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Active Not RecruitingNCT05943912

Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Czech Technical University in Prague · Academic / Other
Sex
All
Age
6 Years – 26 Years
Healthy volunteers
Not accepted

Summary

The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.

Detailed description

The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes). Defocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15. The majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes. The goals of our study: * compare the efficacy of DIMS spectacle lenses with SV spectacle lenses at slowing the progression of myopia in the category of Czech children and young adults (effect on axial length and refractive changes) * monitoring axial length and refractive changes in myopic children and young adults (aged 6-26) * monitoring adaptation to DIMS lenses in myopes aged 6-26 years monitoring the influence of the environment and individual behavior on the progression of myopia

Conditions

Interventions

TypeNameDescription
OTHERSingle Vision Spectacle Lens36 months of therapy
OTHERDefocus Incorporated Multiple Segments (DIMS) Spectacle Lens36 months of therapy

Timeline

Start date
2023-04-17
Primary completion
2026-10-10
Completion
2026-12-12
First posted
2023-07-13
Last updated
2024-04-02

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT05943912. Inclusion in this directory is not an endorsement.