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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-lens zoning myopia defocus Lens 1 (D.S.D.O) | Experimental |
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| Multi-lens zoning myopia defocus Lens 2(D.S.D.O) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses | Device | 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. Lens Design 2. Participants are required to wear the assigned spectacles daily for the entire 12-month study duration, except during sleep or other unavoidable circumstances. The spectacles are intended to provide full refractive correction for distance vision while simultaneously incorporating defocus modifications designed to slow myopia progression by manipulating peripheral retinal defocus patterns. The study includes a baseline visit, a dispensing visit, and follow-up assessments at 3, 6, 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent Refraction (SER) | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | China |
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Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
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