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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06821074

Enrollment

1000

Registered

2025-02-11

Start date

2025-02-08

Completion date

2027-02-28

Last updated

2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

myopia, Visual Function Training, Defocus-Enhanced Spectacles, Single Vision Spectacles

Brief summary

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

DEVICEDefocus-enhanced spectacles

Vision function training while wearing defocus-enhanced spectacles

DEVICESingle vision spectacles

Vision function training while wearing single vision spectacles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in spherical equivalent 12 months after the commencement of training.	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

Measure	Time frame	Description
Change in axial length 12 months after the commencement of training.	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.

Countries

China

Contacts

Primary ContactLin Yang, M.D.

roc001cn@gmail.com+86-17898805125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026