JPRN-UMIN000007628已完成未知
A multi-center, randomized, parallel-group study to assess the changes in macular pigment density and visual performance in the patients with age-related macular degeneration, who received a lutein supplement - A multi-center study to assess the macular pigment density and visual performance in age-related macular degeneration
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
There was no statistically significant difference in the mean MPOD at baseline between both groups. The MPODs were almost equivalent after six months in both groups. There was no significant difference in the mean serum utein concentration at baseline between both groups. The mean serum concentration increased in six months, although it wasn't significant. In lutein group, 23 subjects showed increase of serum concentration of more than 20% that was significantly higher than placebo group.(p=0.035)
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
- •Eye with cataract to the degree having substantial effects on the measurement of the macular pigment density. Exclude nuclear cataract of Grade 2 or severer nuclear sclerosis. The subject should be disqualified when having marked progression of cataract in the subject eye during the study period. The subject should be disqualified when undergoing the cataract surgery during the study period. Eye of which mydriatic pupil diameter is less than 6.5 mm Eye with glaucoma, diabetic retinopathy, or other serious disease Myopia of -6D or over Patient having as severe hepatic/renal impairment or cardiac disease as affecting the evaluation of the investigational supplement Patient continuously treated with any photo-sensitive drug (phenothiazine, chloroquine, tetracycline, etc.) Patient who constantly used lutein within 3 months Other subject assessed ineligible by the investigator
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