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

Beijing Visionly Plus Eye Hospital

Status: Enrolling

Conditions: Myopia

Treatments: Device: Single vision spectacles; Device: Defocus-enhanced spectacles

Study type: Interventional

Funder types: Other

Identifiers

NCT06821074

Himalaya202502

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups, including a placebo group

Defocus-enhanced spectacles

Experimental group

Description:

Vision function training while wearing defocus-enhanced spectacles

Single vision spectacles

Placebo Comparator group

Description:

Vision function training while wearing single vision spectacles

Treatment:

Device: Single vision spectacles