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Longitudinal Measurements of Visual Diet in Children (VEET)

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Xiaoying Zhu, OD, PhD, MD, MS, FAAO
  • Telefonnummer: 212-838-5541
  • E-Mail: xzhu@sunyopt.edu

Studieren Sie die Kontaktsicherung

  • Name: Jingyun Wang, PhD, FAAO
  • Telefonnummer: 212-938-5759
  • E-Mail: jwang@sunyopt.edu

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10036
        • Rekrutierung
        • SUNY College of Optometry
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Myopic group
Children with myopia
Control
Children without myopia

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Refractive error (D)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Height (cm)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

State University of New York College of Optometry

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

8. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2031

Studienabschluss (Geschätzt)

1. Juni 2031

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRBNET ID 2300010
  • Pending (Andere Zuschuss-/Finanzierungsnummer: American Acedemy of Optometry Foundation (AAOF))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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