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NCT Number: NCT07264361

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia, Progressive Eye Diseases Myopia Myopia, Degenerative Refractive Errors

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up

    Time frame: Baseline to 1 year

    Change in cycloplegic SER (Diopter) from baseline to 12 months.

Secondary outcomes

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

    Time frame: Baseline to 1 year

    Changes in AL (mm) from baseline to 1, 6, and 12 months. AL will be measured using the IOLMaster 700 before cycloplegia.

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

    Time frame: Baseline to 1 year

    Change in cycloplegic SER (Diopter) from baseline to 1 and 6 months.

  3. Changes in corneal curvature during the 1-year follow-up

    Time frame: Baseline to 1 year

    Changes in corneal curvature (mm) from baseline to 1, 6, and 12 months. Corneal curvature will be measured by IOL Master-700 before cycloplegia.

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

    Time frame: Baseline to 1 year

    Changes in ACD (mm) from baseline to 1, 6, and 12 months. ACD will be measured by IOL Master-700 before cycloplegia.

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

    Time frame: Baseline to 1 year

    Changes in LT (mm) from baseline to 1, 6, and 12 months. LT will be measured by IOL Master-700 before cycloplegia.

  6. Changes in spherical equivalent refraction (SER) at all time points from the 12-month follow-up during the 12-24 month follow-up period

    Time frame: 1 year to 2 years

    Changes in cyclopegic SER (Diopter) from 12 months to 13, 18, and 24 months.

  7. Changes in axial length (AL) from the 12-month follow-up during the 12-24 month follow-up period

    Time frame: 1 year to 2 years

    Changes in AL (mm) from 12 months to 13, 18, and 24 months. AL will be measured using the IOL Master 700 before cyclopegia.

  8. Changes in corneal curvature from the 12-month follow-up during the 12-24 month follow-up period

    Time frame: 1 year to 2 years

    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.

  9. Changes in anterior chamber depth (ACD) from the 12-month follow-up during the 12-24 month follow-up period

    Time frame: 1 year to 2 years

    Changes in ACD (mm) from 12 months to 13, 18, and 24 months. ACD will be measured by IOL Master-700 before cyclopegia.

  10. Changes in lens thickness (LT) from the 12-month follow-up during the 12-24 month follow-up period

    Time frame: 1 year to 2 years

    Changes in LT (mm) from 12 months to 13, 18, and 24 months. LT will be measured by IOL Master-700 before cyclopegia.

  11. Change in choroidal thickness from baseline to the 1-month follow-up

    Time frame: Baseline to 1 month

    Change in choroidal thickness (μm) from baseline to 1 months.

  12. Change in choroidal thickness from the 12-month to the 13-month follow-up

    Time frame: 1 year to 13 months

    Change in choroidal thickness (μm) from the 12 months to the 13 months.

  13. The proportion of participants who experienced clinically significant myopia progression

    Time frame: Baseline to 2 years

    The proportion of participants who experienced clinically significant myopia progression (>0.5D/year) during the two-year follow-up

  14. Spectacle wear compliance

    Time frame: Baseline to 2 years

    Spectacle wearing time, assessed at each follow-up visit.

  15. The visual scale score during the 2-year follow-up

    Time frame: Baseline to 2 years

    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)

  16. The best corrected visual acuity (BCVA) during the 2-year follow-up

    Time frame: Baseline to 2 years

    BCVA will be measured by EDTRS visual acuity chart.

  17. The subjective perception score during the 2-year follow-up

    Time frame: Baseline to 2 years

    Subjective perception score will be measured by questionnaire to test the comfort of wearing spectacles.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Collaborators

  • Guangzhou Youyan Vision Technology Co., Ltd.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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