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Myopia Control Efficacy in Pre-myopic Children with Spectacle Lenses Filling Defocus-Enhanced Micro-Lenses

Myopia Control Efficacy in Pre-myopic Children with Spectacle Lenses Filling Defocus-Enhanced Micro-Lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110346
Enrollment
Unknown
Registered
2025-10-13
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Myopia

Interventions

Control group:Spectacle lenses with highly aspherical lenslets (HAL)
Experimental group:Defocus enhanced lens (DEL)

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1. Cycloplegic spherical equivalent +0.75 D(including) - -0.50 D(excluding)) : 6-9 years old, at least one parent is myopic -3.00 D or above; 2. Cylinder diopter < 1.00D; Binocular spherical equivalent anisometropia <=1.00D; 3. Monocular uncorrected visual acuity <= 0.1 LogMAR; 4. Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion criteria

Exclusion criteria: 1. Received myopia intervention in the past 3 months, such as other specially designed myopia prevention and control frame lenses; Multifocal soft lens; Bifocal lens, gradient multifocal lens; Orthokeratology lenses; Low concentration atropine; Low intensity red light; 2. Active ocular surface inflammation, combined with other ocular diseases, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus disease, ocular tumors, ocular trauma, overt strabismus; And any eye diseases that affect visual function; 3. Immunocompromised patients with systemic diseases (such as diabetes, Down syndrome, rheumatoid arthritis, psychiatric patients or other diseases considered by researchers to be unsuitable for wearing glasses); 4. History of ocular trauma or intraocular surgery; 5. Failure to follow up regularly; 6. Had a disease that was deemed ineligible by other investigators.

Design outcomes

Primary

MeasureTime frame
Axial length;Cycloplegic autorefraction;

Secondary

MeasureTime frame
Visual comfort questionnaire;

Countries

China

Contacts

Public ContactBao Jinhua

Eye Hospital, Wenzhou Medical University

baojessie@mail.eye.ac.cn+86 137 7776 2827

Outcome results

None listed

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