Effect of Lutemax 2020 on blue light and visual health markers

Macular carotenoids and blue light: Relationships with visual performance, sleep, health, and quality of life

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16156382

Enrollment

Registered

2016-04-22

Start date

2015-05-16

Completion date

Unknown

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye damage Eye Diseases Eye damage

Interventions

Participants are randomly allocated to one of two study groups. Intervention group: Participants take a capsule of Lutemax 2020, which contains 20 mg Lutein and 4 mg Zeaxanthin isomer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Two-three hours of outside activity per day will be recruited with preference, due to blue light exposure 2. MPOD of subjects =0.69 3. One or more of the following symptoms: 3.1. Accommodative issues (difficulty seeing in the distance after prolonged nearwork) 3.2. Digital eyestrain 3.3. Blurry vision 3.4. Difficulty focusing 3.5. Dry and irritated eyes 3.6. Headaches 3.7. Neck and/or back pain 4. Aged 18 to 25 years

Exclusion criteria

Exclusion criteria: 1. Body Mass Index of 30 or greater 2. Macular pigment optical density (MPOD) of 0.70 or higher 3. Ocular disease or insufficient visual acuity (cut off 20/30 visual acuity) 4. Systemic disease or any chronic disease condition 5. Smokers 6. Current use of psychiatric medication

Design outcomes

Primary

Measure	Time frame
1. Contrast sensitivity is determined using a computer-based, 2-alternative, forced-choice procedure at baseline, 3 and 6 months 2. Glare sensitivity is measured using the disability glare performance task and the photostress recovery performance task at baseline, 3 and 6 months 3. Macular pigment optical density is assessed via heterochromatic flicker photometry at baseline, 3 and 6 months	—

Secondary

Measure	Time frame
1. Psychological stress is measured using the Psychological Stress Measure (PSM-9) and the Brief Symptom Inventory (BSI) at baseline, 3 and 6 months 2. Lutein concentration is measured by High-Performance Liquid Chromatography (HPLC) and Enzyme-linked Immune Sorbent Assay (ELISA) using blood samples at baseline, 3 and 6 months 3. General health status is measured at baseline, 3 and 6 months using the following: 25-item Suboptimal Health Status Questionnaire (SHSQ-25). 3.1. SCL 90-r overall affect assessment 3.2. Beck Depression Inventory 3.3. Beck Anxiety Inventory 3.4. Dietary Questionnaire 3.5. A standard cognitive battery (RBANS-update) 3.6. The Pittsburgh Sleep Quality Index (PSQI) 3.7. A questionnaire on different attributes including frequencies such as head ache, eye strain and eye fatigues will be questioned before and after supplementation	—

Measure

Time frame

1. Psychological stress is measured using the Psychological Stress Measure (PSM-9) and the Brief Symptom Inventory (BSI) at baseline, 3 and 6 months 2. Lutein concentration is measured by High-Performance Liquid Chromatography (HPLC) and Enzyme-linked Immune Sorbent Assay (ELISA) using blood samples at baseline, 3 and 6 months 3. General health status is measured at baseline, 3 and 6 months using the following: 25-item Suboptimal Health Status Questionnaire (SHSQ-25). 3.1. SCL 90-r overall affect assessment 3.2. Beck Depression Inventory 3.3. Beck Anxiety Inventory 3.4. Dietary Questionnaire 3.5. A standard cognitive battery (RBANS-update) 3.6. The Pittsburgh Sleep Quality Index (PSQI) 3.7. A questionnaire on different attributes including frequencies such as head ache, eye strain and eye fatigues will be questioned before and after supplementation

—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026