Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

April 7, 2025 updated by: Shanghai Eye Disease Prevention and Treatment Center
This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

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
      • Shanghai, Shanghai, China, 200050
        • 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

No

Description

Inclusion Criteria:

  1. Age: 6-14 years old;
  2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
  3. Within 30 days, 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;
  4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria:

  1. Diagnosed constant strabismus;
  2. Diagnosed pathological myopia;
  3. Other congenital eye diseases;
  4. Researchers believe that the patients have other reasons that are not suitable 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: H.M.E.C，High Precision Micro Encircle
Device: Defocus microlenses
Different microlenses array (H.M.E.C，High Precision Micro Encircle and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.
Active Comparator: H. A. L. T, highly aspheric lenslet technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective refraction equivalent spherical
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Axial length
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other biological parameters
Time Frame: 2 years
amplitude of accommodation, anterior chamber depth, corneal curvature, white to white distance, central corneal thickness, lens thickness ,pupil size, multispectral refraction topography, choroidal thickness, objective visual quality, wavefront aberration, contrast sensitivity, and strabismus (mahalanobis bar method).
2 years
Best corrected visual acuity
Time Frame: 2 years
2 years
questionnaires of daily eye habits and wearing time of subjects collected
Time Frame: 2 years
2 years

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)

August 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QX-2024-A-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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