Myopia, Progressive
Conditions
Keywords
Defocus diffusion composite technology, Myopia control
Brief summary
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.
Interventions
DEVICED.D.C dual-control technology spcetacle lenses
The 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.
DEVICEAspheric single-vision lenses
The 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.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou Youyan Vision Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spherical equivalent refraction (SER) from baseline to the 1-year follow-up | Baseline to 1 year | Change in cycloplegic SER (Diopter) from baseline to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in axial length (AL) during the 1-year follow-up | Baseline to 1 year | 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. | Baseline to 1 year | Change in cycloplegic SER (Diopter) from baseline to 1 and 6 months. |
| Changes in corneal curvature during the 1-year follow-up | Baseline to 1 year | 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 | Baseline to 1 year | Changes in ACD (mm) from baseline to 1, 6, and 12 months. ACD will be measured by IOL Master-700 before cycloplegia. |
| Changes in lens thickness (LT) during the 1-year follow-up | Baseline to 1 year | Changes in LT (mm) from baseline to 1, 6, and 12 months. LT will be measured by IOL Master-700 before cycloplegia. |
| 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 cyclopegic SER (Diopter) from 12 months to 13, 18, and 24 months. |
| Changes in axial length (AL) from the 12-month follow-up during the 12-24 month follow-up period | 1 year to 2 years | Changes in AL (mm) from 12 months to 13, 18, and 24 months. AL will be measured using the IOL Master 700 before cyclopegia. |
| 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 corneal curvature (mm) from 12 months to 13, 18, and 24 months. Corneal curvature will be measured by IOL Master-700 before cyclopegia. |
| 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 ACD (mm) from 12 months to 13, 18, and 24 months. ACD will be measured by IOL Master-700 before cyclopegia. |
| Changes in lens thickness (LT) from the 12-month follow-up during the 12-24 month follow-up period | 1 year to 2 years | Changes in LT (mm) from 12 months to 13, 18, and 24 months. LT will be measured by IOL Master-700 before cyclopegia. |
| Change in choroidal thickness from baseline to the 1-month follow-up | Baseline to 1 month | Change in choroidal thickness (μm) from baseline to 1 months. |
| Change in choroidal thickness from the 12-month to the 13-month follow-up | 1 year to 13 months | Change in choroidal thickness (μm) from the 12 months to the 13 months. |
| The proportion of participants who experienced clinically significant myopia progression | Baseline to 2 years | The proportion of participants who experienced clinically significant myopia progression (\>0.5D/year) during the two-year follow-up |
| Spectacle wear compliance | Baseline to 2 years | Spectacle wearing time, assessed at each follow-up visit. |
| The visual scale score during the 2-year follow-up | Baseline to 2 years | Visual scale score measured by the Chinese version of the pediatric refractive error profile 2 (PREP2) and is scaled from 0 (poor quality of life) to 100 (good quality of life) |
| The best corrected visual acuity (BCVA) during the 2-year follow-up | Baseline to 2 years | BCVA will be measured by EDTRS visual acuity chart. |
| The subjective perception score during the 2-year follow-up | Baseline to 2 years | Subjective perception score will be measured by questionnaire to test the comfort of wearing spectacles. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJian Ge
Zhongshan Ophthalmic Center, Sun Yat-sen University
Outcome results
None listed