Skip to content

The safety, effectiveness and adaptability of defocus frame lenses are used for vision correction and myopia prevention and control in children and adolescents

The safety, effectiveness and adaptability of defocus frame lenses are used for vision correction and myopia prevention and control in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099951
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-20
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Myopia

Interventions

Experimental group 1:Wear Xinnuotong ?defocus lenses
Experimental group 2:Wear Xinleyue ? lenses
Control Group:Wear single vision lenses

Sponsors

Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1.Age 8~13 years old (including 8 years old and 13 years old), male or female; 2.After cycloplegia in both eyes, the equivalent spherical power of subjective refraction is -0.75D~-5.00D (including -0.75D and -5.00D), the astigmatism = 1.0 (decimal visual acuity); 4.Except for refractive error, there are no other abnormalities or diseases in both eyes; 5.Patients and guardians are willing to complete the visit and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Overt strabismus or significant abnormalities in binocular visual function; 2.Patients who are using or need to use drugs that may cause dry eyes or affect vision (such as penicillin, streptomycin, chlorampheniol, sulfonamides, isoniazid, etc.) during the follow-up study; 3.Patients with systemic diseases; 4.Have used or are using products that delay the progression of myopia within 3 months, such as specially designed myopia control lenses (including eyeglasses, OK lenses, RGP, multifocal contact lenses, progressive multifocal lenses, etc.), atropine drugs, repetitive low-intensity red light, etc. 5.Other conditions judged by the investigator to be unsuitable for inclusion;

Design outcomes

Primary

MeasureTime frame
Axial Length, AL;Sphere Equivalent, SE;

Secondary

MeasureTime frame
Best corrected distance visual acuity;VA?Objective refraction spherical equivalent;Visual function;

Countries

China

Contacts

Public ContactDu Bei

Tianjin Medical University Eye Hospital

dubei1982@126.com+86 13920914782

Outcome results

None listed

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