Efficacy of lutein supplement on macular pigments density and visual performance of age-related macular degeneration (AMD) patients

UMIN ID: UMIN000000635

Registered date:11/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: age-related macular degeneration (AMD) patients
• Date of first enrollment: 2007/03/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

One capsule containing 10 mg of lutein and 0.8 mg of zeaxanthin is administered to each participants once a day for 12 months
One capsule of placebo supplement is administered to each participants once a day for 12 months

Outcome(s)

• Primary Outcome: Measurements of visual acuity, contrast sensitivity, metamorphopsia graded by M-chart, perimetric mean sensitivity, and macular pigment density

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Eyes with cataract that affect the measurement of visual function tests. (2) Eyes received cataract surgery within six months (3) Eyes with glaucoma, diabetic retinopathy and any other eye disease (4) Patient with serious disease in liver, kidney or heart that impacts on the evaluation of the use of lutein supplements (5) Patient who is taking photosensitive medicine, such as phenothiazine, chloroquine or tetracycline (6) Patient who involved in the other clinical trials within three months (7) Others. Patients whom the principal investigator judges incompetent

Related Information

• Primary Sponsor: Raman Study Team
• Secondary Sponsor: None
• Source(s) of Monetary Support: Seirei Hamamatsu General Hospital,Kemin Japan, Koyo Mercantile Co., LTD