Efficacy and Safety of Dual-Effect Myopia Control Lenses for Slowing Myopia Progression: A Single-Center, Randomized, Controlled, Noninferiority Trial

November 8, 2026 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University

This study aims to evaluate the efficacy and safety of dual-effect myopia control spectacle lenses in slowing myopia progression compared with Nikon MyoEase 2.0 lenses in children aged 8-13 years.

This is a single-center, randomized, open-label, parallel-group, noninferiority clinical trial. A total of 194 children with myopia will be randomly assigned in a 1:1 ratio to wear either dual-effect myopia control spectacle lenses or Nikon MyoEase 2.0 lenses for 12 months.

The primary outcome is the change in cycloplegic objective spherical equivalent refraction from baseline to 12 months. Secondary outcomes include changes in refractive error, ocular biometric parameters, visual acuity, binocular visual function, and visual questionnaire scores. Safety will also be assessed throughout the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 8-13 years, regardless of sex, with written consent from both the participant and their legal guardian.
  2. Cycloplegic objective spherical equivalent refraction between -4.75 D and -0.75 D (inclusive) in both eyes, astigmatism ≥-1.50 D, and an absolute interocular difference in spherical equivalent refraction ≤1.00 D.
  3. Best-corrected visual acuity ≥1.0 in both eyes.
  4. Intraocular pressure within the normal range (10-21 mmHg) in both eyes.
  5. Voluntary participation in the study with signed informed consent.

Exclusion Criteria:

  1. History of ocular trauma or intraocular surgery.
  2. Clinically abnormal slit-lamp examination findings.
  3. Fundus examination grade ≥2.
  4. Other ocular diseases, including uveitis or other ocular inflammation, glaucoma, cataract, fundus disease, ocular tumors, ocular trauma, manifest strabismus, or any ocular condition affecting visual function.
  5. Systemic diseases associated with immunodeficiency or conditions considered by the investigator unsuitable for spectacle wear, such as diabetes, Down syndrome, rheumatoid arthritis, or psychiatric disorders.
  6. Participation in a drug clinical trial within the previous 3 months or a medical device clinical trial within the previous month.
  7. Meeting the inclusion criteria in only one eye.
  8. Inability to attend regular ophthalmic examinations.
  9. Participation in any myopia control clinical trial within the previous 3 months, or previous or current use of rigid contact lenses (including associated care products), multifocal contact lenses, progressive addition lenses or other specially designed myopia control spectacle lenses, or atropine.
  10. Deemed ineligible by the investigator.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dual-Effect Myopia Control Lenses

Participants in this group will wear dual-effect myopia control spectacle lenses for 12 months, with a recommended daily wearing time of at least 12 hours.
Device: Dual-Effect Myopia Control Spectacle Lenses

Dual-effect myopia control spectacle lenses manufactured by Jiangsu Kangmeida Optical Co., Ltd. Participants will be advised to wear the spectacles for at least 12 hours per day for 12 months.
Active Comparator: Nikon Kongyoudian 2.0 Lenses

Participants in this group will wear Nikon Kongyoudian 2.0 spectacle lenses for 12 months, following the same wearing instructions as the experimental group.
Device: Nikon Kongyoudian 2.0 Spectacle Lenses

Nikon Kongyoudian 2.0 spectacle lenses manufactured by Nikon Optical Co., Ltd. The lenses will be used in the same manner as the investigational lenses for 12 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cycloplegic Spherical Equivalent Refraction at 12 Months
Time Frame: Baseline and 12 months (±30 days)

Change in spherical equivalent refraction (SER) from baseline to 12 months, measured by objective autorefraction under cycloplegia. SER is calculated as sphere power plus half the cylinder power, expressed in diopters (D).
Baseline and 12 months (±30 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Axial Length
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in axial length from baseline, measured before cycloplegia using optical biometry.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Cycloplegic Spherical Equivalent Refraction at 6 Months
Time Frame: Baseline and 6 months (±30 days)

Change in spherical equivalent refraction (SER) from baseline to 6 months, measured by objective autorefraction under cycloplegia, expressed in diopters (D).
Baseline and 6 months (±30 days)
Visual Acuity With Study Spectacles
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Visual acuity measured while wearing the assigned study spectacles.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Corneal Curvature
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in corneal curvature from baseline, measured before cycloplegia using optical biometry.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Anterior Chamber Depth
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in anterior chamber depth from baseline, measured before cycloplegia using optical biometry.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Lens Thickness
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in crystalline lens thickness from baseline, measured before cycloplegia using optical biometry.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Change in Subjective Refraction
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in subjective refraction from baseline, assessed before cycloplegia.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Best-Corrected Visual Acuity
Time Frame: 6 months (±30 days) and 12 months (±30 days)

Best-corrected visual acuity assessed using an ETDRS logMAR E chart.
6 months (±30 days) and 12 months (±30 days)
Change in Binocular Visual Function
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Change in binocular visual function from baseline, assessed at follow-up visits.
Baseline, 6 months (±30 days), and 12 months (±30 days)
Visual Questionnaire Score
Time Frame: 6 months (±30 days) and 12 months (±30 days)

Visual assessment using the Chinese version of the PRER2 questionnaire.
6 months (±30 days) and 12 months (±30 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events and Serious Adverse Events
Time Frame: Throughout the 12-month study period

Occurrence of symptoms, signs, complications, adverse events, and serious adverse events related to the study products or procedures.
Throughout the 12-month study period
Intraocular Pressure
Time Frame: 6 months (±30 days), and 12 months (±30 days)

Intraocular pressure measured using non-contact tonometry, expressed in mmHg.
6 months (±30 days), and 12 months (±30 days)
Fundus Examination Grade
Time Frame: 6 months (±30 days), and 12 months (±30 days)

Fundus findings assessed and graded according to the study protocol.
6 months (±30 days), and 12 months (±30 days)
Spectacle Frame Position Assessment
Time Frame: Baseline, 6 months (±30 days), and 12 months (±30 days)

Assessment of spectacle frame positioning and lens condition according to the study protocol.
Baseline, 6 months (±30 days), and 12 months (±30 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu KMD OPTICAL CO.,LTD

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026KYPJ157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with external researchers.

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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