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

March 29, 2024 updated by: Czech Technical University in Prague
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Prague, Czech Republic, Czechia
        • Czech Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Vision Spectacle Lens
Participants who chose to correct myopia with single vision spectacle lenses.
Other: Single Vision Spectacle Lens
36 months of therapy
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
36 months of therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length of eye
Time Frame: in 36 moths therapy
biometry (Lenstar 900)
in 36 moths therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective refraction
Time Frame: in 36 month therapy
autorefractometer (Huwitz)
in 36 month therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Investigators

  • Study Director: Marketa Zakova, Ph.D., Czech Technical University in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

December 12, 2026

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGS23/195/OHK4/3T/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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