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

March 31, 2026 updated by: Shanghai Eye Disease Prevention and Treatment Center

A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photolithography microstructure myopia management lens (A)
Device: Myopia management lens
Microstructure myopia management lens
Experimental: Photolithography microstructure myopia management lens (B)
Device: Myopia management lens
Microstructure myopia management lens
Experimental: Photolithography microstructure myopia management lens (C)
Device: Myopia management lens
Microstructure myopia management lens
Active Comparator: Myopia Management Lenses (highly aspherical lenslets)
Device: Myopia management lens
Microstructure myopia management lens

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QX-2025-A-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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