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Clinical Trials/NCT05943912
NCT05943912
Active, not recruiting
Not Applicable

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

Czech Technical University in Prague1 site in 1 country80 target enrollmentApril 17, 2023
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Czech Technical University in Prague
Enrollment
80
Locations
1
Primary Endpoint
Axial length of eye
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
December 12, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Non-compliance to eye examinations

Outcomes

Primary Outcomes

Axial length of eye

Time Frame: in 36 moths therapy

biometry (Lenstar 900)

Secondary Outcomes

  • Objective refraction(in 36 month therapy)

Study Sites (1)

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