Age Related Macular DegenerationAMPBL19NCT04779398
Association of MPOD Values With Blue Light.
An observational study of Age Related Macular Degeneration, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy males and females, 18-65 years of age from Brisbane and surroudning areas, Australia.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Human Movement and Nutrition Sciences, The University of Queensland
Saint Lucia, Queensland, 4067
About this study
Official title: Investigating Associations Between Chronic Electronic Device Blue Light Exposure, Dietary Xanthophyll Intake and Macular Pigment Density in Humans.
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:
- Higher usual daily electronic device blue light exposure will be negatively correlated with MPOD value.
- Usual dietary intake of L/Z will be positively correlated with MPOD value.
- L/Z concentration will be positively correlated with MPOD value.
- Usual dietary intake of L/Z will be positively correlated with plasma L/Z concentrations.
- Higher usual intake of L/Z will mitigate the effect of higher electronic device exposure on MPOD value.
Read the detailed description
Exponential uptake of modern technology over the last 30 years (computers) and 10 years (smartphones) has resulted in remarkable increase in artificial blue light exposure amongst all age groups. This suggests the incidence of age-related macular degeneration (AMD) could be increasing significantly in the population in the years to come. It is unknown whether the extent of daily blue light exposure influences macular pigment optical density (MPOD) in young to middle age adults. Stringham et al. (2017) showed that, in 18-25 year old healthy adults, exposed to electronic devices over 6 hours daily, MPOD value and visual performance significantly improved after 6 months of lutein/zeaxanthin/meso-zeaxanthin supplementation. The findings of this project may inform on the risks of high exposure to electronic screens and the need to address with preventive measures the potential decline in MPOD and increased risk of AMD. The impact of usual dietary intake of macular xanthophylls on circulating concentrations and MPOD will be investigated. Findings may inform guidelines on recommended daily intake of these food constituents either through diet or supplementation.
Data Management and Confidentiality of Data Collected:
Consent is sought for extended use of the collected data which means it may be used in future research. For example, in the future if more sensitive methods for detecting L/Z, or other macular pigments become available, stored blood samples may be re-analysed. Furthermore, data may be used for subsequent statistical analysis and statistical analysis may be published in peer-reviewed journals, however no identifiable personal details will be published or used. Any personal information, such as full name and date of birth will remain confidential to only the study investigators at all times.
All hard copy personal information and measures taken as part of the study protocol will be stored in locked filing cabinets when not in use, and will only be accessible to approved study investigators. Any electronic data collected for the study will be stored using the UQ Research Data Management system. Data will be de-identified through the use of participant ID numbers allocated at enrolment. Re-identification of participant information will only be accessible by study investigators. At the conclusion of the study, participant hard copy files and trial documents are kept in locked filing cabinets for a period of 15 years. After this time, records will be disposed of by a certified record destruction, such as shredding.
Blood samples will be collected for research purposes, specifically for the measurement of plasma lutein and zeaxanthin concentrations. Collected samples will be stored as per the extended consent sought, held for up to 15 years. After this time, they will be destroyed via incineration. Collected plasma samples will only be identifiable via the participant study number allocated at enrolment. All publicly shared data or data used in publications will be in a non-identifiable form.
Data recorded and maintained for this trial will be controlled in accordance with the national Privacy Principles and Privacy Act 1988.
Sample Size:
Sample size calculation was performed on the basis of a MPOD coefficient of variation of 0.187 optical density units (ODU) measured in a sample of 5581 adults using the Macular Pigment Screener II (18). A minimum of 105 participants was calculated using a two tailed, random model, linear multiple regression with an alpha error probability: 0.05, power: 0.90, number of predictors: 4. This also allows for a 20% drop out rate.
Statistical Tests:
Analysis will be conducted using GraphPad Prism 8. Participants will be stratified by MPOD.
- Descriptive statistics will be performed.
- All data will be tested for normality of distribution using the D'Agostino-Pearson normality test.
- Based on the outcome of testing for normality of distribution, Spearman or Pearson's correlations will be used to test for correlation between the following variables.
- MPOD and daily hours of electronic device use.
- MPOD and usual dietary intake of lutein and zeaxanthin (L/Z).
- MPOD and serum L/Z concentration.
- Serum L/Z concentration and usual dietary intake of L/Z.
- Multiple linear regression will be used to test for correlation to MPOD with the following variables:
- Daily hours of electronic device use.
- Usual dietary intake of L/Z.
- Age
- Gender
Results will be considered statistically significant if p<0.05.
- Conditions
- Age Related Macular Degeneration
- Keywords
- macular pigment optical density, lutein, zeaxanthin, dietary intake, blue light
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Pigment Optical Density
Machine: Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry.
Measured: Triplicate measurement day 1
Secondary outcomes (3)
Dietary intake of lutein and zeaxanthin
Daily intake of lutein and zeaxanthin (mg/day) measured by food frequency questionnaire.
Measured: Retrospective intake prior one month
Usual use of electronic devices.
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.
Measured: Retrospective use of devices prior 3 months.
Blood lutein and zeaxanthin concentration
Single sample of plasma to measure concentration of lutein and zeaxanthin by high performance liquid chromatography and photodiode array detection.
Measured: Single sample drawn on day of study visit (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start25 Sep 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique Chachay, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779398
- Sponsor's protocol ID
- 2019002736
- Acronym
- AMPBL19
- Status last verified
- May 2022
- First submitted
- 24 Jan 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24792100Wu 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.
PubMed 16950247Algvere 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.
