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MyopiaNCT05740930

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

A study testing Partition defocus myopia management spectacle lens and Spectacle lenses with aspherical lenslets 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

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. Read more about this study

Who is it for?
Ages 8 to 13 years
Conditions the study is for
Myopia
What is being tested?
Partition defocus myopia management spectacle lens and Spectacle lenses with aspherical lenslets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteChina
Study dates
20 Mar 2023to 27 May 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 8 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

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: 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.

Read the 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.

Conditions
Myopia
Being tested
Partition defocus myopia management spectacle lens, Spectacle lenses with aspherical lenslets
Keywords
Partition multi-point defocused, 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.

  • Partition defocus myopia management spectacle lensOther

    Participants in the intervention group will receive the partition defocus myopia management spectacles lens and receive follow-up checks.

  • Spectacle lenses with aspherical lensletsOther

    Participants in the control group will receive the spectacle lenses with aspherical lenslets and receive follow-up checks.

Study groups in NCT05740930
Study groupRoleWhat they receive
Intervention groupExperimentalThe participants wear the partition defocus myopia management spectacle lens.
Receives: Other: Partition defocus myopia management spectacle lens
Control groupActive comparatorspectacle lenses with aspherical lenslets
Receives: Other: Spectacle lenses with aspherical lenslets

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 two years

    The difference of SER (Diopter) at two years from baseline. SER will be measured every year after cycloplegia.

    Measured: 2 years

Secondary outcomes (11)
  1. Changes of axial length (AL) at two years

    The difference of AL (mm) at two years from baseline. AL will be measured every half year by IOLMaster700.

    Measured: 2 years

  2. Change of anterior chamber depth (ACD) at two years

    The difference of ACD(mm) at two years from baseline. ACD will be measured every half year by IOLMaster700.

    Measured: 2 years

  3. Change of lens thickness (LT) at two years

    The difference of LT (mm) at two years from baseline. LT will be measured every half year by IOLMaster700.

    Measured: 2 years

  4. Change of corneal power (CP) at two years

    The difference of CP (Diopter) at two years from baseline. CP will be measured every half year by IOLMaster700.

    Measured: 2 years

  5. Best corrected visual acuity at two years

    Best corrected visual acuity measured every year by EDTRS visual acuity chart after cycloplegia.

    Measured: 2 years

  6. Binocular visual function at two years

    Binocular visual function which will be measured every year is a qualitative outcome assessed by a series of tests.

    Measured: 2 years

  7. Choroidal thickness at two years

    The difference of Choroidal thickness (μm) at two years from baseline. Choroidal thickness will be measured every year by OCTA.

    Measured: 2 years

  8. Visual scale score at six 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).

    Measured: 6 months

  9. Visual scale score at two 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).

    Measured: 2 years

  10. Time length of wearing spectcales at two 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.

    Measured: 2 years

  11. 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 based on symptoms and signs, intraocular pressure,slit lamp and ocular fundus checks.

    Measured: 2 years

Timeline

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

  1. First posted23 Feb 2023
  2. Study start20 Mar 2023
  3. Primary completion27 May 2025
  4. Study completion27 May 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
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740930
Sponsor's protocol ID
2023KYPJ004
Status last verified
Mar 2026
First submitted
8 Feb 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.

    PubMed 23109740
  • Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30.

    PubMed 33388160
  • Rose K, Harper R, Tromans C, Waterman C, Goldberg D, Haggerty C, Tullo A. Quality of life in myopia. Br J Ophthalmol. 2000 Sep;84(9):1031-4. doi: 10.1136/bjo.84.9.1031.

    PubMed 10966960
  • 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
  • Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.

    PubMed 33607016
  • He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.

    PubMed 19104465
  • 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
  • Huang J, Hung LF, Smith EL 3rd. Recovery of peripheral refractive errors and ocular shape in rhesus monkeys (Macaca mulatta) with experimentally induced myopia. Vision Res. 2012 Nov 15;73:30-9. doi: 10.1016/j.visres.2012.09.002. Epub 2012 Sep 28.

    PubMed 23026012
  • Smith EL 3rd, Hung LF, Huang J, Blasdel TL, Humbird TL, Bockhorst KH. Effects of optical defocus on refractive development in monkeys: evidence for local, regionally selective mechanisms. Invest Ophthalmol Vis Sci. 2010 Aug;51(8):3864-73. doi: 10.1167/iovs.09-4969. Epub 2010 Mar 10.

    PubMed 20220051
  • Smith EL 3rd, Hung LF, Huang J, Arumugam B. Effects of local myopic defocus on refractive development in monkeys. Optom Vis Sci. 2013 Nov;90(11):1176-86. doi: 10.1097/OPX.0000000000000038.

    PubMed 24061154

Questions about this trial

What is this clinical trial studying?

A study testing Partition defocus myopia management spectacle lens and Spectacle lenses with aspherical lenslets 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 two years (time frame: 2 years). 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 NCT05740930, which also lists 13 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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