面非球面疏水丙烯酸人工晶状体的临床效果。
这是一项由单一外科医生进行的单臂、符合标签规定、非随机、前瞻性观察性研究。30例患者接受了双眼白内障手术(60只眼),每只眼植入一枚Clareon™复曲面人工晶状体。使用巴雷特通用II公式和巴雷特复曲面计算器来确定人工晶状体的度数和复曲面轴。观察指标包括3个月随访期内的双眼及单眼最佳矫正远视力(BCDVA)、双眼及单眼最佳未矫正远视力(UCDVA)、双眼未矫正中间视力(UCIVA)、显验光和患者满意度调查(IOLSAT)结果。
双眼BCDVA和UCDVA术后平均LogMAR视力均为0.01±0.05。单眼BCDVA和UCDVA分别为0.04±0.06和0.08±0.08。平均屈光柱镜从1.87±1.12D改善至0.43±0.25D,78.3%在0.50D以内。平均屈光球镜等效值(MRSE)为0.008±0.30D(范围为-0.75至+0.63,93.3%的结果在±0.5D以内)。患者调查显示,96.7%的患者在看远时无需依赖眼镜,96.7%的患者会向朋友或家人推荐这款人工晶状体。
Clareon单焦点复曲面人工晶状体在矫正散光方面有效,显著提高了未矫正远视力。实现了较高的看远不依赖眼镜率和较高的总体满意度。