Recruiting

Observational Study

Sponsor:

State University of New York College of Optometry

Code:

NCT07642999

Conditions

Myopia

Visual Diet

Pupil

Viewing Distance

Illuminance

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07642999

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Jun, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Myopic group

Children with myopia

Control

Children without myopia

Primary outcome measure

  • Refractive error (D) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Axial length (mm) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Viewing distance (cm) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Illuminance (lux) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Wavelength of the environmental light (nm) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Eye vergence (degree) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]
  • Pupil size (mm) [ Time Frame: From enrollment to the end of the 3-year study, every 6 months ]

Central Contacts and Locations

Central contacts

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

212-838-5541xzhu@sunyopt.edu

Jingyun Wang, PhD, FAAO

212-938-5759jwang@sunyopt.edu

Locations

SUNY College of Optometry

Recruiting

New York, New York, United States, 10036

Contacts

More Information

Sponsor

State University of New York College of Optometry

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York College of Optometry on 2026-06-11.