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Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control
Sponsor: Hospital San Carlos, Madrid
Summary
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.
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.
Key Details
Gender
All
Age Range
4 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
111
Start Date
2022-02-23
Completion Date
2026-06-30
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
Atropine 0,025%
Atropine 0,025% (1 drop per day)
DIMS Lenses
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.
Monofocal lenses
Use of monofocal lenses.
Locations (1)
Noemi Guemes
Madrid, Madrid, Spain