Korobelnik Jean-François, Rougier Marie-Bénédicte, Delyfer Marie-Noëlle, Bron Alain, Merle Bénédicte M J, Savel Hélène, Chêne Geneviève, Delcourt Cécile, Creuzot-Garcher Catherine
Service d'Ophtalmologie, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France.
Universitaire Bordeaux, Institut National de la Santé et de la Récherche Médicale, Bordeaux Population Health Research Center, Team Lifelong Exposures Health and Aging (LEHA), Unité Mixte de Recherche (UMR) 1219, Bordeaux, France.
JAMA Ophthalmol. 2017 Nov 1;135(11):1259-1266. doi: 10.1001/jamaophthalmol.2017.3398.
Nutritional uptake of lutein, zeaxanthin, and ω-3 polyunsaturated fatty acids may increase macular pigment optical density (MPOD) and thereby protect against the development of age-related macular degeneration (AMD).
To estimate the efficiency of dietary supplementation containing lutein, zeaxanthin, ω-3 polyunsaturated fatty acids, and vitamins to increase the density of macular pigment in first-generation offspring of parents with neovascular AMD.
DESIGN, SETTING, AND PARTICIPANTS: This study was a randomized clinical trial (Lutein Influence on Macula of Persons Issued From AMD Parents [LIMPIA]) with a 6-month treatment period, followed by a 6-month follow-up period. Analyses were based on the intent-to-treat principle. The setting was 2 university hospitals in France (at Bordeaux and Dijon) from January 2011 (first participant first visit) to February 2013 (last participant last visit). The analysis was conducted from January to November 2016. Participants were 120 individuals free of any retinal ocular disease. They were first-generation offspring of parents with neovascular AMD.
Participants were randomized in a 1:1 ratio to receive either 2 daily dietary supplementation capsules or placebo for 6 months.
The primary assessment criterion was the evolution of MPOD after 6 months of supplementation (value of both eligible eyes) measured using the modified MPD-Visucam 200 (Carl Zeiss Meditec) and the modified Heidelberg Retina Angiograph (Heidelberg Engineering) (HRA) at 0.98° eccentricity. The statistical analysis was adjusted for hospital and for risk factors.
Overall, 120 participants (60 in each group) were included, and 239 eyes were analyzed (119 in the lutein plus zeaxanthin [L + Z] group and 120 in the placebo group). Their mean (SD) age was 56.7 (6.6) years, and 71.7% (n = 86) were female. A statistically significant increase in plasma lutein and zeaxanthin was shown in the L + Z group after 3 months and 6 months of treatment compared with the placebo group. However, the difference between groups in the evolution of MPOD measured by HRA 0.98° eccentricity between 6 months and baseline was 0.036 (95% CI, -0.037 to 0.110) (P = .33).
Among first-generation offspring of parents with neovascular AMD in the LIMPIA trial, MPOD as measured with the modified HRA and the MPD-Visucam was not modified after 6 months of lutein and zeaxanthin dietary supplementation despite plasma levels showing continuous exposure to lutein and zeaxanthin. Further research is necessary to understand the mechanism of absorption and metabolism of these nutrients in the macula, the best way to measure MPOD, and the clinical benefit for the patients.
clinicaltrials.gov Identifier: NCT01269697.
叶黄素、玉米黄质和ω-3多不饱和脂肪酸的营养摄取可能会增加黄斑色素光密度（MPOD），从而预防年龄相关性黄斑变性（AMD）的发生。
评估含有叶黄素、玉米黄质、ω-3多不饱和脂肪酸和维生素的膳食补充剂增加新生血管性AMD患者第一代后代黄斑色素密度的效果。
设计、地点和参与者：本研究为一项随机临床试验（AMD父母后代叶黄素对黄斑的影响[LIMPIA]），治疗期为6个月，随后为6个月的随访期。分析基于意向性治疗原则。研究地点为法国的2所大学医院（位于波尔多和第戎），时间从2011年1月（第一位参与者首次就诊）至2013年2月（最后一位参与者最后就诊）。分析于2016年1月至11月进行。参与者为120名无任何视网膜眼部疾病的个体。他们是新生血管性AMD患者的第一代后代。
参与者按1:1比例随机分组，接受每日2粒膳食补充剂胶囊或安慰剂，为期6个月。
主要评估标准为补充6个月后MPOD的变化（双眼合格值），使用改良的MPD-Visucam 200（卡尔蔡司医疗技术公司）和改良的海德堡视网膜血管造影仪（海德堡工程公司）（HRA）在偏心度0.98°处测量。统计分析对医院和危险因素进行了校正。
总体而言，纳入了120名参与者（每组60名），分析了239只眼（叶黄素加玉米黄质[L+Z]组119只，安慰剂组120只）。他们的平均（标准差）年龄为56.7（6.6）岁，71.7%（n=86）为女性。与安慰剂组相比，L+Z组在治疗3个月和6个月后血浆叶黄素和玉米黄质有统计学显著增加。然而，两组在6个月时和基线时HRA偏心度0.98°处测量的MPOD变化差异为0.036（95%CI，-0.037至0.110）（P=0.33）。
在LIMPIA试验中，新生血管性AMD患者的第一代后代中，尽管血浆水平显示持续摄入叶黄素和玉米黄质，但在补充叶黄素和玉米黄质6个月后，使用改良HRA和MPD-Visucam测量的MPOD并未改变。有必要进一步研究以了解这些营养素在黄斑中的吸收和代谢机制、测量MPOD的最佳方法以及对患者的临床益处。
clinicaltrials.gov标识符：NCT01269697。
