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

Not Applicable

• Conditions: Patients with hemilateral age-related macular degeneration (AMD)

• Registration Number: JPRN-UMIN000007628
• Lead Sponsor: Seirei Hamamatsu General Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-20
• Study Completion: 2015-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
macular pigment density

Secondary Outcome Measures

Name	Time	Method
visual acuity, contrast sensitivity, glare sensitivity, plasma lutein level, OCT retinal thickness at the central fovea