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Efficacy and Safety of Highly Aspheric Lenslets Combined with Diffusion optics technology spectacle Lenses in Slowing Myopia Progression in Children: A Randomized, Single-Blind, Controlled Clinical Trial

Efficacy and Safety of Highly Aspheric Lenslets Combined with Diffusion optics technology spectacle Lenses in Slowing Myopia Progression in Children: A Randomized, Single-Blind, Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110000
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-04
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Myopia

Interventions

highly aspherical lenslets group:Wear highly aspherical lenslets glasses for no less than 12 hours a day.
diffusion optics technology group:Wear diffusion optics technology glasses for no less than 12 hours a day
highly aspherical lenslets combined with diffusion optics technology group:Wear highly aspherical lenslets combined with diffusion optics technology glasses for no less than 12 hours a day

Sponsors

Sichuan Provincial maternity and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1.6-16 years old, gender not limited; 2. The spherical equivalent of myopia is -0.75D to -5.00D, astigmatism is >=-1.50D, anisometropia is = 1.0, and strabismus is <= 15?. 3. No organic eye disease, intraocular pressure 10-21 mmHg; 4. Good cognition and able to cooperate with the examination; 5.Be able to agree to and participate in follow-up studies; 6.Both the guardian and the child themselves are willing to participate in this study and the guardian has signed the informed consent form

Exclusion criteria

Exclusion criteria: 1.Previously used myopia prevention and control products, including functional optical lenses, progressive multifocal lenses, multifocal soft lenses, orthokeratology lenses, low-concentration atropine, light feeding devices, traditional Chinese medicine myopia prevention and control, visual function training, etc. 2.There is dominant strabismus, amblyopia or other eye diseases that affect visual function; 3.There are systemic diseases or medications that may affect eye physiology and refractive development; 4. A history of previous ocular surgeries or ocular trauma that affected the refractive state of the eyes.

Design outcomes

Primary

MeasureTime frame
Axial length;Spherical equivalent";

Countries

China

Contacts

Public ContactChen Xinhua

Sichuan Provincial maternity and Child Health Care Hospital

270961540@qq.com+86 181 8190 7407

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026