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Recruiting NCT06821074

Defocus-Enhanced vs. Single Vision Spectacles in Myopia Control Visual Function Training

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Defocus-enhanced spectacles, Single vision spectacles.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children

Overview

The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.

Interventions

  • Device Defocus-enhanced spectacles
    Vision function training while wearing defocus-enhanced spectacles
  • Device Single vision spectacles
    Vision function training while wearing single vision spectacles

Primary outcome measures

  • Change in spherical equivalent 12 months after the commencement of training. [Time frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.]
Secondary outcome measures (1)
  • Change in axial length 12 months after the commencement of training. [Time frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.]

Eligibility criteria

Inclusion criteria

  • Aged 6-18 years.
  • Diagnosed myopia with SER between -0.50D and -4.00D.
  • Astigmatism ≤ 2.50DC.
  • Anisometropia < 1.25D.

Exclusion criteria

  • Suspected genetic syndromes (e.g., Stickler, Marfan).
  • Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
  • Myopia progression <0.50D SER in the last year.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Beijing New Vision Eye Hospital — Beijing
  • Beijing Visionly Plus Eye Hospital — Beijing

Identifiers

NCT: NCT06821074 · Himalaya202502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