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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
Date last updated
19/05/2022

Titles & IDs
Public title
Association of MPOD Values With Blue Light.
Scientific title
Investigating Associations Between Chronic Electronic Device Blue Light Exposure, Dietary Xanthophyll Intake and Macular Pigment Density in Humans.
Secondary ID [1] 0 0
2019002736
Universal Trial Number (UTN)
Trial acronym
AMPBL19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Macular Pigment Optical Density
Timepoint [1] 0 0
Triplicate measurement day 1
Secondary outcome [1] 0 0
Dietary intake of lutein and zeaxanthin
Timepoint [1] 0 0
Retrospective intake prior one month
Secondary outcome [2] 0 0
Usual use of electronic devices.
Timepoint [2] 0 0
Retrospective use of devices prior 3 months.
Secondary outcome [3] 0 0
Blood lutein and zeaxanthin concentration
Timepoint [3] 0 0
Single sample drawn on day of study visit (Day 1).

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2022
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
School of Human Movement and Nutrition Sciences, The University of Queensland - Saint Lucia
Recruitment postcode(s) [1] 0 0
4067 - Saint Lucia

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04779398
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.
Public notes

Contacts
Principal investigator
Name 0 0
Veronique Chachay, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04779398