age-related macular degeneration (AMD) patients
Conditions
Interventions
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 onc
Sponsors
Raman Study Team
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients having either early age-related maculopathy (ARM), exudative age-related macular degeneration (AMD), or atrophic AMD (2) Patients showing either visual acuity of less than 1.0, decreased contrast sensitivity, metamorphopsia detected by M-cahrt, or decreased perimetric mean sensitivity measured by Humphry visual field analyzer (program 10-2) (3) Patients aged 50-year-old or more and can sign an informed consent form for participation of this study (4) Patients whom the principal investigator judges competent (5) Patients with no lutein allergy
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements of visual acuity, contrast sensitivity, metamorphopsia graded by M-chart, perimetric mean sensitivity, and macular pigment density | — |
Countries
Japan
Contacts
Public ContactAkira Obana, MD, PhD
Seirei Hamamatsu General Hospital Department of Ophthalmology
Outcome results
None listed