utein and high myopia

Not Applicable

• Conditions: high myopia

• Registration Number: JPRN-jRCTs031180168
• Lead Sponsor: Yoshida Takeshi

Brief Summary

A comparison of changes in macular pigment density and visual function in Japanese patients with high myopia treated with lutein-containing supplement or placebo for 6 months showed no statistically significant difference between the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Study Completion: 2019-12-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1) At least one eye is high myopia which axial length is between 26.5 mm to 30.0 mm
2) Individuals who do not have allergy to lutein or zeaxanthin

Exclusion Criteria

1) Eyes which pupil diameter during mydriasis is less than 6.5mm
2) Eyes with other serious disease like glaucoma, diabetic retinopathy, age-related macular degeneration
3) Individuals with liver, kidney disease or cardiac disease which affect the evaluation of used supplement
4) Individuals who continuously used a lutein supplement during past 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change rate of the macula pigment density

Secondary Outcome Measures

Name	Time	Method
Change of visual acuity, contrast sensitivity, electron retinal graphy (ERG)