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Longitudinal Measurements of Visual Diet in Children (VEET)

9. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

60

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Xiaoying Zhu, OD, PhD, MD, MS, FAAO
  • Telefonní číslo: 212-838-5541
  • E-mail: xzhu@sunyopt.edu

Studijní záloha kontaktů

  • Jméno: Jingyun Wang, PhD, FAAO
  • Telefonní číslo: 212-938-5759
  • E-mail: jwang@sunyopt.edu

Studijní místa

  • Spojené státy
    • New York
      • New York, New York, Spojené státy, 10036
        • Nábor
        • SUNY College of Optometry
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Myopic group
Children with myopia
Control
Children without myopia

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Refractive error (D)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Height (cm)
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

State University of New York College of Optometry

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

8. června 2026

Primární dokončení (Odhadovaný)

1. června 2031

Dokončení studie (Odhadovaný)

1. června 2031

Termíny zápisu do studia

První předloženo

4. června 2026

První předloženo, které splnilo kritéria kontroly kvality

9. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRBNET ID 2300010
  • Pending (Jiné číslo grantu/financování: American Acedemy of Optometry Foundation (AAOF))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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