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Clinical Study on the Use of Micro-aperture Astigmatism Lenses to Control the Progression of Myopia in Children and Adolescents

Clinical Study on the Use of Micro-aperture Astigmatism Lenses to Control the Progression of Myopia in Children and Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094258
Enrollment
Unknown
Registered
2024-12-19
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Axial myopia, Curvature myopia, Mixed myopia of Children and Adolescents

Interventions

Experimental group:Wear Micro-aperture astigmatism lenses
Control group:Wear ordinary monocal glasses

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Older than 5 years old and less than or equal to 18 years old, gender is not limited; 2. Diagnosed myopia: after cycloplegia, the equivalent spherical magnicity (SE) of at least one eye is between -0.5D ~ -6.00D (including boundary value); 3. Astigmatism=1.0 (decimal recording method); 6. The subject or his guardian is willing to treat and is willing to sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Confirmed pathological myopia; 2. Amblyopia or oblique person; 3. Those with intraocular slant; 4. Other congenital eye diseases; 5. SE<=-6.00D for either or both parents; 6. Patients with abnormal axial length; 7. Those with cataract, glaucoma and other vitreoretinal diseases; 8. Those with a history of atropine drug use; 9. Combined with acute inflammation of the eye; 10. Participated in the same type of clinical trial with controlled myopia progression as the defocus lens in the past three months; 11. Other reasons that the study doctor deems unsuitable for inclusion in the program;

Design outcomes

Primary

MeasureTime frame
Microaperture defocusing lens delays myopia progression rate;

Secondary

MeasureTime frame
Diopter growth value;Axial growth value;Anisometropia in both eyes;Increases in anterior chamber depth, crystal thickness, and vitreous cavity depth;Evaluation of subjects;Incidence of Serious Adverse Event and Adverse Event;The change of diaphanous degree between the two groups;

Countries

China

Contacts

Public ContactLiu Yang

Fifth Affiliated Hospital, Sun Yat-Sen University

yangliu_manu@163.com+86 756 2528895

Outcome results

None listed

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