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Clinical Trials in China / NCT07264361
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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 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2026-03-23
Last updated
2026-07-28

Condition(s) studied

Myopia, Progressive

Investigational drug(s) / intervention(s)

D.D.C dual-control technology spcetacle lensesAspheric single-vision lenses

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
12 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07264361 on ClinicalTrials.gov ↗ ← All trials in China