3D Designed Defocus Lenses on Myopia Control in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Defocus Lenses.
- Who it may be relevant to
- Registry conditions: Myopia Progressing. Basic parameters: 6 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on the Control Effect of 3D Designed Defocus Lenses on Myopia in Children and Adolescents
Overview
This study aims to evaluate the effectiveness of lenses with 3D Designed Defocus in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.
Interventions
- Device Defocus Lenses
Defocus Lenses on Myopia Control
Primary outcome measures
- Subjective refraction equivalent spherical [Time frame: 12 months]
Secondary outcome measures (2)
- Axial length [Time frame: 12 months]
- Choroidal thickness [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
Age: 6-14 years old; After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.40D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is ≤ 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0; Within 3 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medic — Shanghai
Identifiers
NCT: NCT07284147 · QX-2025-A-012