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 |
| Protocol serial number | CNUH-2016-299 |
| Sponsor | Chonnam National University Hospital Biomedical Research Institute |
| Funder | Chonnam National University Hospital Biomedical Research Institute |
- 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
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
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
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational clinical study |
| Secondary study design | Case series |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 28/03/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.2 | 11/07/2023 | No | No |
Additional files
- ISRCTN17257070_Protocol.pdf
- Protocol file
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.
