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Active, not recruitingNCT05943912Updated Apr 2, 2024

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

An observational study in Myopia, sponsored by Czech Technical University in Prague. Active, not recruiting at 1 site in Czechia. Open to participants aged 6 Years to 26 Years. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Czech Technical University in Prague · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
6 Years to 26 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Myopia

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Keywords

  • myopia
  • axial length
  • DIMS
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 80 is below the median of 150 across 173 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

To evaluate the efficacy of Defocus Incorporated Multiple Segment (DIMS) lenses in slowing myopia progression in a young European population of progressing myopes. A prospective, non-randomized, observational 3 - year study will be conducted in 80 progressing myopes aged 6-26 years, with myopia between -0,25D and -8,5D and astigmatism -0,25 and -2,25DC. Participants self-selected wearing DIMS (n=55) or single vision (SV) lenses (n=25). Spherical Equivalent Refraction (SER, cycloplegic autorefraction) and axial length (AL) were measured at baseline. AL will be measured at 3M, 6M and every 6M and SER will be measured every 12M.

Inclusion criteria

  • Progressive myopia
  • Myopes aged 6-26 years
  • Myopia between -0,25D and -8,5D
  • Astigmatism -0,25 and -2,25DC

Exclusion criteria

Exclusion Criteria:

  • Ocular pathology
  • Amblyopia
  • Strabism
  • Non-compliance to eye examinations
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Single Vision Spectacle Lens

    Participants who chose to correct myopia with single vision spectacle lenses.

    Other: Single Vision Spectacle Lens

  • Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

    Participants who chose to correct myopia with DIMS spectacle lenses.

    Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Interventions

  • OtherSingle Vision Spectacle Lens

    36 months of therapy

  • OtherDefocus Incorporated Multiple Segments (DIMS) Spectacle Lens

    36 months of therapy

06

What researchers measure

Primary outcomes

  1. Axial length of eye

    biometry (Lenstar 900)

    Time frame: in 36 moths therapy

Secondary outcomes

  1. Objective refraction

    autorefractometer (Huwitz)

    Time frame: in 36 month therapy

07

Study locations

1 site
  • Czech Technical University
    Prague, Czech Republic, Czechia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05943912
Lead sponsor
Czech Technical University in Prague
Responsible party
Sponsor
First posted
Jul 13, 2023
Start date
Apr 17, 2023
Primary completion
Oct 10, 2026 (estimated)
Completion
Dec 12, 2026 (estimated)
Last update
Apr 2, 2024

Study contacts

Marketa Zakova, Ph.D.
study director · Czech Technical University in Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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