Myopia, ProgressiveNCT07264361
Evaluation of the Safety and Efficacy of the D.D.C Dual-control Technology Spectacle Lenses in Delaying the Progression of Myopia: a Randomized Controlled Trial
A study testing Aspheric single-vision lenses in people with Myopia, Progressive, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The burden of myopia among Chinese children and adolescents is severe and trending toward younger ages, making control of myopia progression a public health priority. Current mainstream strategies include optical interventions, pharmacologic therapy, and environmental measures. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Aspheric single-vision lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2026to 20 Dec 2027
- Phase
- Interventional
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 and 14 years;
- Cycloplegic spherical equivalent refraction between -1.50 D and -5.00 D with astigmatism ≥ -1.50 D in both eyes;
- Absolute interocular difference in spherical equivalent refraction ≤ 1.50 D;
- Binocular best-corrected visual acuity ≥ 1.0;
- Intraocular pressure between 10 and 21 mmHg in both eyes;
- Volunteer to participate in this clinical trial with signature of the informed consent form.
Who cannot join
- History of eye injury or intraocular surgery or ocular trauma;
- Clinically abnormal slit-lamp findings;
- Abnormal fundus examination;
- Presence of ocular diseases such as cataract, glaucoma, fundus pathology, ocular trauma, manifest strabismus, or any other condition affecting 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 in a drug clinical trial within 3 months or a device clinical trial within 1 month prior to enrollment;
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- Participation in any myopia control clinical trial within the past 3 months and a history of myopia control interventions (e.g., orthokeratology, atropine);
- Only one eye meeting the inclusion criteria;
- Inability to attend regular ophthalmic examinations.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
The burden of myopia among Chinese children and adolescents is severe and trending toward younger ages, making control of myopia progression a public health priority. Current mainstream strategies include optical interventions, pharmacologic therapy, and environmental measures. Among these strategies, spectacle designs based on optical defocus-such as defocus-incorporated multiple-segment (DIMS) lenses-have demonstrated efficacy; however, the effect of such designs may attenuate over time because of "defocus adaptation." To address this limitation, D.D.C dual-control spectacles employ a densely staggered microlens layout, a gradient-defocus architecture, and an added peripheral "fogging zone" to disrupt the spatial distribution of defocus cues and reduce contrast, thereby delaying adaptation and enhancing myopia-control efficacy.
The present study therefore proposes a 24-month prospective randomized controlled trial in Guangzhou, enrolling eligible myopic adolescents. The trial will first compare 12-month outcomes between D.D.C-A lenses and single-vision lenses, followed by a crossover and alternating-wear phase, to systematically evaluate the safety and efficacy of the D.D.C technology in slowing myopia progression.
- Conditions
- Myopia, Progressive
- Being tested
- D.D.C dual-control technology spcetacle lenses, Aspheric single-vision lenses
- Keywords
- Defocus diffusion composite technology, Myopia control
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D.D.C dual-control technology spcetacle lensesDevice
The children in the intervention group will wear D.D.C dual-control technology spcetacle lenses type A for one year, with follow-up visits at baseline, 1 month, 6 months, and 12 months. And then they will be randomized in a 1:1 ratio to either continue with type A lenses or switch to type B lenses, which differ only in the defocus zone. Follow-up visits will be conducted at 13, 18, and 24 months.
Aspheric single-vision lensesDevice
The children in control group will wear aspheric single-vision lenses for one year, with follow-up visits at baseline, 1 month, 6 months, and 12 months. And then they will be randomized in a 1:1 ratio to either D.D.C dual-control technology spcetacle lenses type A lenses or alternate quarterly (every 3 months) between D.D.C dual-control technology spcetacle lenses type A and type B lenses. Follow-up visits will be conducted at 13, 18, and 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | D.D.C dual-control technology spectacle lenses Receives: Device: D.D.C dual-control technology spcetacle lenses |
| Control | Experimental | Aspheric single-vision spectacle lenes Receives: Device: Aspheric single-vision lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up
Change in cycloplegic SER (Diopter) from baseline to 12 months.
Measured: Baseline to 1 year
Secondary outcomes (17)
Changes in axial length (AL) during the 1-year follow-up
Changes in AL (mm) from baseline to 1, 6, and 12 months. AL will be measured using the IOLMaster 700 before cycloplegia.
Measured: Baseline to 1 year
Changes in spherical equivalent refraction (SER) from baseline during the 1-year follow-up, excluding the 12-month time point.
Change in cycloplegic SER (Diopter) from baseline to 1 and 6 months.
Measured: Baseline to 1 year
Changes in corneal curvature during the 1-year follow-up
Changes in corneal curvature (mm) from baseline to 1, 6, and 12 months. Corneal curvature will be measured by IOL Master-700 before cycloplegia.
Measured: Baseline to 1 year
Changes in anterior chamber depth (ACD) during the 1-year follow-up
Changes in ACD (mm) from baseline to 1, 6, and 12 months. ACD will be measured by IOL Master-700 before cycloplegia.
Measured: Baseline to 1 year
Changes in lens thickness (LT) during the 1-year follow-up
Changes in LT (mm) from baseline to 1, 6, and 12 months. LT will be measured by IOL Master-700 before cycloplegia.
Measured: Baseline to 1 year
Changes in spherical equivalent refraction (SER) at all time points from the 12-month follow-up during the 12-24 month follow-up period
Changes in cyclopegic SER (Diopter) from 12 months to 13, 18, and 24 months.
Measured: 1 year to 2 years
Changes in axial length (AL) from the 12-month follow-up during the 12-24 month follow-up period
Changes in AL (mm) from 12 months to 13, 18, and 24 months. AL will be measured using the IOL Master 700 before cyclopegia.
