Moorfields Eye Hospital, London, United Kingdom; University College London, Institute of Ophthalmology, London, United Kingdom.
Moorfields Eye Hospital, London, United Kingdom; University College London, Institute of Ophthalmology, London, United Kingdom.
Ophthalmology. 2013 Dec;120(12):2449-2455.e1. doi: 10.1016/j.ophtha.2013.07.048. Epub 2013 Sep 23.
To compare spectacle independence in patients randomized to receive bilateral multifocal intraocular lenses (IOLs) or monofocal IOLs with the powers adjusted to produce monovision.
Randomized, multicenter clinical trial.
A total of 212 patients with bilateral, visually significant cataract.
Before bilateral sequential cataract surgery, patients were randomized (allocation ratio 1:1) to receive bilateral Tecnis ZM900 diffractive multifocal lenses (Abbott Medical Optics, Santa Ana, CA) or Akreos AO monofocal lenses (Bausch & Lomb, Rochester, NY) with the powers adjusted to target -1.25 diopters (D) monovision. Outcomes were assessed 4 months after the second eye underwent operation.
The primary outcome was spectacle independence. Secondary outcomes included questionnaires (VF-11R, dysphotopsia symptoms, and satisfaction) and visual function measures (near, intermediate, and distance logarithm of minimum angle of resolution [logMAR] visual acuity, stereoacuity, contrast sensitivity, and forward light scatter).
A total of 212 patients were randomized, and 187 patients (88%) returned for assessment 4 months after surgery. Uniocular distance refractions in the monovision arm showed a mean spherical equivalent of +0.075 D in the distance eye and -0.923 in the near eye. In the multifocal arm, the mean distance spherical equivalents were -0.279 D and -0.174 D in the right and left eyes, respectively. A total of 24 of 93 patients (25.8%) in the monovision arm and 67 of 94 patients (71.3%) in the multifocal arm reported never wearing glasses (P<0.001, Fisher exact test). The adjusted odds ratio of being spectacle free was 7.51 (95% confidence interval, 3.89-14.47). Binocular uncorrected acuities did not differ significantly for distance (0.058 logMAR for monovision vs. 0.076 for multifocal, P = 0.3774) but were significantly worse in the multifocal arm for intermediate acuity (0.149 vs. 0.221, P = 0.0001) and in the monovision arm for near acuity (0.013 vs. -0.025, P = 0.037). In the first postoperative year, 6 patients (5.7%) in the multifocal arm underwent IOL exchange (4 had a bilateral and 2 had a unilateral exchange). No patients in the monovision arm underwent IOL exchange.
Patients randomized to bilateral implantation with the diffractive multifocal Tecnis ZM900 were more likely to report being spectacle independent but also more likely to undergo IOL exchange than those randomized to receive monofocal implants (Akreos AO) with the powers adjusted to give low monovision.
比较随机分配接受双侧多焦点人工晶状体（IOL）或单焦点 IOL 并将其调整为单视的患者的眼镜独立性。
随机、多中心临床试验。
共 212 名双侧视力显著白内障患者。
在双眼顺序白内障手术后 4 个月，患者被随机（分配比 1:1）接受双侧 Tecnis ZM900 衍射多焦点晶状体（雅培医疗光学公司，圣安娜，加利福尼亚州）或 Akreos AO 单焦点晶状体（博士伦，罗切斯特，纽约），并将其调整为 -1.25 屈光度（D）单视。术后第 2 只眼评估 4 个月后评估结果。
主要结局为眼镜独立性。次要结局包括问卷调查（VF-11R、畏光症状和满意度）和视觉功能测量（近、中、远距离最小角分辨率对数[logMAR]视力、立体视锐度、对比敏感度和前向光散射）。
共有 212 名患者被随机分配，187 名患者（88%）在手术后 4 个月返回评估。单视眼的单眼距离折射显示远视眼的平均球镜当量为+0.075 D，而近眼的平均球镜当量为-0.923 D。在多焦点臂中，右眼和左眼的平均距离球镜当量分别为-0.279 D 和-0.174 D。在单视臂中，24 名 93 名患者（25.8%）和多焦点臂中 67 名 94 名患者（71.3%）报告从未戴过眼镜（P<0.001，Fisher 确切检验）。不需要戴眼镜的调整后优势比为 7.51（95%置信区间，3.89-14.47）。双眼未矫正视力在距离上无显著差异（单视 0.058 logMAR，多焦点 0.076，P = 0.3774），但多焦点臂的中间视力（0.149 对 0.221，P = 0.0001）和单视臂的近视力（0.013 对-0.025，P = 0.037）明显较差。在术后第 1 年，多焦点臂中有 6 名患者（5.7%）接受了 IOL 置换（4 名双侧，2 名单侧）。单视臂中没有患者接受 IOL 置换。
与随机接受单焦点 IOL（Akreos AO）植入并调整为低单视的患者相比，随机接受双侧衍射多焦点 Tecnis ZM900 植入的患者更有可能报告眼镜独立性，但也更有可能接受 IOL 置换。
