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Lipid Tear Deficiency (Disorder)NCT05003128

Changes in Tear Lipid Layer Thickness After Short Exposure to Light Emitting Diode Displays

A study testing LED screen (InnoLux, Taiwan) in people with Lipid Tear Deficiency (Disorder) and Dry Eye Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Video display terminals (VDTs) are ubiquitous, and engagement in digital screens has grown substantially across all age groups worldwide. Prolonged exposure to VDTs is associated with the development of various health problems. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
What is being tested?
LED screen (InnoLux, Taiwan)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Jul 2020to 22 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • generally healthy individuals aged between 20 and 65 years who were willing to participate in the study

Who cannot join

  • ages below 20 or over 65 years
  • a BCVA score of <0.1 on the Landolt C chart in either eye
  • a BCVA difference of >0.2 between the eyes
  • a history of ocular diseases or previous ocular surgery

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Cheng Kung University Hospital

    Tainan

Other trials in Taiwan

About this study

Video display terminals (VDTs) are ubiquitous, and engagement in digital screens has grown substantially across all age groups worldwide. Prolonged exposure to VDTs is associated with the development of various health problems. By now, it is unclear whether transient exposure to VDTs leads to ocular surface changes, especially regarding lipid layer thickness (LLT). This study aim to determine if short-term exposure to light-emitting diodes (LEDs) leads to ocular parameter changes.

This is a prospective, cross-sectional study. Patients were recruited at the National Cheng-Kung University Hospital, a tertiary referral center in southern Taiwan, for examination, including best-corrected visual acuity (BCVA), intraocular pressure (IOP), lipid layer thickness (LLT), and blink rates and patterns before and after watching an LED display for 15 minutes. The estimated result is that the LLT and blink rates will decrease after VDT watching.

Read the detailed description

Video display terminals (VDTs) are ubiquitous, and engagement in digital screens has grown substantially across all age groups worldwide. During the coronavirus disease 2019 (COVID-19) pandemic, lockdowns and increasing demand for digital learning and working have led to more frequent and sustained VDT use. Prolonged exposure to VDTs is associated with the development of various health problems, including psychosocial issues, venous thromboembolism, fatigue, and visual complaints.

Computer vision syndrome (CVS) is one of the most frequently encountered problems among VDT users. CVS comprises several visual and musculoskeletal symptoms resulting from VDT use, such as eye strain, dryness and burning sensation of the eye, blurred vision, and neck and shoulder pain. A major alteration is the development of dry eye disease (DED), occurring in 60 % of those with CVS. Dry eye symptoms, corneal erosions, short tear-film breakup time (BUT), low tear meniscus height, and meibomian gland dysfunction (MGD) are all DED presentations encountered by VDT users. The continuous use of VDTs is an established risk factor for CVS and DED. However, it is unclear whether transient exposure to VDTs leads to ocular surface changes, especially regarding lipid layer thickness (LLT).

This study investigated if the short-term use of light-emitting diode (LED) displays (one type of VDT) changed the ocular parameters, including best-corrected visual acuity (BCVA), intraocular ocular pressure (IOP), the CVS-Questionnaire (CVS-Q) score, the blink rate, the partial blink ratio, and LLT. To our knowledge, this is the first study to focus on the immediate effects of LEDs on the eye.

This prospective clinical study was conducted in the Ophthalmology Department of the National Cheng Kung University Hospital (NCKUH), Tainan, Taiwan. The study was approved by the Institutional Review Board of NCKUH and followed the tenets of the Declaration of Helsinki. Written informed consent was obtained from all the participants.

The inclusion criteria were generally healthy individuals aged between 20 and 65 years who were willing to participate in the study. The exclusion criteria were ages below 20 or over 65 years, a BCVA score of <0.1 on the Landolt C chart in either eye, a BCVA difference of >0.2 between the eyes, and a history of ocular diseases or previous ocular surgery.

Participants were instructed to fill out a basic information form, including their name, sex, age, and contact information. They were also informed to avoid wearing contact lenses for two days before the test. The experiment was conducted on August 22, 2020. For the baseline test, the participants were asked to complete the CVS-Q to assess their CVS. Next was a series of ocular examinations, including BCVA, IOP, LLT, an optical coherence tomography (OCT) scan of the macula, and fundus autofluorescence (FAF) imaging. The LLT and blink rates were measured using the LipiView II Ocular Surface Interferometer following the standard protocol (TearScience, Morrisville, NC, USA). After the examination, the participants watched a short movie on an LED screen (InnoLux, Taiwan) for 15 minutes in a bright room. The viewing distance was approximately 1.5 meters. After the movie ended, the participants were instructed to complete the CVS-Q and undergo the BCVA, IOP, and LLT tests again. The baseline BCVA, IOP, OCT, and FAF images of each participant were reviewed by three NCKUH ophthalmologists to screen for clinically significant ocular pathology.

Statistical analyses were performed using R software version 4.1.0 (R Core Team, Vienna, Austria) and SAS Enterprise Guide (version 9.4; SAS Institute Inc., Cary, NC, USA). Paired t-tests were used to compare the BCVA, IOP, CVS-Q score, LLT, blink rate, and the partial blink ratio before and after watching the LED display. Statistical significance was set at P <0.05.

Being tested
LED screen (InnoLux, Taiwan)
Keywords
Computer vision syndrome, Dry eye disease, Light emitting diode, Lipid layer thickness, Video display terminals
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LED screen (InnoLux, Taiwan)Device

    Participants watch a short movie on an LED screen (InnoLux, Taiwan) for 15 minutes in a bright room. The viewing distance was approximately 1.5 meters.

Study groups in NCT05003128
Study groupRoleWhat they receive
LED screenExperimentalNot described
Receives: Device: LED screen (InnoLux, Taiwan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid Layer Thickness

    Measured: Change from baseline lipid layer thickness at 15 minutes

Secondary outcomes (4)
  1. Visual Acuity

    Measured: Change from baseline visual acuity at 15 minutes

  2. Intraocular Pressure

    Measured: Change from baseline intraocular pressure at 15 minutes

  3. Blink rates

    Measured: Change from baseline blink rates at 15 minutes

  4. Computer Vision Syndrome Questionnaire Score

    The Computer Vision Syndrome Questionnaire is a validated questionnaire to assess the severity of the computer vision syndrome.

    Measured: Change from Baseline Computer Vision Syndrome Questionnaire Score at 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Jul 2020
  3. Primary completion22 Aug 2020
  4. Study completion22 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003128
Sponsor's protocol ID
A-ER-108-489
Status last verified
Jul 2021
First submitted
29 Jul 2021
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The informed consent of this study specified that the participants' data would only be used in this study

Questions about this trial

What is this clinical trial studying?

A study testing LED screen (InnoLux, Taiwan) in people with Lipid Tear Deficiency (Disorder) and Dry Eye Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipid Layer Thickness (time frame: Change from baseline lipid layer thickness at 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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