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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07284147
Enrollment
144
Registered
2025-12-16
Start date
2025-09-01
Completion date
2027-08-31
Last updated
2025-12-16

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

Conditions

Myopia Progressing

Keywords

myopia

Brief 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.

Interventions

DEVICEDefocus Lenses

Defocus Lenses on Myopia Control

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Subjective refraction equivalent spherical12 monthsSubjective refraction equivalent spherical

Secondary

MeasureTime frameDescription
Axial length12 monthsAxial length
Choroidal thickness12 monthsChoroidal thickness

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026