Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses.
- Who it may be relevant to
- Registry conditions: Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus, Visual Quality. Basic parameters: 6 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Clinical Trial The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are: Do D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression. Participants will: Wear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations). Attend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations. Maintain a diary recording daily wear time, visual symptoms, and any adverse events.
Interventions
- Device Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses
This clinical trial employs a randomized, parallel-group, superiority design to evaluate two novel optical designs of Diverse Segments Defocus Optimization (D.S.D.O.) myopia management spectacle lenses. A total of 60 myopic Chinese children, aged 6 to 14 years, will be recruited and randomly assigned in a 1:1 ratio to one of two intervention groups. Both groups will receive myopia control spectacles: the Control Group will use D.S.D.O. Lens Design 1, and the Intervention Group will use D.S.D.O.
Primary outcome measures
- Change in Spherical Equivalent Refraction (SER) [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital — Beijing
Identifiers
NCT: NCT07323251 · TREC2024-KY161