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

NCT07264361 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ105
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Defocus diffusion composite technology; Myopia control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Changes in axial length (AL) during the 1-year follow-up

  Baseline to 1 year

• Changes in spherical equivalent refraction (SER) from baseline during the 1-year follow-up, excluding the 12-month time point.

  Baseline to 1 year

• Changes in corneal curvature during the 1-year follow-up

  Baseline to 1 year

• Changes in anterior chamber depth (ACD) during the 1-year follow-up

  Baseline to 1 year

• Changes in lens thickness (LT) during the 1-year follow-up

  Baseline to 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

D.D.C dual-control technology spectacle lenses

Device: D.D.C dual-control technology spcetacle lenses

Control

EXPERIMENTAL

Aspheric single-vision spectacle lenes

Device: Aspheric single-vision lenses

Interventions

Aspheric single-vision lenses DEVICE

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.

Control

D.D.C dual-control technology spcetacle lenses DEVICE

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.

Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Inability to attend regular ophthalmic examinations.

Sponsors & Collaborators

• Guangzhou Youyan Vision Technology Co., Ltd.: collaborator
• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (10)

• 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.

  PMID: 28516000 RESULT

• 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.

  PMID: 40552434 RESULT

• 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.

  PMID: 40306584 RESULT

• 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.

  PMID: 35357402 RESULT

• 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.

  PMID: 31142465 RESULT

• 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.

  PMID: 40960225 RESULT

• 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.

  PMID: 32940622 RESULT

• 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.

  PMID: 37934967 RESULT

• 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.

  PMID: 40568343 RESULT

• 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.

  PMID: 26875007 RESULT

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Jian Ge

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangfa Zeng

CONTACT

+86-020-6686986; zengyangfa@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 4, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)