Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

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

Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial

China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

796

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 12 to 17 years;
  • Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 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
CARE1.02
Device: CARE1.02
Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.
Active Comparator: Control group
Single-vision spectacle lens
Device: Single-vision spectacle lens
Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of spherical equivalent refraction (SER) at one year
Time Frame: 1 year
The difference of SER at one year from baseline. SER will be measured after cycloplegia
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safty of wearing the spectacle lens
Time Frame: 1 year
Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.
1 year
Changes of axial length (AL) at one year
Time Frame: 1 year
The difference of AL at one year from baseline.
1 year
Change of anterior chamber depth (ACD) at one year
Time Frame: 1 year
The difference of ACD at one year from baseline.
1 year
Change of lens thickness (LT) at one year
Time Frame: 1 year
The difference of LT at one year from baseline.
1 year
Change of corneal curvature (CR) at one year
Time Frame: 1 year
The difference of CR at one year from baseline.
1 year
Best corrected visual acuity at one year
Time Frame: 1 year
Best corrected visual acuity
1 year
Binocular visual function at one year
Time Frame: 1 year
Binocular visual function
1 year
Choroidal thickness at one year
Time Frame: 1 year
The difference of Choroidal thickness at one year from baseline.
1 year
Visual scale score at 1 year
Time Frame: 1 year
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)
1 year
Time length of wearing spectcales at one year
Time Frame: 1 year
Time length of wearing spectcales collected every half year
1 year

Collaborators and Investigators

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

Sponsor

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)

April 25, 2023

Primary Completion (Actual)

June 12, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 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

  • 2023KYPJ005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The researchs will share the IPD as request in future.

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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