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A multicenter, double-blind, randomized controlled clinical trial for defocused spectacle lenses in controlling progression of high myopia in children

A multicenter, double-blind, randomized controlled clinical trial for defocused spectacle lenses in controlling progression of high myopia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036880
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

High Myopia

Interventions

Defocused spectacle lenses group:wear defocused spectacle lenses
Non-defocused spectacle lenses group:wear non-defocused spectacle lenses

Sponsors

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8 to 14 years old; 2. Any eye been diagnosed as myopia. After cycloplegia, the spherical equivalent is from -8 to -5 diopter, astigmatism =0.5 diopter; 3. The best corrected visual acuity >=0.8, near visual acuity >=1.0, Titmus stereo vision =1500g; 5. Accept random group assignment and blind study design. The guardians and children who are no younger than 12 years old need to assign written informed consent, while children under 12 years old need oral informed consent.

Exclusion criteria

Exclusion criteria: 1. Any ocular or systemic diseases (e.g. Marfan's syndrome, retinopathy of prematurity, etc.) that may affect vision and refractive development; 2. Patients with xerophthalmia, allergic conjunctivitis, entropion, trichiasis, severe keratoconjunctival infection, keratoconus and other eye diseases; 3. Those who have allergies or contraindications to cycloplegia drugs; 4. Those who had received other treatment for myopia control in the last year, such as atropine and other anticholinergic drugs, orthokeratology, defocused soft contact lens, defocused spectacles, etc; 5. Those who had undergone corneal refractive surgery before; 6. Those with epilepsy or mental disorders who can not communicate normally; 7. Other situations that are judged by the researcher as unsuitable to participate in the research.

Design outcomes

Primary

MeasureTime frame
Axial Length;

Secondary

MeasureTime frame
Refractive Status;

Countries

China

Contacts

Public ContactXu Xun

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital

drxuxun@sjtu.edu.cn+86 13386259538

Outcome results

None listed

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