Myopia Clinical Trial
Official title:
Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial involving 50 subjects in each treatment arm (100 patients in total). The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
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