3D Designed Defocus Lenses on Myopia Control in Children and Adolescents

Shanghai Eye Disease Prevention and Treatment Center

Status: Invitation-only

Conditions: Myopia Progressing

Treatments: Device: Defocus Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07284147

QX-2025-A-012

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

-

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

Experimental: 3D lens

Experimental group

Description:

3D Designed Defocus Lenses

Treatment:

Device: Defocus Lenses

Control: H. A. L. T, highly aspheric lenslet technology

Active Comparator group

Description:

H. A. L. T, highly aspheric lenslet technology

Treatment:

Device: Defocus Lenses