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Longitudinal Measurements of Visual Diet in Children (VEET)

9 de junho de 2026 atualizado por: Xiaoying Zhu, OD, PhD, MD, MS, FAAO, State University of New York College of Optometry

Myopia is a leading cause of visual impairment worldwide, with prevalence rising rapidly among children. Growing evidence suggests that environmental and behavioral factors play a dominant role in ocular growth; however, current studies typically isolate single components of the visual environment, such as near work or light intensity, limiting investigators' understanding of how multiple visual stimuli interact within individuals over time. The retina is continuously exposed to a dynamic "visual diet," encompassing viewing distance, illuminance, spectral composition of light, and temporal viewing patterns, as well as associated visuomotor responses such as eye vergence and pupil dynamics. A critical barrier to myopia prevention is the lack of longitudinal, quantitative measurements that integrate these factors in real-world settings during childhood ocular development.

The long-term goal of this project is to prevent myopia onset and slow myopia progression through individualized, patient-centered monitoring and modification of the visual diet. The overall objective of this proposal is to longitudinally characterize visual diet and visuomotor behavior in children and to identify the most influential environmental and physiological factors driving myopia onset and progression. The investigators will conduct a 3-year longitudinal observational study enrolling 60 children aged 7-12 years, including myopic children and non-myopic children stratified by risk of myopia progression.

Visão geral do estudo

Descrição detalhada

Visual stimulation plays a critical role in guiding eye growth through activity dependent mechanisms. To date, this visual stimulation or visual diet has been investigated by measuring isolated components including near work, light intensity, or wavelength across different individuals. However, this approach does not address how multiple components of the visual diet interact in the visual development of each individual child. Knowledge gap: There is an urgent need for longitudinal measurements from individual children that incorporate multiple components of the visual environment and visual function as the eye grows and develops. This proposal addresses this gap by measuring longitudinally children's visual diet using a combination of techniques that will record these multiple components with VEET (Visual Environment Evaluation Tool, Meta Reality labs), modern eye tracking, refraction, and biometry. The understanding of the interactions between the visual environment and visual function will allow us to develop more effective approaches for myopia prevention and control.

One major reason that visual diets remain under-investigated is the lack of appropriate technology. The investigators propose to use the novel VEET to measure spectral irradiance, illuminance, viewing distance, and head motion. In addition, the investigators propose to use modern wearable eye tracking to quantify visuomotor response during reading. The investigators' long-term goal is to prevent myopia onset and slow myopia progression in children through an individualized, patient-centered approach that monitors and modifies the visual diet. The specific objective of this proposal is to identify what individual features of the visual diet have the strongest impact on myopia development, and provide specific guidelines to monitor and modify them accordingly in an individualized manner.

Tipo de estudo

Observacional

Inscrição (Estimado)

60

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.

Contato de estudo

  • Nome: Xiaoying Zhu, OD, PhD, MD, MS, FAAO
  • Número de telefone: 212-838-5541
  • E-mail: xzhu@sunyopt.edu

Estude backup de contato

  • Nome: Jingyun Wang, PhD, FAAO
  • Número de telefone: 212-938-5759
  • E-mail: jwang@sunyopt.edu

Locais de estudo

    • New York
      • New York, New York, Estados Unidos, 10036
        • Recrutamento
        • SUNY College of Optometry
        • Contato:

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

  • Filho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra de Probabilidade

População do estudo

Participants will be selected from the Pediatric Clinic at the College and from the local community.

Descrição

Inclusion Criteria:

  • Age: 7-12 years old (inclusive)
  • Astigmatism of < 1.50D
  • Stereopsis equal or better 100 seconds of arc
  • Normal binocular functions.

In addition, for the Myopic group:

- Cycloplegic autorefraction (spherical equivalent, SEQ) between -0.50D and -6.00D, who are not currently pursuing nor intending to start myopia control at the time of enrollment.

For the non-myopic group:

- SEQ between plano and +2.50D.

