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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

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

316 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhongshan Ophthalmic Center, Sun Yat-sen University

Lead sponsor

Guangzhou Youyan Vision Technology Co., Ltd.

Collaborator