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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04779398
Registration number
NCT04779398
Ethics application status
Date submitted
24/01/2021
Date registered
3/03/2021
Titles & IDs
Public title
Association of MPOD Values With Blue Light.
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Scientific title
Investigating Associations Between Chronic Electronic Device Blue Light Exposure, Dietary Xanthophyll Intake and Macular Pigment Density in Humans.
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Secondary ID [1]
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2019002736
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Universal Trial Number (UTN)
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Trial acronym
AMPBL19
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Macular Pigment Optical Density
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Assessment method [1]
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Machine: Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry.
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Timepoint [1]
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Triplicate measurement day 1
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Secondary outcome [1]
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Dietary intake of lutein and zeaxanthin
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Assessment method [1]
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Daily intake of lutein and zeaxanthin (mg/day) measured by food frequency questionnaire.
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Timepoint [1]
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Retrospective intake prior one month
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Secondary outcome [2]
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Usual use of electronic devices.
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Assessment method [2]
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Capturing exposure to blue light from electronic devices through questionnaire that asks participants to record usual hours of device use each day over last 3 months.
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Timepoint [2]
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Retrospective use of devices prior 3 months.
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Secondary outcome [3]
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Blood lutein and zeaxanthin concentration
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Assessment method [3]
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Single sample of plasma to measure concentration of lutein and zeaxanthin by high performance liquid chromatography and photodiode array detection.
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Timepoint [3]
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Single sample drawn on day of study visit (Day 1).
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Eligibility
Key inclusion criteria
* Male and females 18 to 65 years.
* Generally healthy.
* No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
* Non-smoker
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
* Participant reported diagnosis, or current treatment of age-related macular degeneration.
* Participant reported diagnosis of epilepsy.
* Current or past smoker (within last 12 months).
* Under 18 or over 65 years of age.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2022
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Sample size
Target
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Accrual to date
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Final
96
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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School of Human Movement and Nutrition Sciences, The University of Queensland - Saint Lucia
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Recruitment postcode(s) [1]
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4067 - Saint Lucia
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to investigate in healthy adults 18-65 years of age the association of electronic device blue light exposure and macular pigment optical density (MPOD) considering usual dietary intake of lutein and zeaxanthin (L/Z) as confirmed by serum lutein and zeaxanthin concentrations. It is hypothesised in healthy adults 18-65 years of age: 1. Higher usual daily electronic device blue light exposure will be negatively correlated with MPOD value. 2. Usual dietary intake of L/Z will be positively correlated with MPOD value. 3. L/Z concentration will be positively correlated with MPOD value. 4. Usual dietary intake of L/Z will be positively correlated with plasma L/Z concentrations. 5. Higher usual intake of L/Z will mitigate the effect of higher electronic device exposure on MPOD value.
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Trial website
https://clinicaltrials.gov/study/NCT04779398
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Trial related presentations / publications
Chiu CJ, Chang ML, Zhang FF, Li T, Gensler G, Schleicher M, Taylor A. The relationship of major American dietary patterns to age-related macular degeneration. Am J Ophthalmol. 2014 Jul;158(1):118-127.e1. doi: 10.1016/j.ajo.2014.04.016. Epub 2014 Apr 29. Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009. Algvere PV, Marshall J, Seregard S. Age-related maculopathy and the impact of blue light hazard. Acta Ophthalmol Scand. 2006 Feb;84(1):4-15. doi: 10.1111/j.1600-0420.2005.00627.x. Widomska J, Subczynski WK. Why has Nature Chosen Lutein and Zeaxanthin to Protect the Retina? J Clin Exp Ophthalmol. 2014 Feb 21;5(1):326. doi: 10.4172/2155-9570.1000326. Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047. Williams R, Bakshi S, Ostrin EJ, Ostrin LA. Continuous Objective Assessment of Near Work. Sci Rep. 2019 May 6;9(1):6901. doi: 10.1038/s41598-019-43408-y. van der Veen RL, Berendschot TT, Hendrikse F, Carden D, Makridaki M, Murray IJ. A new desktop instrument for measuring macular pigment optical density based on a novel technique for setting flicker thresholds. Ophthalmic Physiol Opt. 2009 Mar;29(2):127-37. doi: 10.1111/j.1475-1313.2008.00618.x.
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Public notes
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Contacts
Principal investigator
Name
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Veronique Chachay, PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04779398