Skip to content

The Impact of Multifocal Myopia Defocus Spectacle Lenses on Myopia Onset in Pre-myopic Children: A Real-world Ambidirectional Cohort Study

The Impact of Multifocal Myopia Defocus Spectacle Lenses on Myopia Onset in Pre-myopic Children: A Real-world Ambidirectional Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114621
Enrollment
Unknown
Registered
2025-12-15
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

myopia

Interventions

Control Group (Non-Wearers):None
Exposure Group (Spectacle Wearers):None

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1.Age: 5-10 years; 2.Spherical equivalent refraction (SER) between +0.75 D (inclusive) and -0.50 D (exclusive) in either eye after cycloplegia, with astigmatism =2 axial length measurements during pre-baseline observation (>=3-month interval), demonstrating annualized axial elongation rate >=0.3 mm/year; 4.Uncorrected distance visual acuity (UDVA) >=4.9 (Snellen) in either eye; 5.Absence of manifest strabismus at distance/near with cover test; 6.Expected completion of >=12-month follow-up OR availability of complete annual visit data (refraction & axial length); Prospective section: 1. Recruit children who meet the above inclusion criteria in the outpatient clinic in real time; 2. After signing informed consent, conduct regular follow-ups and collect refractive and axial length data according to a standardized process.

Exclusion criteria

Exclusion criteria: 1.History of any myopia control intervention (e.g., low-dose atropine, low-intensity red-light therapy); 2.Systemic/physical conditions preventing stable spectacle wear; 3.Psychological/psychiatric disorders posing harm risks during spectacle wear; 4.Inability to adhere to study protocols for reliable measurements; 5.Active ocular diseases affecting refractive development (e.g., retinopathy, cataract, ptosis); 6.Systemic/neurodevelopmental conditions impacting refractive development Concurrent ocular/systemic medications affecting retinal modulation, IOP, or myopia progression;

Design outcomes

Primary

MeasureTime frame
Myopia Incidence;

Secondary

MeasureTime frame
The diopter of ciliary muscle paralysis;Axial growth;

Countries

China

Contacts

Public ContactMeiping Xu

Eye Hospital, Wenzhou Medical University

xmp@eye.ac.cn+86 577 8806 8888

Outcome results

None listed

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