Measured: 1 year to 2 years
Changes in corneal curvature from the 12-month follow-up during the 12-24 month follow-up period
Changes in corneal curvature (mm) from 12 months to 13, 18, and 24 months. Corneal curvature will be measured by IOL Master-700 before cyclopegia.
Measured: 1 year to 2 years
Changes in anterior chamber depth (ACD) from the 12-month follow-up during the 12-24 month follow-up period
Changes in ACD (mm) from 12 months to 13, 18, and 24 months. ACD will be measured by IOL Master-700 before cyclopegia.
Measured: 1 year to 2 years
Changes in lens thickness (LT) from the 12-month follow-up during the 12-24 month follow-up period
Changes in LT (mm) from 12 months to 13, 18, and 24 months. LT will be measured by IOL Master-700 before cyclopegia.
Measured: 1 year to 2 years
Change in choroidal thickness from baseline to the 1-month follow-up
Change in choroidal thickness (μm) from baseline to 1 months.
Measured: Baseline to 1 month
Change in choroidal thickness from the 12-month to the 13-month follow-up
Change in choroidal thickness (μm) from the 12 months to the 13 months.
Measured: 1 year to 13 months
The proportion of participants who experienced clinically significant myopia progression
The proportion of participants who experienced clinically significant myopia progression (>0.5D/year) during the two-year follow-up
Measured: Baseline to 2 years
Spectacle wear compliance
Spectacle wearing time, assessed at each follow-up visit.
Measured: Baseline to 2 years
The visual scale score during the 2-year follow-up
Visual scale score measured by the Chinese version of the pediatric refractive error profile 2 (PREP2) and is scaled from 0 (poor quality of life) to 100 (good quality of life)
Measured: Baseline to 2 years
The best corrected visual acuity (BCVA) during the 2-year follow-up
BCVA will be measured by EDTRS visual acuity chart.
Measured: Baseline to 2 years
The subjective perception score during the 2-year follow-up
Subjective perception score will be measured by questionnaire to test the comfort of wearing spectacles.
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start23 Mar 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Youyan Vision Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jian Ge, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264361
- Sponsor's protocol ID
- 2025KYPJ105
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenwald SH, Kuchenbecker JA, Rowlan JS, Neitz J, Neitz M. Role of a Dual Splicing and Amino Acid Code in Myopia, Cone Dysfunction and Cone Dystrophy Associated with L/M Opsin Interchange Mutations. Transl Vis Sci Technol. 2017 May 10;6(3):2. doi: 10.1167/tvst.6.3.2. eCollection 2017 May.
PubMed 28516000Gupta V, Saxena R, Dhiman R, Phuljhele S, Sharma N. Comparative evaluation of different (peripheral defocus based) spectacle designs in preventing myopia progression: A double-blinded randomised clinical trial. Ophthalmic Physiol Opt. 2025 Sep;45(6):1505-1511. doi: 10.1111/opo.13548. Epub 2025 Jun 24.
PubMed 40552434Wang M, Ma R, Kuang L, Chen X, Vincent SJ, Tan H, Lai Z, Xu S, Hu Y, Han M, Chen Q, Wang Z, Li L, Yang X. Myopia Control Efficacy of Asymmetric Multipoint Defocus Technique Spectacle Lenses: One-Year Double-Masked Randomized Controlled Trial. Ophthalmology. 2025 Sep;132(9):972-979. doi: 10.1016/j.ophtha.2025.04.022. Epub 2025 Apr 28.
PubMed 40306584Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
PubMed 35357402Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29.
PubMed 31142465Bullimore MA, Saunders KJ, Baraas RC, Berntsen DA, Chen Z, Chia AWL, Goto S, Jiang J, Lan W, Logan NS, Najjar RP, Polling JR, Read SA, Woodman-Pieterse EC, Szell N, Verkicharla PK, Wu PC, Zhu X, Loughman J, Nagra M, Phillips JR, Tran HDM, Vera-Diaz FA, Yam J, Liu YM, Singh SE, Wildsoet CF. IMI-Interventions for Controlling Myopia Onset and Progression 2025. Invest Ophthalmol Vis Sci. 2025 Sep 2;66(12):39. doi: 10.1167/iovs.66.12.39.
PubMed 40960225Hu Y, Ding X, Guo X, Chen Y, Zhang J, He M. Association of Age at Myopia Onset With Risk of High Myopia in Adulthood in a 12-Year Follow-up of a Chinese Cohort. JAMA Ophthalmol. 2020 Nov 1;138(11):1129-1134. doi: 10.1001/jamaophthalmol.2020.3451.
PubMed 32940622Chen Z, Gu D, Wang B, Kang P, Watt K, Yang Z, Zhou X. Significant myopic shift over time: Sixteen-year trends in overall refraction and age of myopia onset among Chinese children, with a focus on ages 4-6 years. J Glob Health. 2023 Nov 9;13:04144. doi: 10.7189/jogh.13.04144.
PubMed 37934967Pan Z, Xian H, Li F, Wang Z, Li Z, Huang Y, Liu W, Li Y, Li F, Wang J, Chen H, Wu Y, Xu Y, Wu G, Zhang Y, He L, Zhang J, Zhang F, Qian X, Zhang X, Zhou L, Feng Y, Li L, He X, Xu X, Yang J, Zhou X, Zhu D, Pan C, Ang M, Saw SM, Zheng Y, He M, Jonas JB, Bressler NM, Cheng CY, Tham YC, Zhang C, Wang YX, Wong TY. Myopia and high myopia trends in Chinese children and adolescents over 25 years: a nationwide study with projections to 2050. Lancet Reg Health West Pac. 2025 Jun 11;59:101577. doi: 10.1016/j.lanwpc.2025.101577. eCollection 2025 Jun.
PubMed 40568343Holden 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