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A Clinical Study Evaluating the Efficacy of Novel Defocus-Dot Diffusion Dual-Effect Design Lenses in Controlling Myopia Progression in Children

A Clinical Study Evaluating the Efficacy of Novel Defocus-Dot Diffusion Dual-Effect Design Lenses in Controlling Myopia Progression in Children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111118
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Myopia

Interventions

Single-Focus Group:Single-focus lenses
Multi-Focal Group:multi-focal lenses
Novel Dual-Effect Group:novel dual-effect lenses

Sponsors

Yantai Yuhuangding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Children and adolescents aged 7 to 15 years (including both age limits). 2. Children and adolescents who have not previously received any myopia correction or treatment and are receiving their first pair of corrective lenses. 3. After cycloplegia, computerized refraction shows bilateral equivalent spherical power: -6.00D = -2.00D. 5. Best-corrected visual acuity in both eyes >= 1.0. 6. Binocular refractive error (equivalent spherical difference) <= 2.00D. 7. Normal ocular examination findings and normal intraocular pressure.

Exclusion criteria

Exclusion criteria: 1. Potential ocular diseases affecting vision or refractive errors (e.g., corneal disorders, cataracts, glaucoma, macular degeneration). 2. Anisometropia (difference in equivalent spherical power between eyes) >2.00D, strabismus, amblyopia. 3. Any pathological ocular changes or systemic diseases. 4. Prior use of myopia control treatments such as atropine, orthokeratology lenses, multifocal soft lenses, multifocal rigid lenses, or functional spectacles. 5. Other reasons deemed ineligible for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
spherical equivalent refraction after ciliary muscle paralysis(SER);axial length(AL);

Secondary

MeasureTime frame
distance lateral phoria(DLP);best corrected visual acuity(BCVA);uncorrected visual acuity(UCVA);negative relative accommodation(NRA);binocular cross-cylinder(BCC);accommodative facility(AF);near lateral phoria(NLP);positive relative accommodation(PRA);negative fusion vergence(NFV);keratometry(K);contrast sensitivity(CS);subfoveal choroidal thickness(SFCT);positive fusion vergence(PFV);amplitude of accommodation(AMP);stereoacuity;

Countries

China

Contacts

Public ContactZhang Fenglan

Yantai Yuhuangding Hospital

zhangfenglan21st@126.com+86 535 6691999

Outcome results

None listed

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