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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.
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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