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Search / Trial NCT07042022

Digital Defocus Vision Training (DDVT) System Development and Application

Launched by ZHONGSHAN OPHTHALMIC CENTER, SUN YAT-SEN UNIVERSITY · Jun 18, 2025

Trial Information

Current as of November 06, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study is testing a new Digital Defocus Vision Training (DDVT) system, delivered through a head‑mounted VR device, to see if it can help prevent or slow myopia (nearsightedness) in children. About 120 kids, ages 6 to 12 with mild to moderate myopia (-0.75 to -6.00 diopters) and meeting other eye health criteria, will be randomly assigned to either receive 10 minutes of DDVT twice daily for six months or to a control group that does not get the DDVT intervention (they still wear full-corrected glasses). The main thing researchers will look at is how much the eye grows over the first year, which is linked to myopia progression. Secondary checks include changes in refractive error and how well the eyes focus and relax, along with some safety monitoring.

The trial is taking place at two sites in China (Guangzhou and Beijing) and is supported by Zhongshan Ophthalmic Center, Sun Yat-sen University. It is still enrolling by invitation, and if you’re eligible you would be randomly placed into either the DDVT group or the control group. The study started in 2024 and aims to complete primary results by late 2025, with overall completion around 2026; results are not yet available.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • children aged 6 to 12 years
  • diagnosis of myopia with SER of -0.75 to -6.00 D
  • regular astigmatism, and astigmatism less than 2.50D
  • anisometropia less than 1.50 D
  • a logMAR best-corrected visual acuity (BCVA) of 0.00 or better
  • an understanding by participants and their legal guardians of the purpose of the study
  • Exclusion Criteria:
  • other myopia control therapies in the last 6 months (including but not limited to atropine and orthokeratology)
  • strabismus, amblyopia, congenital lens dislocation, congenital cataract, glaucoma, uveitis, nystagmus, keratoconus, eye neoplasms and other ocular diseases
  • systemic diseases such as nephrotic syndrome or diabetes
  • structural changes in the eyeball, a history of ocular surgery or trauma
  • other systemic diseases affecting eye health
  • participants in other clinical trials at the same time.

About Zhongshan Ophthalmic Center, Sun Yat Sen University

The Zhongshan Ophthalmic Center, affiliated with Sun Yat-sen University, is a leading institution in ophthalmic research and clinical care in China. Renowned for its commitment to advancing the field of ophthalmology, the center specializes in innovative treatments and technologies for various eye conditions. With a strong emphasis on clinical trials, the center aims to enhance patient outcomes through rigorous scientific investigation and collaboration with global research networks. Its multidisciplinary team of experts is dedicated to fostering cutting-edge research that translates into effective therapeutic strategies for vision preservation and restoration.

Locations

Beijing, China

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported