UNASSIGNED: Double-masked, randomized, placebo-controlled clinical trial, the European Nutrition in Glaucoma Management Study (ClinicalTrials.gov identifier, NCT04460365).
UNASSIGNED: Sixty-two participants (38 men, 24 women) with a diagnosis of open-angle glaucoma were enrolled. Forty-two were randomized to receive the active supplement, 20 participants were allocated to placebo.
UNASSIGNED: Macular pigment optical density (MPOD) was measured by autofluorescence using the Heidelberg Spectralis scanning laser ophthalmoscope. Macular pigment optical density volume within the central 6° of retinal eccentricity as well as MPOD at 0.23°, 0.51°, 0.74°, and 1.02° were recorded at baseline and at 6-month intervals over 18 months. Visual function was assessed using visual acuity, mesopic and photopic contrast sensitivity under glare conditions, photo stress recovery time, microperimetry, and Glaucoma Activities Limitation 9 questionnaire. Advanced glaucoma module scans of retinal nerve fiber layer thickness and ganglion cell complex thickness over the central 6° of retinal eccentricity also were completed at each study visit.
UNASSIGNED: Change in MPOD after supplementation with 10 mg lutein, 2 mg zeaxanthin, and 10 mg meso-zeaxanthin or placebo over 18 months.
UNASSIGNED: A mixed-model repeated measures analysis of variance revealed a statistically significant increase in MPOD volume (significant time effect: F(3,111) = 89.31, mean square error (MSE) = 1656.9; P < 0.01). Post hoc t tests revealed a significant difference in MPOD volume at each study visit for the treatment group (P < 0.01 for all), but no change in the placebo group (P > 0.05 for all). A statistically significant increase in mesopic contrast sensitivity under glare conditions was noted at 18 months in the treatment group, but not placebo. No other structural or functional changes were observed. No serious adverse events were noted during the trial.
UNASSIGNED: Macular pigment can be augmented in glaucomatous eyes by supplementation with a formulation containing the carotenoids lutein, zeaxanthin, and meso-zeaxanthin. The greatest relative benefit was observed in those with the lowest baseline levels, but increases were noted across all participants and each retinal eccentricity. The potential benefits of MP augmentation for macular health in glaucoma merit further long-term evaluation.
未经评估:双重屏蔽,随机化,安慰剂对照临床试验,欧洲青光眼管理营养研究(ClinicalTrials.gov标识符,NCT04460365)。
未经评估:62名参与者(38名男性,纳入24名诊断为开角型青光眼的女性)。42人随机接受活性补充剂,20名参与者被分配到安慰剂组。
UNASSIGNED:使用海德堡光谱扫描激光检眼镜通过自发荧光测量黄斑色素光密度(MPOD)。视网膜偏心率中心6°内的黄斑色素光密度体积以及0.23°处的MPOD,0.51°,0.74°,在基线时和在18个月内以6个月的间隔记录1.02°.使用视敏度评估视觉功能,眩光条件下的mesopic和明视对比敏感度,照片应力恢复时间,显微视野,和青光眼活动限制9问卷。在每次研究访视时,还完成了视网膜神经纤维层厚度和视网膜偏心中央6°上神经节细胞复合物厚度的高级青光眼模块扫描。
未经批准:补充10mg叶黄素后MPOD的变化,2毫克玉米黄质,和10毫克内消旋玉米黄质或安慰剂超过18个月。
UNASSIGNED:混合模型重复测量方差分析显示,MPOD体积增加具有统计学意义(显着的时间效应:F(3,111)=89.31,均方误差(MSE)=1656.9;P<0.01)。事后t检验显示,治疗组在每次研究访视时MPOD体积存在显着差异(全部P<0.01),但安慰剂组无变化(均P>0.05)。在18个月时,治疗组中在眩光条件下观察到中视对比敏感度的统计学显着增加,但不是安慰剂。没有观察到其他结构或功能变化。试验期间未发现严重不良事件。
未经证实:通过补充含有类胡萝卜素叶黄素的制剂,可以增强青光眼的黄斑色素,玉米黄质,和内消旋玉米黄质.在基线水平最低的人群中观察到最大的相对益处,但是在所有参与者和每个视网膜偏心率中都注意到增加。MP增强对青光眼黄斑健康的潜在益处值得进一步长期评估。