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NCT Number: NCT06821074

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing New Vision Eye Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Defocus-enhanced spectacles

Device

Vision function training while wearing defocus-enhanced spectacles

Single vision spectacles

Device

Vision function training while wearing single vision spectacles

Primary outcomes

  1. 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.

    Change in spherical equivalent 12 months after the commencement of training.

Secondary outcomes

  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.

    Change in axial length 12 months after the commencement of training.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Beijing Visionly Plus Eye Hospital

Other

Collaborators

  • Beijing New Vision Eye Hospital
  • High Myopia Control Alliance (HIMALAYA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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