Diverse-segment defocus spectacle lenses to slow childhood myopia
Official title: Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
Run by Beijing Tongren Hospital · NCT07323251 · Data updated 2026-11-12
This study will test whether two different diverse-segment defocus optimization (D.S.D.O.) spectacle lens designs can slow myopia progression in children aged 6–14.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 14 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | August 2, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07323251 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–14 with cycloplegic spherical equivalent between −0.75D and −4.00D, astigmatism and anisometropia ≤1.50D, good best-corrected visual acuity, no recent myopia-control treatment, and ability to comply with visits and daily spectacle wear.
✕Probably not a fit
Children with refractive errors outside the specified range, high astigmatism, ocular or systemic disease affecting vision, recent myopia-control treatment, poor compliance, or inability to attend regular clinic visits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children meeting the entry criteria will be assigned to wear one of two D.S.D.O. spectacle lens designs daily for 12 months and will record daily wear time and any visual symptoms in a diary. Clinic visits are scheduled at baseline and at 3, 6, 9, and 12 months for comprehensive eye exams. Primary outcomes include changes in cycloplegic refraction and axial length, and the study will also record adverse events related to lens wear. The trial compares the relative efficacy and safety of the two optical designs in controlling myopia progression over one year.
Why it matters
Potential benefit: If successful, these lenses could slow axial elongation and reduce myopia progression in school-age children, potentially lowering the risk of future vision complications.
How similar studies have gone: Related approaches such as multifocal contact lenses, orthokeratology, and peripheral-defocus spectacle lenses have shown modest to moderate slowing of myopia progression, while D.S.D.O. spectacle designs are a newer variant with more limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6-14 years * Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction) * Astigmatism ≤1.50D * Anisometropia ≤1.50D * Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles * Absence of organic ocular diseases * No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices * Voluntary participation in this clinical study and provision of signed informed consent Exclusion Criteria: * History of ocular trauma or surgery * Systemic diseases affecting visual function * Inability to cooperate with examinations * Poor compliance * Inability to adhere to wearing requirements and follow-up visits during the trial period
Where it's running
-
Beijing Tongren Hospital
Beijing, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.