Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses
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 spectacle lenses.
- Who it may be relevant to
- Registry conditions: Myopia, Progressive. 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
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
Overview
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.
Interventions
- Device defocus spectacle lenses
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.
Primary outcome measures
- Axial length [Time frame: 2 years]
Secondary outcome measures (1)
- Subjective refraction equivalent spherical [Time frame: 2 years]
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 0.00D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
- Within 30 days, 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
- Diagnosed constant strabismus;
- Diagnosed pathological myopia;
- Other congenital eye diseases;
- Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of M — Shanghai
Identifiers
NCT: NCT06221592 · QX-2023-A-03