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MyopiaNCT05818033

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

A study testing CARE1.02 and Single-vision spectacle lens in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Myopia
What is being tested?
CARE1.02 and Single-vision spectacle lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
796 participants
Where
1 siteChina
Study dates
25 Apr 2023to 12 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Conditions
Myopia
Being tested
CARE1.02, Single-vision spectacle lens
Keywords
Myopia control
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CARE1.02Device

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

  • Single-vision spectacle lensDevice

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

Study groups in NCT05818033
Study groupRoleWhat they receive
Intervention groupExperimentalCARE1.02
Receives: Device: CARE1.02
Control groupActive comparatorSingle-vision spectacle lens
Receives: Device: Single-vision spectacle lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of spherical equivalent refraction (SER) at one year

    The difference of SER at one year from baseline. SER will be measured after cycloplegia

    Measured: 1 year

Secondary outcomes (10)

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

    The difference of AL at one year from baseline.

    Measured: 1 year

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

    The difference of ACD at one year from baseline.

    Measured: 1 year

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

    The difference of LT at one year from baseline.

    Measured: 1 year

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

    The difference of CR at one year from baseline.

    Measured: 1 year

  5. Best corrected visual acuity at one year

    Best corrected visual acuity

    Measured: 1 year

  6. Binocular visual function at one year

    Binocular visual function

    Measured: 1 year

  7. Choroidal thickness at one year

    The difference of Choroidal thickness at one year from baseline.

    Measured: 1 year

  8. Visual scale score at 1 year

    Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)

    Measured: 1 year

  9. Time length of wearing spectcales at one year

    Time length of wearing spectcales collected every half year

    Measured: 1 year

  10. Safty of wearing the spectacle lens

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start25 Apr 2023
  3. Primary completion12 Jun 2025
  4. Study completion12 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
796 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818033
Sponsor's protocol ID
2023KYPJ005
Status last verified
Mar 2026
First submitted
5 Apr 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The researchs will share the IPD as request in future.

Publications

  • Irving EL, Yakobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic Physiol Opt. 2017 Sep;37(5):576-584. doi: 10.1111/opo.12400. Epub 2017 Jul 26.

    PubMed 28746982

  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

    PubMed 26875007

  • Naidoo KS, Fricke TR, Frick KD, Jong M, Naduvilath TJ, Resnikoff S, Sankaridurg P. Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling. Ophthalmology. 2019 Mar;126(3):338-346. doi: 10.1016/j.ophtha.2018.10.029. Epub 2018 Oct 17.

    PubMed 30342076

  • Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958.

    PubMed 30817829

  • Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

    PubMed 33811039

  • Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.

    PubMed 10343811

  • Wallman J, Gottlieb MD, Rajaram V, Fugate-Wentzek LA. Local retinal regions control local eye growth and myopia. Science. 1987 Jul 3;237(4810):73-7. doi: 10.1126/science.3603011.

    PubMed 3603011

  • Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.

    PubMed 18055781

  • Arumugam B, Hung LF, To CH, Sankaridurg P, Smith EL III. The Effects of the Relative Strength of Simultaneous Competing Defocus Signals on Emmetropization in Infant Rhesus Monkeys. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):3949-60. doi: 10.1167/iovs.16-19704.

    PubMed 27479812

  • Tse DY, To CH. Graded competing regional myopic and hyperopic defocus produce summated emmetropization set points in chick. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8056-62. doi: 10.1167/iovs.10-5207.

    PubMed 21911586

  • Woods J, Guthrie SE, Keir N, Dillehay S, Tyson M, Griffin R, Choh V, Fonn D, Jones L, Irving E. Inhibition of defocus-induced myopia in chickens. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2662-8. doi: 10.1167/iovs.12-10742.

    PubMed 23471891

Questions about this trial

What is this clinical trial studying?

A study testing CARE1.02 and Single-vision spectacle lens in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of spherical equivalent refraction (SER) at one year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818033, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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