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.
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;
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;
Parallel
D.D.C dual-control technology spcetacle lenses
DeviceThe 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
DeviceThe 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.
Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up
Change in cycloplegic SER (Diopter) from baseline to 12 months.
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.
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.
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.
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.
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Guangzhou Youyan Vision Technology Co., Ltd.
Collaborator
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