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Enrolling by Invitation

NCT Number: NCT07284147

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

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.

Enrolling by Invitation

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Key information

Conditions

Myopia Progressing Eye Diseases Myopia Refractive Errors

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Defocus Lenses

Device

Defocus Lenses on Myopia Control

Primary outcomes

  1. Subjective refraction equivalent spherical

    Time frame: 12 months

    Subjective refraction equivalent spherical

Secondary outcomes

  1. Axial length

    Time frame: 12 months

    Axial length

  2. Choroidal thickness

    Time frame: 12 months

    Choroidal thickness

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Clinical Study on the Control Effect of 3D Designed Defocus Lenses on Myopia in Children and Adolescents

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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