The influences of smartphone use on the status of the tear film and the ocular surface

ISRCTN	ISRCTN17257070
DOI	https://doi.org/10.1186/ISRCTN17257070
Secondary identifying numbers	CNUH-2016-299

Submission date: 22/06/2017
Registration date: 27/06/2017
Last edited: 11/07/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Kyung Chul Yoon
Scientific

Department of Ophthalmology
Chonnam National University Medical School and Hospital
42 Jebong-ro
Dong-gu
Gwangju
61469
Korea, South

ORCID ID	0000-0001-8664-0639

Study information

Study design	Prospective observational clinical study
Primary study design	Observational
Secondary study design	Case series
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The influences of smartphone use on ocular symptoms, status of the tear film, and oxidative stress in the ocular surface
Study objectives	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(s)	Institutional Review Board of Chonnam National University Hospital, 18/11/2016, ref: CNUH-2016-299
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	18/11/2016
Completion date	28/03/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	50
Total final enrolment	80
Key inclusion criteria	1. Healthy adults without other ocular or systemic diseases which could affect ocular condition, or surgical history 2. Over 20 years old
Key exclusion criteria	1. Subjects who used any eye drops 2. Pregnant at the time of the study
Date of first enrolment	20/11/2016
Date of final enrolment	20/12/2016

Locations

Countries of recruitment

Korea, South

Study participating centre

Chonnam National University Hospital

61469
Korea, South

Sponsor information

Chonnam National University Hospital Biomedical Research Institute
Hospital/treatment centre

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

"ROR"	https://ror.org/00f200z37

Funders

Funder type

Hospital/treatment centre

Chonnam National University Hospital Biomedical Research Institute

No information available

Results and Publications

Intention to publish date	28/03/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		31/10/2018	26/11/2021	Yes	No
Protocol file	version 1.2		11/07/2023	No	No

Additional files

ISRCTN17257070_Protocol.pdf

Editorial Notes

11/07/2023: Uploaded protocol (not peer reviewed).
26/11/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.