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

NCT ID: NCT05943912

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2026-12-12

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

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Vision Spectacle Lens

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

Single Vision Spectacle Lens

Intervention Type: OTHER

36 months of therapy

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Participants who chose to correct myopia with DIMS spectacle lenses.

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Intervention Type: OTHER

36 months of therapy

Interventions

Single Vision Spectacle Lens

36 months of therapy

Intervention Type: OTHER

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

36 months of therapy

Intervention Type: OTHER

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
• Strabism
• Non-compliance to eye examinations

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marketa Zakova, Ph.D.

Role: STUDY_DIRECTOR

Czech Technical University in Prague

Locations

Czech Technical University

Prague, Czech Republic, Czechia

Countries

Czechia

Other Identifiers

SGS23/195/OHK4/3T/17

Identifier Type: -

Identifier Source: org_study_id