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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: D.D.C dual-control technology spcetacle lenses; Device: Aspheric single-vision lenses

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yangfa Zeng; Phone Number: +86-020-6686986; Email: zengyangfa@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; D.D.C dual-control technology spectacle lenses	Device: D.D.C dual-control technology spcetacle lenses; 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.
Experimental: Control; Aspheric single-vision spectacle lenes	Device: Aspheric single-vision lenses; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up	Change in cycloplegic SER (Diopter) from baseline to 12 months.	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	Baseline to 2 years
Spectacle wear compliance	Spectacle wearing time, assessed at each follow-up visit.	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)	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.	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.	Baseline to 2 years

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: Guangzhou Youyan Vision Technology Co., Ltd.
• Investigators: Principal Investigator: Jian Ge, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• Lam 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.
• 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.
• Gupta 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.
• Wang 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.
• Bao 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.
• Bullimore 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.
• Hu 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.
• Chen 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.
• Pan 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 4, 2025

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: Myopia control; Defocus diffusion composite technology
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: 2025KYPJ105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No