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

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Single Vision Spectacle Lens
Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia, axial length, DIMS

Eligibility Criteria

6 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: progressive myopia - Exclusion Criteria: ocular pathology, amblyopia, strabism -

Sites / Locations

  • Czech Technical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Vision Spectacle Lens

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Arm Description

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

Participants who chose to correct myopia with DIMS spectacle lenses.

Outcomes

Primary Outcome Measures

Axial length of eye
biometry (Lenstar 900)

Secondary Outcome Measures

Objective refraction
autorefractometer (Huwitz)

Full Information

First Posted
July 4, 2023
Last Updated
July 4, 2023
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05943912
Brief Title
Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
Official Title
Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
October 10, 2026 (Anticipated)
Study Completion Date
December 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. We observe 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, axial length, DIMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
on decision of participant
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Vision Spectacle Lens
Arm Type
Experimental
Arm Description
Participants who chose to correct myopia with single vision spectacle lenses.
Arm Title
Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
Arm Type
Experimental
Arm Description
Participants who chose to correct myopia with DIMS spectacle lenses.
Intervention Type
Other
Intervention Name(s)
Single Vision Spectacle Lens
Intervention Description
36 months of therapy
Intervention Type
Other
Intervention Name(s)
Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
Intervention Description
36 months of therapy
Primary Outcome Measure Information:
Title
Axial length of eye
Description
biometry (Lenstar 900)
Time Frame
in 36 moths therapy
Secondary Outcome Measure Information:
Title
Objective refraction
Description
autorefractometer (Huwitz)
Time Frame
in 36 month therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: progressive myopia - Exclusion Criteria: ocular pathology, amblyopia, strabism -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marketa Zakova, Ph.D.
Phone
+420604578004
Email
marketa.zakova@fbmi.cvut.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marketa Zakova, Ph.D.
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Study Director
Facility Information:
Facility Name
Czech Technical University
City
Prague
State/Province
Czech Republic
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marketa Zakova, Ph.D.
Phone
+420604578004
Email
marketa.zakova@fbmi.cvut.cz

12. IPD Sharing Statement

Learn more about this trial

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

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