UNASSIGNED:评估非衍射扩展视力人工晶状体(AcrySofIQVivity)与单焦点对照的长期(>1年)结果。
UNASSIGNED:这是一项多中心试验,在美国4个独立的私人眼科实践中进行。
未经批准:这是一个潜在的,非干预性,控制,多中心试验。所有受试者均来自食品和药物管理局(FDA)临床试验的参与者,该试验获得了AcrySofIQVivity的批准。
未经授权:双眼未矫正视力(UCDVA),远距矫正视力(DCVA),未矫正视力(UIVA)在66cm,距离矫正视力(DCIVA)在66cm,未矫正的近视力(UNVA)在40厘米,测量40cm处的距离校正近视力(DCNVA)。测量双眼散焦曲线。关于视觉表现的23个问题的调查,包括关于眼镜独立性的问题,满意,消化不良,并且使用了向他人推荐他们的镜片的可能性。
未经评估:共纳入32名受试者的64只眼。17名受试者双侧植入了AcrySofIQVivity晶状体,15名受试者双侧植入了AcrySofIQ单焦点(SN60WF)。研究组的平均随访时间为1078天,对照组为1067天(p=0.92)。两组间UCVA或DCVA差异无统计学意义。与控制相比,AcrySofIQ活性组的平均双眼UIVA较好(logMAR为0.29vs0.18;p=0.09),DCIVA(logMAR0.33vs0.11;p=0.003),UNVA(logMAR0.49vs0.30,p=0.01),和DCNVA(logMAR为0.54vs0.29;p=0.001)。
未经授权:AcrySofIQVivity是一部小说,非衍射扩展范围的视力人工晶状体,提供长期,增强中等和近范围的视力,具有较高的患者满意度和最小的吞吐困难。
UNASSIGNED: To evaluate the long-term (>1 yr) outcomes a non-diffractive extended vision intraocular lens (AcrySof IQ Vivity) compared to monofocal control.
UNASSIGNED: This was a multicenter
trial that took place in 4 separate private ophthalmology practices throughout the United States.
UNASSIGNED: This was a prospective, non-interventional, controlled, multicenter
trial. All subjects were enrolled from participants in the Food and Drug Administration (FDA) clinical
trial that led to the approval of the AcrySof IQ Vivity.
UNASSIGNED: Binocular uncorrected distance visual acuity (UCDVA), distance corrected visual acuity (DCVA), uncorrected intermediate visual acuity (UIVA) at 66cm, distance corrected intermediate visual acuity (DCIVA) at 66cm, uncorrected near visual acuity (UNVA) at 40cm, and distance corrected near visual acuity (DCNVA) at 40cm were measured. The binocular defocus curve was measured. A 23-question survey on visual performance including questions on spectacle independence, satisfaction, dysphotopsias, and likelihood of recommending their lens to another person was used administered.
UNASSIGNED: A total of 64 eyes of 32 subjects were enrolled. Seventeen subjects had bilateral implantation of the AcrySof IQ Vivity lens, and 15 subjects had bilateral implantation of the AcrySof IQ Monofocal (SN60WF). Mean follow up time was 1078 days for the
study group compared to 1067 days for the control group (p = 0.92). There were no differences in UCVA or DCVA between the two groups. Compared to control, the AcrySof IQ Vivity group had better mean binocular UIVA (logMAR 0.29 vs 0.18; p = 0.09), DCIVA (logMAR 0.33 vs 0.11; p = 0.003), UNVA (logMAR 0.49 vs 0.30, p = 0.01), and DCNVA (logMAR 0.54 vs 0.29; p = 0.001).
UNASSIGNED: The AcrySof IQ Vivity is a novel, non-diffractive extended range of vision intraocular lens that provides long-term, enhanced visual acuity at intermediate and near ranges with high levels of patient satisfaction and minimal dysphotopsias.