The effects of using virtual reality devices on the eye
| ISRCTN | ISRCTN48251379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48251379 |
| Secondary identifying numbers | HMD01 |
- Submission date
- 07/02/2021
- Registration date
- 20/02/2021
- Last edited
- 01/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The aim of this study is to investigate the effects of virtual reality (VR) devices on vision, including visual acuity (clarity of vision) and ocular (eye) alignment.
Who can participate?
Healthy volunteers aged 20-39 with good visual acuity (better than 20/20)
What does the study involve?
The participants use a VR device and a smartphone each for 2 hours. Half of the randomly selected participants use VR first, and the remaining participants use smartphones first. Then, the researchers measure several eye parameters and compare them.
What are the possible benefits and risks of participating?
Participants had the benefit of an eye examination by ophthalmologists. Risks include dry eye symptoms and mild neurologic symptoms such as headache.
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?
December 2017 to February 2018
Who is funding the study?
1. National Grant and Hospital grant (Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning (South Korea)
2. Chonnam National University Hospital Biomedical Research Institute (South Korea)
Who is the main contact?
Hwan Heo, MD, PhD
hwanheo@jnu.ac.kr
Contact information
Scientific
42 Jebong-ro
Dong-gu
Gwang ju
61469
Korea, South
 ORCID ID |
0000-0003-2169-8770 |
|---|---|
| Phone | +82 (0)62 220 6743 |
| hwanheo@jnu.ac.kr |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case crossover study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of prolonged use of virtual reality devices on visual parameters |
| Study objectives | Although a few studies have reported that viewing stereoscopic images on 3D devices may induce visual asthenopia such as visual discomfort and fatigue, the effects of using newer types of VR devices for hours have not been investigated. The researchers conducted this study to investigate the effects of using VR devices for 2 hours on visual parameters, including refraction, accommodation, convergence, stereopsis, and ocular alignment, as well as on choroidal thickness and subjective symptoms. |
| Ethics approval(s) | Approved 17/08/2017, Chonnam National University Hospital Institutional Review Board (42 Jebong-ro, Dong-gu, Gwang-ju 61469, South Korea; +82 (0)62-220-5257, 5231; cnuhirb@gmail.com), ref: CNUH-2017-217 |
| Health condition(s) or problem(s) studied | Effects of virtual reality devices on visual parameters |
| Intervention | For the VR experiment, the participants freely play a VR game (Lands End, Ustwo Games, UK) for 2 hours that is graded as “comfortable” on a platform provided by Oculus. Visual parameters including refraction, accommodation, convergence, stereopsis, and ocular alignment and measured choroidal thickness are investigated before and after the use of VR devices or smartphones. Subjective symptoms are assessed using questionnaires. The researchers analyze differences in visual parameters before and after the use of VR devices or smartphones and correlations between baseline visual parameters and those after the use of the devices. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Samsung Gear VR device |
| Primary outcome measure | Visual parameters measured before and after the use of VR devices or smartphones for 2 hours: 1. Refraction and accommodation measured using a binocular open-field refractor (Auto Ref/Keratometer WAM-5500, Grand Seiko Co. Ltd, Hiroshima, Japan) 2. Monocular near-point accommodation (NPA) obtained using Donder’s push-up method. A 20/30 single letter on a fixation stick positioned approximately 50 cm from the subject served as the target, and it was moved gradually closer to the subject at a rate of approximately 5.0 cm/s until the subject noticed the blurring of the target. 3. The near-point of convergence (NPC): the fixation target, the starting point of the examination, and moving velocity of the fixation target were the same as those previously described for the NPA measurement. The first point at which the corneal reflex of the participants began to extend outward was considered the endpoint. 4. Stereopsis measured using a near stereopsis vision test (Stereo Fly SO-001 test; Stereo Optical Co., Chicago, IL, USA). Stereopsis of 2500–1200 s of arc, 800–40 s of arc, and 400–100 s of arc measured using fly photos, graded circle test, and animal test for children, respectively. 5. The presence and magnitude of ocular deviations at far (5 m) and near (33 cm) distances verified using the cover test and alternating cover test with a prism. A standard set of loose plastic prisms was used for all measurements. |
| Secondary outcome measures | Measured before and after the use of VR devices or smartphones for 2 hours: 1. Choroidal thickness measured using the Heidelberg Eye Explorer software (Heidelberg Engineering, Heidelberg, Germany) (Version 1.9.10.0) provided by the instrument manufacturer. The researchers manually selected a new line at the choroid–scleral border (CSB). They retained the automatically defined Bruch’s membrane (BM) line, and the software calculated the vertical distance between the two segmentation lines. The choroidal thickness was defined as the vertical distance between the BM and CSB. 2. Subjective symptoms measured using a questionnaire based on a computer vision syndrome questionnaire, including dry eye symptoms (burning, feeling of a foreign body, excessive blinking, tearing, dryness, tingling, and increased sensitivity to light), visual disturbance (blurred vision, double vision, and difficulty focusing for near vision), and neurological symptoms (headache, dizziness, and nausea). The symptom sensation questionnaire included six identical analog scales (0 = none to 6 = too severe to tolerate), and the subject recorded the magnitude of each symptoms compared relative to that at the baseline |
| Overall study start date | 01/12/2017 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 58 |
| Key inclusion criteria | 1. Volunteers aged 20-39 years 2. 20/20 or better best-corrected visual acuity |
| Key exclusion criteria | Volunteers who have an ophthalmologic disorder, including amblyopia, presbyopia, or corneal or retinal disease and history of ocular surgery |
| Date of first enrolment | 10/12/2017 |
| Date of final enrolment | 30/12/2017 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Dong-gu
Gwang-ju
61469
Korea, South
Sponsor information
Hospital/treatment centre
42 Jebong-ro
Dong-gu
Gwang-ju
61469
Korea, South
| Phone | +82 (0)62 220 6743 |
|---|---|
| imccnuh@cnuh.com | |
| Website | http://eng.cnuh.com/ |
"ROR" |
https://ror.org/00f200z37 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in SCI journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Hwan Heo, MD, PhD (hwanheo@jnu.ac.kr). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 01/03/2021 | No | No |
Additional files
- ISRCTN48251379_PROTOCOL.pdf
- Uploaded 01/03/2021
Editorial Notes
01/03/2021: Uploaded protocol (not peer reviewed).
19/02/2021: Trial's existence confirmed by the Chonnam National University Hospital Institutional Review Board.
