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

NCT07284147 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Phase

Not applicable

Started

2025-09-01

Last updated

2025-12-16

Condition(s) studied

Myopia Progressing

Investigational drug(s) / intervention(s)

Defocus Lenses

Defocus Lenses: Defocus Lenses on Myopia Control

Study summary

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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

14 Years

Healthy volunteers

Accepted

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: \-

Primary outcome measure(s)

Subjective refraction equivalent spherical — 12 months
Subjective refraction equivalent spherical

Trial sites (1)

Facility	City	Region	Status
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University	Shanghai	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284147 on ClinicalTrials.gov ↗ ← All trials in China