Longitudinal Measurements of Visual Diet in Children

NCT07642999 | Recruiting

• 2 other identifiers: IRBNET ID 2300010Pending
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Visual Diet; Pupil; Viewing Distance; Illuminance; Wavelength; Vergence; Accommodative Facility

Outcome Measures

Primary Outcomes (7)

• Refractive error (D)

  Measured with an autorefractor

  From enrollment to the end of the 3-year study, every 6 months

• Axial length (mm)

  Measured with a biometer

  From enrollment to the end of the 3-year study, every 6 months

• Viewing distance (cm)

  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)

  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)

  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)

  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)

  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

Secondary Outcomes (3)

• Height (cm)

  From enrollment to the end of the 3-year study, every 6 months

• Arm length (cm)

  From enrollment to the end of the 3-year study, every 6 months

• Accommodative facility

  From enrollment to the end of the 3-year study, every 6 months

Study Arms (2)

Myopic group

Children with myopia

Control

Children without myopia

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• State University of New York College of Optometry: lead

Study Sites (1)

SUNY College of Optometry

New York, New York, 10036, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Xiaoying Zhu, OD, PhD, MD, MS, FAAO

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoying Zhu, OD, PhD, MD, MS, FAAO

CONTACT

212-838-5541; xzhu@sunyopt.edu

Jingyun Wang, PhD, FAAO

CONTACT

212-938-5759; jwang@sunyopt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)