JPRN-UMIN000004804已完成未知
Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab) - The comparative study on the effects of lutein and omega3 fatty acids supplements to age-related macular degeneration
Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)0 个研究点目标入组 28 人开始时间: 2010年12月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
The mean macular pigment optical density levels increased at month 12 compared to the baseline in all groups, but a statistically significant increase was observed only in group MMLD (multivitamins and minerals plus 12 mg lutein, p=0.023, Wilcoxon signed rank test). The mean frequency of retreatment was 2.6 in group MM ( multivitamins and minerals), 3.3 in group MML, and 1.6 in MMLD (multivitamins and minerals, plus lutein and 144 mg docosahexaenoic acid, p=0.338, Kruskal-Wallis test).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Presence of cataracts of a severity sufficient to materially affect the above evaluations of visual function (2)Undergone cataract surgery within the previous 3 months (3)Pupile size of less than 6.5 mm (4)Presence of glaucoma, diabetic retinopathy, or other serious disease of the fundus (5)Myopia of -6D or higher (6)Presence of hepatopathy, nephropathy, or cardiac disease of a severity sufficient to affect the evaluations of the supplements to be taken by patients (7)Receiving photosensitive drugs such as phenothiazine, chloroquine, and tetracycline on an ongoing basis (8)Regular use of lutein or DHA in the past 3 months (9)Judged by the investigator to be ineligible for other reasons
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