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NCT05943912 Clinical Trial

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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05943912
Other study ID # SGS23/195/OHK4/3T/17
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 17, 2023
Est. completion date December 12, 2026

Study information
Verified date March 2024
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date December 12, 2026
Est. primary completion date October 10, 2026
Accepts healthy volunteers No
Gender All
Age group 6 Years to 26 Years
Eligibility Inclusion Criteria: - Progressive myopia - Myopes aged 6-26 years - Myopia between -0,25D and -8,5D - Astigmatism -0,25 and -2,25DC Exclusion Criteria: - Ocular pathology - Amblyopia - Strabism - Non-compliance to eye examinations

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Single Vision Spectacle Lens
36 months of therapy
• Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
36 months of therapy

Locations
Country Name City State
Czechia Czech Technical University Prague Czech Republic

Sponsors (1)
Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Axial length of eye biometry (Lenstar 900) in 36 moths therapy
Secondary Objective refraction autorefractometer (Huwitz) in 36 month therapy
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