Exclusion Criteria for both groups:

  • History of refractive surgery or myopia control
  • Binocular abnormalities
  • Ocular and systemic pathologies
  • Developmental delay
  • Unable to wear the VEET at home for 8 days every 6 months for 3 years
  • Pre-term birth (< 34 weeks of gestational age).

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

Coortes e Intervenções

Grupo / Coorte
Myopic group
Children with myopia
Control
Children without myopia

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Refractive error (D)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Measured with an autorefractor
From enrollment to the end of the 3-year study, every 6 months
Axial length (mm)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Measured with a biometer
From enrollment to the end of the 3-year study, every 6 months
Viewing distance (cm)
Prazo: From enrollment to the end of the 3-year study, every 6 months

Measured using the Visual Environment Evaluation Tool (VEET). VEET contains multiple time-of-flight (ToF) infrared sensors embedded in the temple arms of the glasses.The sensors emit infrared light toward objects in front of the wearer.

The device measures the time required for the reflected infrared light to return to the sensor. Using the speed of light, the system calculates the distance between the eye/glasses and the viewed object.

From enrollment to the end of the 3-year study, every 6 months
Illuminance (lux)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Measured with the Visual Environment Evaluation Tool (VEET). VEET uses photometric light sensors that detect the light intensity. The sensors convert incoming light into electrical signals proportional to brightness, and the device reports illuminance in lux, the standard unit for light exposure.
From enrollment to the end of the 3-year study, every 6 months
Wavelength of the environmental light (nm)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Measured with the Visual Environment Evaluation Tool (VEET). The VEET measures light wavelength using integrated spectral light sensors that analyze the composition of incoming light across different portions of the visible spectrum. Rather than only measuring brightness (illuminance), the device also characterizes the spectral distribution of light reaching the wearer.
From enrollment to the end of the 3-year study, every 6 months
Eye vergence (degree)
Prazo: From enrollment to the end of the 3-year study, every 6 months

Using an eye tracker (Pupil Labs). Pupil Labs eye trackers measure eye vergence by tracking the gaze direction of both eyes separately and then calculating the angle between the two visual axes.

Vergence refers to the inward or outward rotation of the eyes when focusing at different viewing distances:

Convergence → eyes rotate inward for near targets Divergence → eyes rotate outward for distant targets

Pupil Labs estimates vergence using these steps:

  1. Track each eye independently
  2. Estimate each eye's gaze vector in 3D
  3. Compute where the two gaze vectors intersect
  4. Calculate the vergence angle between them
From enrollment to the end of the 3-year study, every 6 months
Pupil size (mm)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Using an eye tracker (Pupil Labs). Eye trackers measure pupil size using infrared video imaging and computer vision algorithms that detect the pupil boundary in images captured by eye-facing cameras. The eye tracker shines infrared (IR) light onto the eye using tiny IR LEDs. Infrared light is invisible to the user and produces stable illumination conditions for imaging the pupil. Small cameras pointed at the eyes continuously record high-speed grayscale images of the eye. The pupil appears darker than surrounding structures when using the "dark pupil" technique commonly used in wearable eye trackers. Finally, computer vision algorithms analyze each frame to locate the pupil region, identify the pupil edge, and fit a geometric shape to detect the pupil size in mm.
From enrollment to the end of the 3-year study, every 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Height (cm)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Using a stadiometer.
From enrollment to the end of the 3-year study, every 6 months
Arm length (cm)
Prazo: From enrollment to the end of the 3-year study, every 6 months
Measured using a tape measure.
From enrollment to the end of the 3-year study, every 6 months
Accommodative facility
Prazo: From enrollment to the end of the 3-year study, every 6 months
Using +/- 2.00 D flippers
From enrollment to the end of the 3-year study, every 6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Xiaoying Zhu, OD, PhD, MD, MS, FAAO, State University of New York College of Optometry

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 (Estimado)

8 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2031

Conclusão do estudo (Estimado)

1 de junho de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRBNET ID 2300010
  • Pending (Número de outro subsídio/financiamento: American Acedemy of Optometry Foundation (AAOF))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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