PubMed 16445433Widomska 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.
PubMed 24883226Stringham 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.
PubMed 28661438Williams 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.
PubMed 31061427van 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.
PubMed 19236582
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Associations Between Chronic Electronic Device Blue Light Exposure, Dietary Xanthophyll Intake and Macular Pigment Density in Humans.
- ClinicalTrials.gov ID
- NCT04779398
- Acronym / sponsor ID
- AMPBL19 / 2019002736
- Conditions
- Age Related Macular Degeneration
- Keywords
- macular pigment optical density, lutein, zeaxanthin, dietary intake, blue light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Higher usual daily electronic device blue light exposure will be negatively correlated with MPOD value.
- Usual dietary intake of L/Z will be positively correlated with MPOD value.
- L/Z concentration will be positively correlated with MPOD value.
- Usual dietary intake of L/Z will be positively correlated with plasma L/Z concentrations.
- Higher usual intake of L/Z will mitigate the effect of higher electronic device exposure on MPOD value.
Detailed description
Exponential uptake of modern technology over the last 30 years (computers) and 10 years (smartphones) has resulted in remarkable increase in artificial blue light exposure amongst all age groups. This suggests the incidence of age-related macular degeneration (AMD) could be increasing significantly in the population in the years to come. It is unknown whether the extent of daily blue light exposure influences macular pigment optical density (MPOD) in young to middle age adults. Stringham et al. (2017) showed that, in 18-25 year old healthy adults, exposed to electronic devices over 6 hours daily, MPOD value and visual performance significantly improved after 6 months of lutein/zeaxanthin/meso-zeaxanthin supplementation. The findings of this project may inform on the risks of high exposure to electronic screens and the need to address with preventive measures the potential decline in MPOD and increased risk of AMD. The impact of usual dietary intake of macular xanthophylls on circulating concentrations and MPOD will be investigated. Findings may inform guidelines on recommended daily intake of these food constituents either through diet or supplementation.
Data Management and Confidentiality of Data Collected:
Consent is sought for extended use of the collected data which means it may be used in future research. For example, in the future if more sensitive methods for detecting L/Z, or other macular pigments become available, stored blood samples may be re-analysed. Furthermore, data may be used for subsequent statistical analysis and statistical analysis may be published in peer-reviewed journals, however no identifiable personal details will be published or used. Any personal information, such as full name and date of birth will remain confidential to only the study investigators at all times.
All hard copy personal information and measures taken as part of the study protocol will be stored in locked filing cabinets when not in use, and will only be accessible to approved study investigators. Any electronic data collected for the study will be stored using the UQ Research Data Management system. Data will be de-identified through the use of participant ID numbers allocated at enrolment. Re-identification of participant information will only be accessible by study investigators. At the conclusion of the study, participant hard copy files and trial documents are kept in locked filing cabinets for a period of 15 years. After this time, records will be disposed of by a certified record destruction, such as shredding.
Blood samples will be collected for research purposes, specifically for the measurement of plasma lutein and zeaxanthin concentrations. Collected samples will be stored as per the extended consent sought, held for up to 15 years. After this time, they will be destroyed via incineration. Collected plasma samples will only be identifiable via the participant study number allocated at enrolment. All publicly shared data or data used in publications will be in a non-identifiable form.
Data recorded and maintained for this trial will be controlled in accordance with the national Privacy Principles and Privacy Act 1988.
Sample Size:
Sample size calculation was performed on the basis of a MPOD coefficient of variation of 0.187 optical density units (ODU) measured in a sample of 5581 adults using the Macular Pigment Screener II (18). A minimum of 105 participants was calculated using a two tailed, random model, linear multiple regression with an alpha error probability: 0.05, power: 0.90, number of predictors: 4. This also allows for a 20% drop out rate.
Statistical Tests:
Analysis will be conducted using GraphPad Prism 8. Participants will be stratified by MPOD.
- Descriptive statistics will be performed.
- All data will be tested for normality of distribution using the D'Agostino-Pearson normality test.
- Based on the outcome of testing for normality of distribution, Spearman or Pearson's correlations will be used to test for correlation between the following variables.
- MPOD and daily hours of electronic device use.
- MPOD and usual dietary intake of lutein and zeaxanthin (L/Z).
- MPOD and serum L/Z concentration.
- Serum L/Z concentration and usual dietary intake of L/Z.
- Multiple linear regression will be used to test for correlation to MPOD with the following variables:
- Daily hours of electronic device use.
- Usual dietary intake of L/Z.
- Age
- Gender
Results will be considered statistically significant if p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy males and females, 18-65 years of age from Brisbane and surroudning areas, Australia.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Macular Pigment Optical Density
Time frame: Triplicate measurement day 1
Machine: Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry.
3 secondary outcomes
Dietary intake of lutein and zeaxanthin
Time frame: Retrospective intake prior one month
Usual use of electronic devices.
Time frame: Retrospective use of devices prior 3 months.
Blood lutein and zeaxanthin concentration
Time frame: Single sample drawn on day of study visit (Day 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 24792100Chiu 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.
- Background: PubMed 16950247Wu 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.
- Background: PubMed 16445433Algvere 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.
- Background: PubMed 24883226Widomska 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.
- Background: PubMed 28661438Stringham 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.
- Background: PubMed 31061427Williams 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.
- Background: PubMed 19236582van 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.
- Recruitment page with introductory information about study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Chachay, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular Pigment Optical Density (time frame: Triplicate measurement day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779398, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.