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

Primary Purpose

Lipid Tear Deficiency (Disorder), Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LED screen (InnoLux, Taiwan)
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lipid Tear Deficiency (Disorder) focused on measuring Computer vision syndrome, Dry eye disease, Light emitting diode, Lipid layer thickness, Video display terminals

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LED screen

Arm Description

Outcomes

Primary Outcome Measures

Lipid Layer Thickness

Secondary Outcome Measures

Visual Acuity
Intraocular Pressure
Blink rates
Computer Vision Syndrome Questionnaire Score
The Computer Vision Syndrome Questionnaire is a validated questionnaire to assess the severity of the computer vision syndrome.

Full Information

First Posted
July 29, 2021
Last Updated
August 5, 2021
Sponsor
National Cheng-Kung University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05003128
Brief Title
Changes in Tear Lipid Layer Thickness After Short Exposure to Light Emitting Diode Displays
Official Title
Changes in Tear Lipid Layer Thickness After Short Exposure to Light Emitting Diode Displays
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
August 22, 2020 (Actual)
Study Completion Date
August 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Tear Deficiency (Disorder), Dry Eye Disease
Keywords
Computer vision syndrome, Dry eye disease, Light emitting diode, Lipid layer thickness, Video display terminals

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LED screen
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LED screen (InnoLux, Taiwan)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipid Layer Thickness
Time Frame
Change from baseline lipid layer thickness at 15 minutes
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
Change from baseline visual acuity at 15 minutes
Title
Intraocular Pressure
Time Frame
Change from baseline intraocular pressure at 15 minutes
Title
Blink rates
Time Frame
Change from baseline blink rates at 15 minutes
Title
Computer Vision Syndrome Questionnaire Score
Description
The Computer Vision Syndrome Questionnaire is a validated questionnaire to assess the severity of the computer vision syndrome.
Time Frame
Change from Baseline Computer Vision Syndrome Questionnaire Score at 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: generally healthy individuals aged between 20 and 65 years who were willing to participate in the study Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Hsun Huang, PhD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The informed consent of this study specified that the participants' data would only be used in this study

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

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