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A prospective randomized controlled clinical study on the use of red diffuser myopia control frame lenses in children

A prospective randomized controlled clinical study on the use of red diffuser myopia control frame lenses in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105613
Enrollment
Unknown
Registered
2025-07-08
Start date
2025-07-08
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Myopia

Interventions

Negative control group:Single-vision lenses
Positive control group:Design of high aspheric microlens defocus lenses
Experimental group:Red diffuser defocus lens

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age between 6 and 14 years old (inclusive of 6 and 14 years old). 2. Under cycloplegia, the equivalent spherical refractive power range of subjective refraction for both eyes is -0.75D to -6.00D (including -0.75D and -6.00D), and the astigmatism value of subjective refraction for both eyes is less than or equal to 2.00D. 3. Anisometropia of both eyes is less than 1.50D. 4. Best corrected visual acuity (BVCA) is greater than or equal to 1.0. 5. Parents/guardians and children sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Any ocular or systemic diseases that may affect visual function or refractive development. For instance, strabismus, cataract, glaucoma, etc. 2. Previous history of ocular trauma and surgery. 3. Previous experience with other treatments for myopia control. For example, orthokeratology, multifocal soft contact lenses, vision training, drug therapy, etc.

Design outcomes

Primary

MeasureTime frame
Axial length;Cycloplegic objective refraction spherical equivalent ;

Secondary

MeasureTime frame
Cloud Clip eye behavior parameters;Choroidal thickness;Wide-field retinal refractive power measurement;

Countries

China

Contacts

Public ContactXiaoning Li

Changsha Aier Eye Hospital

lixiaoning@aierchina.com+86 189 7589 7052

Outcome results

None listed

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