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Safety, adaptability and effectiveness and of defocusing lens based on Bionic-Compound Multifocal Defocus (B.C.M.D.) technology in delaying the progression of myopia

Safety, adaptability and effectiveness and of defocusing lens based on Bionic-Compound Multifocal Defocus (B.C.M.D.) technology in delaying the progression of myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068393
Enrollment
Unknown
Registered
2023-02-17
Start date
2023-02-17
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

ametropia

Interventions

group A:Wear bionic compound eye defocusing (B.C.M.D.) glasses
group B:Wear STELLEST glasses
group C:Wear ordinary frame glasses

Sponsors

The 2nd Affiliated Hospital of Medical College, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: (1) Age 8-15, male or female (2) The diopter of objective refraction spherical lens under mydriasis of both eyes is -0.75D~-5.00D (including -0.75D and -5.00D), and the astigmatism is = -1.50D, and the diopter deviation of both eyes behind the equivalent spherical lens is = 1.00D; (3) The best corrected visual acuity of binocular subjective optometry was = 1.0; (4) There were no other abnormalities or diseases in both eyes except for ametropia; (5) The patient is willing to complete the visit and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Premature infants; (2) Strabismus or binocular vision abnormalities; (3) Patients who are using or need to use drugs that may cause dry eyes or affect vision (such as penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, ethambutol, etc.) during follow-up study; (4) People with systemic diseases; (5) Products that have used or are using to delay the progress of myopia within one year, such as specially designed myopia control lenses (including frame glasses, OK lenses, RGP, multifocal contact lenses, progressive multifocal lenses, etc.), atropine drugs; (6) Other circumstances that the researcher judges are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Computer optometry equivalent spherical under ciliary muscle paralysis;Diopter;

Secondary

MeasureTime frame
Axial length;Blood flow density of retina and choroid;

Countries

China

Contacts

Public ContactNi Hailong

The 2nd Affiliated Hospital of Medical College, Zhejiang University

2101092@zju.edu.cn022-86428703

Outcome results

None listed

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