Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8174-8. doi: 10.1167/iovs.11-7522.
There is evidence from several large-scale clinical trials that reduced intake of lutein, a major component of the macular pigment, is a risk factor for the development of AMD. In the present study (LISA; Lutein Intervention Study Austria) it was hypothesized that lutein supplementation increases macular pigment optical density (MPOD). In addition, an investigation was conducted into whether lutein supplementation improves visual acuity (VA) and macular function (mean differential light threshold; MDLT), as assessed with microperimetry.
One hundred twenty-six patients with AMD (AREDS [Age-related Eye Disease Study] stages 2, 3, and 4) were included in this randomized (2:1), placebo-controlled, double-masked parallel group study. Lutein or placebo was administered for 6 months. MPOD was measured with a custom-built reflectometer. VA was assessed with ETDRS (Early Treatment Diabetic Retinopathy Study) charts, and MDLT was assessed with a microperimeter.
Lutein significantly increased MPOD by 27.9% ± 2.9% (P < 0.001 versus placebo). No significant effect of lutein supplementation on MDLT or VA was seen, although a tendency toward an increase was seen for both parameters (MDLT, P = 0.096 versus placebo; VA, P = 0.070 versus placebo). A significant correlation was found, however, between the increase in MPOD after 6 months and the increase in MDLT after 6 months (r = 0.25, P = 0.027), as well as between the increase in MPOD after 6 months and the increase in VA after 6 months (r = 0.27, P = 0.013).
The present study demonstrates that lutein supplementation increases MPOD, as assessed with an objective
The correlation between the change in MPOD and the change in VA and MDLT indicates that patients who show a pronounced increase in MPOD also benefit in terms of visual function. (ClinicalTrials.gov number, NCT00879671.).
多项大规模临床试验的证据表明,黄斑色素主要成分叶黄素的摄入量减少是 AMD 发展的一个风险因素。在本研究(LISA;叶黄素干预奥地利研究)中,假设叶黄素补充剂可以增加黄斑色素光学密度(MPOD)。此外,还研究了叶黄素补充剂是否可以改善视力(VA)和黄斑功能(平均差分光阈值;MDLT),并使用微视野计进行评估。
本研究纳入了 126 名 AMD 患者(AREDS [年龄相关性眼病研究] 2、3 和 4 期),采用随机(2:1)、安慰剂对照、双盲平行组研究。给予叶黄素或安慰剂治疗 6 个月。使用定制的反射计测量 MPOD。VA 用 ETDRS(早期糖尿病性视网膜病变治疗研究)图表评估,MDLT 用微视野计评估。
叶黄素可使 MPOD 显著增加 27.9%±2.9%(P<0.001 与安慰剂相比)。叶黄素补充剂对 MDLT 或 VA 没有显著影响,但这两个参数都有增加的趋势(MDLT,P=0.096 与安慰剂相比;VA,P=0.070 与安慰剂相比)。然而,在 6 个月后,MPOD 的增加与 MDLT 的增加之间存在显著相关性(r=0.25,P=0.027),以及在 6 个月后,MPOD 的增加与 VA 的增加之间存在显著相关性(r=0.27,P=0.013)。
本研究表明,叶黄素补充剂可增加 MPOD,通过客观评估。
MPOD 变化与 VA 和 MDLT 变化之间的相关性表明,MPOD 显著增加的患者在视觉功能方面也受益。(临床试验.gov 编号,NCT00879671)。