Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07514039

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Myopia, Child Myopia Progression 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 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.

Treatment and study plan

Myopia management lens

Device

Microstructure myopia management lens

Primary outcomes

  1. Changes in spherical equivalent (SE)

    Time frame: 12 months

    Changes in spherical equivalent (SE) of mydriatic refraction compared to baseline (D)

Secondary outcomes

  1. Changes in axial length (AL)

    Time frame: 12 months

    Changes in axial length (AL) compared to baseline (mm)

  2. Changes in choroidal thickness (ChT)

    Time frame: 12 months

    Changes in choroidal thickness (ChT) compared to baseline (μm)

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.