Shah Sunil, Peris-Martinez Cristina, Reinhard Thomas, Vinciguerra Paolo
J Refract Surg. 2015 Oct;31(10):658-66. doi: 10.3928/1081597X-20150611-01.
To evaluate visual outcomes, spectacle independence, and quality of life among nonastigmatic and astigmatic patients who received AcrySof IQ ReSTOR toric or nontoric multifocal intraocular lenses (IOLs) (Alcon Laboratories, Fort Worth, TX) compared with those who received commercially available nontoric monofocal IOLs after bilateral cataract removal.
This randomized, patient- and observer-technician-masked study was conducted at 20 sites in Europe. Patients were randomized to receive monofocal (nontoric only) or multifocal (nontoric or toric, as needed) IOLs. Primary efficacy endpoints included percentage of patients achieving binocular uncorrected distance and near acuity of 0.1 logMAR or better (20/25 Snellen), spectacle independence, and scores on the National Eye Institute Refractive Error and Quality of Life questionnaire domains. Safety endpoints included adverse events and refractive error within 0.5 and 1.0 diopters.
In the multifocal group (n = 108) versus the monofocal group (n = 100), significantly more patients achieved uncorrected distance and near acuity of 0.1 logMAR or better (45.7% vs 2.1%; P < .0001) and spectacle independence (73.3% vs 25.3%; P < .0001) at 6 months. The percentage of patients who achieved uncorrected distance visual acuity of 20/40 or better at 6 months was 92% in the multifocal group and 97% in the monofocal group. National Eye Institute Refractive Error and Quality of Life scores were significantly better for dependence on correction in the multifocal group (P < .0001) and for glare in the monofocal group (P = .0157); other domain scores were similar between groups. No significant trends in study device-related adverse events were observed.
Monofocal and multifocal IOLs provided good clinical outcomes. More patients receiving multifocal IOLs attained better uncorrected visual acuity at a range of distances and spectacle independence compared with patients who received monofocal IOLs. Monofocal IOLs were associated with better patient-reported scores for glare compared with multifocal IOLs; however, scores for patient satisfaction were significantly better in the multifocal group.
评估接受AcrySof IQ ReSTOR散光或非散光多焦点人工晶状体(IOL)(爱尔康实验室,沃思堡,德克萨斯州)的非散光和散光患者与双侧白内障摘除术后接受市售非散光单焦点IOL的患者相比的视觉效果、摆脱眼镜依赖情况和生活质量。
这项随机、患者及观察者-技术人员双盲研究在欧洲的20个地点进行。患者被随机分配接受单焦点(仅非散光)或多焦点(根据需要为非散光或散光)IOL。主要疗效终点包括双眼未矫正远视力和近视力达到0.1 logMAR或更好(20/25 Snellen)的患者百分比、摆脱眼镜依赖情况以及国立眼科研究所屈光不正和生活质量问卷各领域的得分。安全性终点包括不良事件以及0.5和1.0屈光度范围内的屈光不正。
在多焦点组(n = 108)与单焦点组(n = 100)中,6个月时,达到未矫正远视力和近视力0.1 logMAR或更好的患者明显更多(45.7% 对2.1%;P <.0001),且摆脱眼镜依赖的患者更多(73.3% 对25.3%;P <.0001)。多焦点组6个月时未矫正远视力达到20/40或更好的患者百分比为92%,单焦点组为97%。国立眼科研究所屈光不正和生活质量得分在多焦点组中因依赖矫正方面明显更好(P <.0001),在单焦点组中因眩光方面明显更好(P =.0157);其他领域得分在两组之间相似。未观察到与研究器械相关的不良事件有显著趋势。
单焦点和多焦点IOL均提供了良好的临床效果。与接受单焦点IOL的患者相比,更多接受多焦点IOL的患者在一系列距离上获得了更好的未矫正视力且摆脱了眼镜依赖。与多焦点IOL相比,单焦点IOL在患者报告的眩光得分方面更好;然而,多焦点组的患者满意度得分明显更好。