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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
Aspheric single-vision spectacle lenes
干预措施: Aspheric single-vision lenses (Device)
Intervention
D.D.C dual-control technology spectacle lenses
干预措施: D.D.C dual-control technology spcetacle lenses (Device)
结局指标
主要结局
Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up
时间窗: Baseline to 1 year
Change in cycloplegic SER (Diopter) from baseline to 12 months.
次要结局
- Changes in anterior chamber depth (ACD) during the 1-year follow-up(Baseline to 1 year)
- Changes in axial length (AL) from the 12-month follow-up during the 12-24 month follow-up period(1 year to 2 years)
- Change in choroidal thickness from baseline to the 1-month follow-up(Baseline to 1 month)
- Change in choroidal thickness from the 12-month to the 13-month follow-up(1 year to 13 months)
- Changes in spherical equivalent refraction (SER) from baseline during the 1-year follow-up, excluding the 12-month time point.(Baseline to 1 year)
- Changes in corneal curvature during the 1-year follow-up(Baseline to 1 year)
- Changes in axial length (AL) during the 1-year follow-up(Baseline to 1 year)
- Changes in lens thickness (LT) during the 1-year follow-up(Baseline to 1 year)
- Changes in spherical equivalent refraction (SER) at all time points from the 12-month follow-up during the 12-24 month follow-up period(1 year to 2 years)
- Changes in corneal curvature from the 12-month follow-up during the 12-24 month follow-up period(1 year to 2 years)
- Changes in anterior chamber depth (ACD) from the 12-month follow-up during the 12-24 month follow-up period(1 year to 2 years)
- Changes in lens thickness (LT) from the 12-month follow-up during the 12-24 month follow-up period(1 year to 2 years)
- The best corrected visual acuity (BCVA) during the 2-year follow-up(Baseline to 2 years)
- The subjective perception score during the 2-year follow-up(Baseline to 2 years)
- The proportion of participants who experienced clinically significant myopia progression(Baseline to 2 years)
- Spectacle wear compliance(Baseline to 2 years)
- The visual scale score during the 2-year follow-up(Baseline to 2 years)