Photolithography Microstructure Myopia Management Lenses in Preventing and Controlling Myopia in Children and Adolescents

A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing Myopia in Children and Adolescents

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07514039

Enrollment

252

Registered

2026-04-07

Start date

2026-02-01

Completion date

2027-12-31

Last updated

2026-04-07

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

Conditions

Myopia, Child Myopia Progression

Keywords

lithographic microstructured myopia management lenses, myopia progression, Chinese children

Brief summary

Evaluate the effectiveness of different lithographic microstructured myopia management lenses in controlling the progression of myopia in children and adolescents, as well as the safety and comfort of wearing them. Explore effective defocus microlens designs for myopia control and the feasibility of applying lithographic microstructured myopia management lenses in myopia prevention and control.

Interventions

DEVICEMyopia management lens

Microstructure myopia management lens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: 6 to 14 years old. * After administering 1% Cyclopentolate Hydrochloride Eye Drops (Saifeijie) to induce ciliary muscle paralysis, both eyes showed refractive errors between -0.50D and -4.00D, with binocular lens differences ≤ 1.50D and anisometropia ≤ 1.50D. Best corrected visual acuity was 5.0 or better. * Have not used over-focus glasses, corneal reshaping lenses, defocus flexible glasses, progressive lenses, atropine eye drops, red light therapy, acupuncture, moxibustion, or other myopia prevention methods within the past three months. * The subject is willing to receive treatment, and their legal guardian has signed an informed consent form.

Exclusion criteria

* Diagnosed with persistent strabismus. * Diagnosed with pathological myopia. * Other congenital eye diseases. * Other reasons the research doctor deems unsuitable for inclusion in the project.

Design outcomes

Primary

Measure	Time frame	Description
Changes in spherical equivalent (SE)	12 months	Changes in spherical equivalent (SE) of mydriatic refraction compared to baseline (D)

Secondary

Measure	Time frame	Description
Changes in axial length (AL)	12 months	Changes in axial length (AL) compared to baseline (mm)
Changes in choroidal thickness (ChT)	12 months	Changes in choroidal thickness (ChT) compared to baseline (μm)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026