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Completed

NCT Number: NCT05818033

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

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CARE1.02

Device

Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.

Single-vision spectacle lens

Device

Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes of axial length (AL) at one year

    Time frame: 1 year

    The difference of AL at one year from baseline.

  2. Change of anterior chamber depth (ACD) at one year

    Time frame: 1 year

    The difference of ACD at one year from baseline.

  3. Change of lens thickness (LT) at one year

    Time frame: 1 year

    The difference of LT at one year from baseline.

  4. Change of corneal curvature (CR) at one year

    Time frame: 1 year

    The difference of CR at one year from baseline.

  5. Best corrected visual acuity at one year

    Time frame: 1 year

    Best corrected visual acuity

  6. Binocular visual function at one year

    Time frame: 1 year

    Binocular visual function

  7. Choroidal thickness at one year

    Time frame: 1 year

    The difference of Choroidal thickness at one year from baseline.

  8. 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)

  9. Time length of wearing spectcales at one year

    Time frame: 1 year

    Time length of wearing spectcales collected every half year

  10. 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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