Condition category
Eye Diseases
Date applied
22/06/2017
Date assigned
27/06/2017
Last edited
26/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Chonnam National University Hospital Biomedical Research Institute

Sponsor details

Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
501757
Korea
South

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes