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

NCT ID: NCT06821074

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-08

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Defocus-enhanced spectacles

Vision function training while wearing defocus-enhanced spectacles

Group Type EXPERIMENTAL

No interventions assigned to this group

Single vision spectacles

Vision function training while wearing single vision spectacles

Group Type PLACEBO_COMPARATOR

Single vision spectacles

Intervention Type DEVICE

Vision function training while wearing single vision spectacles

Interventions

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Defocus-enhanced spectacles

Vision function training while wearing defocus-enhanced spectacles

Intervention Type DEVICE

Single vision spectacles

Vision function training while wearing single vision spectacles

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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High Myopia Control Alliance (HIMALAYA)

UNKNOWN

Sponsor Role collaborator

Beijing New Vision Eye Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Visionly Plus Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing New Vision Eye Hospital

Beijing, , China

Site Status RECRUITING

Beijing Visionly Plus Eye Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin Yang, M.D.

Role: CONTACT

+86-17898805125

Facility Contacts

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Lin Yang, M.D.

Role: primary

+86-17898805125

Lin Yang, M.D.

Role: primary

+86-17898805125

Other Identifiers

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Himalaya202502

Identifier Type: -

Identifier Source: org_study_id

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