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NCT Number: NCT05943912

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Czech Technical University

Prague, Czech Republic, Czechia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Vision Spectacle Lens

Other

36 months of therapy

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Other

36 months of therapy

Primary outcomes

  1. Axial length of eye

    Time frame: in 36 moths therapy

    biometry (Lenstar 900)

Secondary outcomes

  1. Objective refraction

    Time frame: in 36 month therapy

    autorefractometer (Huwitz)

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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