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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Myopia, Progressive

Treatments: Device: D.D.C dual-control technology spcetacle lenses; Device: Aspheric single-vision lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07264361

2025KYPJ105

Details and patient eligibility

About

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.

Enrollment: 316 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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316 participants in 2 patient groups

Intervention

Experimental group

Description:

D.D.C dual-control technology spectacle lenses

Treatment:

Device: D.D.C dual-control technology spcetacle lenses

Control

Experimental group

Description:

Aspheric single-vision spectacle lenes

Treatment:

Device: Aspheric single-vision lenses