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Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years. — NISDO  

Myopia Clinical Trial

Official title:
Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) Versus Orthokerathology Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years. The Noninferiority NISDO Study.

Clinical Trial Summary

The purpose is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in Danish myopic children aged 6-12 years. It is a clinical randomized non-inferiority trial, where the participants are randomly assigned to either OKL or DIMS spectacles. The participants are followed during 18 months of therapy. The hypotheses: - There is no statistically significant difference between the myopia control efficacy between OKL and DIMS spectacles. - Larger pupil size is positively correlated to treatment efficacy for both devises. - Increasing choroidal thickness during early treatment is positively correlated to treatment efficacy for both devises. - There is no difference in vision related quality of life between the two groups.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05134935
Study type Interventional
Source Vejle Hospital
Contact Lou-Ann Andersen
Phone +45 79 40 64 50
Email Lou-Ann.C.Andersen@rsyd.dk
Status Recruiting
Phase N/A
Start date June 29, 2022
Completion date May 2025
View Details
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