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临床试验/NCT04779398
NCT04779398已完成不适用

Investigating Associations Between Chronic Electronic Device Blue Light Exposure, Dietary Xanthophyll Intake and Macular Pigment Density in Humans.

The University of Queensland1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Macular Pigment Optical Density

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Macular Pigment Optical Density

时间窗: Triplicate measurement day 1

Machine: Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry.

次要结局

  • Dietary intake of lutein and zeaxanthin(Retrospective intake prior one month)
  • Usual use of electronic devices.(Retrospective use of devices prior 3 months.)
  • Blood lutein and zeaxanthin concentration(Single sample drawn on day of study visit (Day 1).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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