Lutein and high myopia

JRCT ID: jRCTs031180168

Registered date:01/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: high myopia
• Date of first enrollment: 18/05/2018
• Target sample size: 44
• Study type: Interventional

Intervention(s)

Lutein group: Oral administration 1 capsule per day for 6 months
Placebo group: Oral administration 1 capsule per day for 6 months

Outcome(s)

• Primary Outcome: Change rate of the macula pigment density
• Secondary Outcome: Change of visual acuity, contrast sensitivity, electron retinal graphy (ERG)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yoshida Takeshi
• Secondary Sponsor: Santen Pharmaceutical Co., Ltd
• Secondary ID(s): UMIN000025635