Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control

March 11, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

Effectiveness and Safety of Partition Multi-point Defocused Myopia Management Spectacle Lens in Myopia Control Compared With Spectacle Lenses With Aspherical Lenslets: a Randomised Non-inferiority Trial

Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myopia is considered to be the most common type of refractive error, and it has increased rapidly worldwide. The vision damage caused by uncorrected myopia seriously affects the quality of life, may lead to poor academic performance of children, and cause considerable economic burden. About 90% of vision damage caused by myopia can be prevented by cost-effective interventions or treatment.

In recent years, the incidence of myopia has shown a trend of low age. Therefore, clinical intervention should be carried out in the childhood stage, which is the key period of eye development, to control the progress of myopia. A recent 2-year randomized controlled study in China found that the new aspheric microlens myopia control spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. Different studies have found or proved the technical principle of the new aspheric defocusing microlens.

Animal experiments found that the direction, intensity and regional distribution of optical defocus signals have a substantial impact on the growth of eyes; The diopter of peripheral relative hyperopia can affect the central myopia; The changes of myopia and optical defocus in the nasal and temporal regions can change the shape and peripheral refraction of the eyes; Local changes in the effective focus of the eye will lead to regional changes in eye growth and refractive error. Based on the findings of animal experiments, the new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.

A prospective, single-center, open-label, non-inferiority randomized controlled trial is developed to evaluate the effectiveness and safety of partition multi-point defocused myopia management spectacle lens among children in China in myopia control.

Study Type

Interventional

Enrollment (Actual)

194

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen 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

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 8 to 13 years;
  • Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.75 to -4.75 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.00 D;
  • Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen).
  • The intraocular pressure of 10 to 21mmHg.
  • Volunteer to participate in this clinical trial with signature of the informed consent form.

Exclusion Criteria:

  • History of eye injury or intraocular surgery;
  • Clinically abnormal slit-lamp findings
  • Abnormal fundus examination
  • Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
  • Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
  • Participation of the drug clinical trial within three month and the device clinical trial within one month;
  • Only one eye meets the inclusion criteria;
  • Unable to have regular follow-up
  • Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The participants wear the partition defocus myopia management spectacle lens.
Other: Partition defocus myopia management spectacle lens
Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks.
Active Comparator: Control group
spectacle lenses with aspherical lenslets
Other: Spectacle lenses with aspherical lenslets
Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of spherical equivalent refraction (SER) at two years
Time Frame: 2 years
The difference of SER (Diopter) at two years from baseline. SER will be measured every year after cycloplegia.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of axial length (AL) at two years
Time Frame: 2 years
The difference of AL (mm) at two years from baseline. AL will be measured every half year by IOLMaster700.
2 years
Change of anterior chamber depth (ACD) at two years
Time Frame: 2 years
The difference of ACD（mm） at two years from baseline. ACD will be measured every half year by IOLMaster700.
2 years
Change of lens thickness (LT) at two years
Time Frame: 2 years
The difference of LT (mm) at two years from baseline. LT will be measured every half year by IOLMaster700.
2 years
Change of corneal power (CP) at two years
Time Frame: 2 years
The difference of CP (Diopter) at two years from baseline. CP will be measured every half year by IOLMaster700.
2 years
Best corrected visual acuity at two years
Time Frame: 2 years
Best corrected visual acuity measured every year by EDTRS visual acuity chart after cycloplegia.
2 years
Binocular visual function at two years
Time Frame: 2 years
Binocular visual function which will be measured every year is a qualitative outcome assessed by a series of tests.
2 years
Choroidal thickness at two years
Time Frame: 2 years
The difference of Choroidal thickness (μm) at two years from baseline. Choroidal thickness will be measured every year by OCTA.
2 years
Visual scale score at six months
Time Frame: 6 months
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life).
6 months
Visual scale score at two years
Time Frame: 2 years
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) and scaled from 0 (poor quality of life) to 100 (good quality of life).
2 years
Time length of wearing spectcales at two years
Time Frame: 2 years
Time length of wearing spectcales collected every half year. Participants report the approximate time of wearing glasses per day and the days of wearing glasses per week.
2 years
Safty of wearing the spectacle lens
Time Frame: 2 years
Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations based on symptoms and signs, intraocular pressure，slit lamp and ocular fundus checks.
2 years

Collaborators and Investigators

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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yangfa Zeng, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 20, 2023

Primary Completion (Actual)

May 27, 2025

Study Completion (Actual)

May 27, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023KYPJ004

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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