Effect of Lutemax 2020 on blue light and visual health markers

Not Applicable

Completed

• Conditions: Eye damage; Eye Diseases

• Registration Number: ISRCTN16156382
• Lead Sponsor: OmniActive Health Technologies Inc.

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28661438 2018 results in: https://biomedres.us/pdfs/BJSTR.MS.ID.001250.pdf 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31425700 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-03
• Study Start: 2016-04-22
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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