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 with 2 arms, involving 111 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
111
Atropine 0,025% (1 drop per day)
Use of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances.
Use of monofocal lenses.
Noemi Guemes
Madrid, Madrid, Spain
Cycloplegic spherical equivalent refraction (SER) change
Cycloplegic spherical equivalent refraction (SER) change
Time frame: 2 years (24 months)
Axial length (AL) change
Axial length (AL) change
Time frame: 2 years (24 months)
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