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

Active, not recruiting

• Conditions: Myopia
• Interventions: Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens; Other: Single Vision Spectacle Lens

• Registration Number: NCT05943912
• Lead Sponsor: Czech Technical University in Prague

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

Study Timeline

• Study Start: 2023-04-17
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-10-10
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens	Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens	Participants who chose to correct myopia with DIMS spectacle lenses.
Single Vision Spectacle Lens	Single Vision Spectacle Lens	Participants who chose to correct myopia with single vision spectacle lenses.

Primary Outcome Measures

Name	Time	Method
Axial length of eye	in 36 moths therapy	biometry (Lenstar 900)

Secondary Outcome Measures

Name	Time	Method
Objective refraction	in 36 month therapy	autorefractometer (Huwitz)

Trial Locations

Locations (1)

Czech Technical University; 🇨🇿 Prague, Czech Republic, Czechia