About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- D.D.C dual-control technology spcetacle lenses
- Aspheric single-vision lenses
Treatment groups
Sponsors and collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Guangzhou Youyan Vision Technology Co., Ltd.
Collaborator