Plain English Summary
Background and study aims
Recently, with the increasing use of smartphones, some studies have reported eye health changes associated with smartphone use. As computer monitor work has an adverse effect on the tear film and the eye surface, smartphone use, which is similar to computer monitor work, is also expected to deteriorate the tear film and the eye surface. There has been no report on symptoms, clinical signs, and inflammation and oxidative stress in the eye surface related to smartphone use in healthy people. The aim of this study is to investigate the effects of smartphone use on eye strain, the tear film, and inflammation and oxidative stress in the eye surface in healthy volunteers.
Who can participate?
Healthy volunteers over 20 years old
What does the study involve?
All measurements are carried out before and 1 and 4 hours after smartphone use. Eye symptoms, eye strain, the tear film, inflammation and oxidative stress in the eye surface are all assessed.
What are the possible benefits and risks of participating?
Participants receive a small financial reward. There are no risks associated with this study.
Where is the study run from?
Chonnam National University Hospital (South Korea)
When is the study starting and how long is it expected to run for?
November 2016 to March 2017
Who is funding the study?
Chonnam National University Hospital Biomedical Research Institute (South Korea)
Who is the main contact?
Dr Kyung Chul Yoon
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kyung Chul Yoon
ORCID ID
http://orcid.org/0000-0001-8664-0639
Contact details
Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
61469
Korea
South
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CNUH-2016-299
Study information
Scientific title
The influences of smartphone use on ocular symptoms, status of the tear film, and oxidative stress in the ocular surface
Acronym
Study hypothesis
As visual display terminal (VDT) work has an adverse effect on the tear film and the ocular surface, smartphone use, that is similar to VDT work, is also expected to deteriorate the tear film and the ocular surface.
Ethics approval
Institutional Review Board of Chonnam National University Hospital, 18/11/2016, ref: CNUH-2016-299
Study design
Prospective observational clinical study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Tear film and the ocular surface
Intervention
All measurements were evaluated at baseline, 1 hour, and 4 hours after smartphone use. Subjective symptoms and asthenopia were evaluated by ocular surface disease index (OSDI), visual analogue scale (VAS), and computer vision syndrome (CVS) score. Fluorescein film break-up time (FBUT), non-invasive break up time (NIBUT), Schirmer score, keratoepitheliopathy (KEP), and tear meniscus height (TMH) were evaluated for status of the tear film. Levels of interleukin (IL)-1β, IL-6, IL-17, tumor necrosis factor (TNF)-α, interferon (IFN)-γ, and macrophage inflammatory protein (MIP)-1β were measured by multiplex immunobead assay in the tear film. Oxidative stress markers including hexanoyl lysine (HEL), 4-hydroxy-2-nonenal (4-HNE), malondialdehyde (MDA), and 8-oxo-2’-deoxyguanosine (8-OHdG) in the tear film were measured by ELISA. Reactive oxygen species (ROS) in the conjunctival epithelium were measured by 2’,7’-dichlorodihydrofluorescein diacetate.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Ocular symptoms and asthenopia, evaluated by ocular surface disease index (OSDI), visual analogue scale (VAS), and computer vision syndrome (CVS) score before and after smartphone use
2. Status of the tear film, evaluated using fluorescein film break-up time (FBUT), non-invasive break up time (NIBUT), Schirmer score, keratoepitheliopathy (KEP), and tear meniscus height (TMH)
All outcomes were measured at baseline, 1 hour, and 4 hours after smartphone use
Secondary outcome measures
1. Levels of interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α, interferon (IFN)-γ, interferon gamma-induced protein 10 (IP-10), and monokine induced by interferon-γ (MIG) measured in the tear film
2. Oxidative stress markers including hexanoyl lysine (HEL), 4-hydroxy-2-nonenal (4-HNE), malondialdehyde (MDA), and 8-oxo-2’-deoxyguanosine (8-OHdG) in the tear film measured by ELISA
All outcomes were measured at baseline, 1 hour, and 4 hours after smartphone use
Overall trial start date
18/11/2016
Overall trial end date
28/03/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy adults without other ocular or systemic diseases which could affect ocular condition, or surgical history
2. Over 20 years old
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Subjects who used any eye drops
2. Pregnant at the time of the study
Recruitment start date
20/11/2016
Recruitment end date
20/12/2016
Locations
Countries of recruitment
Korea, South
Trial participating centre
Chonnam National University Hospital
61469
Funders
Funder type
Hospital/treatment centre
Funder name
Chonnam National University Hospital Biomedical Research Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.
Intention to publish date
28/03/2018
Participant level data
Other
Results - basic reporting
Publication summary