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

5 de agosto de 2021 atualizado por: National Cheng-Kung University Hospital

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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Tainan, Taiwan
        • National Cheng Kung University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: LED screen
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Lipid Layer Thickness
Prazo: Change from baseline lipid layer thickness at 15 minutes
Change from baseline lipid layer thickness at 15 minutes

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual Acuity
Prazo: Change from baseline visual acuity at 15 minutes
Change from baseline visual acuity at 15 minutes
Intraocular Pressure
Prazo: Change from baseline intraocular pressure at 15 minutes
Change from baseline intraocular pressure at 15 minutes
Blink rates
Prazo: Change from baseline blink rates at 15 minutes
Change from baseline blink rates at 15 minutes
Computer Vision Syndrome Questionnaire Score
Prazo: Change from Baseline Computer Vision Syndrome Questionnaire Score at 15 minutes
The Computer Vision Syndrome Questionnaire is a validated questionnaire to assess the severity of the computer vision syndrome.
Change from Baseline Computer Vision Syndrome Questionnaire Score at 15 minutes

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Yi-Hsun Huang, PhD, National Cheng-Kung University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2020

Conclusão Primária (Real)

22 de agosto de 2020

Conclusão do estudo (Real)

22 de agosto de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

29 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2021

Primeira postagem (Real)

12 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de agosto de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

The informed consent of this study specified that the participants' data would only be used in this study

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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