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Longitudinal Measurements of Visual Diet in Children (VEET)

9 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xiaoying Zhu, OD, PhD, MD, MS, FAAO
  • Numero di telefono: 212-838-5541
  • Email: xzhu@sunyopt.edu

Backup dei contatti dello studio

  • Nome: Jingyun Wang, PhD, FAAO
  • Numero di telefono: 212-938-5759
  • Email: jwang@sunyopt.edu

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti, 10036
        • Reclutamento
        • SUNY College of Optometry
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Refractive error (D)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Height (cm)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

State University of New York College of Optometry

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 giugno 2026

Completamento primario (Stimato)

1 giugno 2031

Completamento dello studio (Stimato)

1 giugno 2031

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRBNET ID 2300010
  • Pending (Altro numero di sovvenzione/finanziamento: American Acedemy of Optometry Foundation (AAOF))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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