MyopiaNCT05943912
Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
An observational study of Myopia, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 26 years
- Conditions the study is for
- Myopia
- What is being tested?
- Single Vision Spectacle Lens and Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Apr 2023to 12 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Progressive myopia
- Myopes aged 6-26 years
- Myopia between -0,25D and -8,5D
- Astigmatism -0,25 and -2,25DC
Who cannot join
- Ocular pathology
- Amblyopia
- Strabism
- Non-compliance to eye examinations
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Myopia
- Being tested
- Single Vision Spectacle Lens, Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens
- Keywords
- myopia, axial length, DIMS
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Vision Spectacle LensOther
36 months of therapy
Defocus Incorporated Multiple Segments (DIMS) Spectacle LensOther
36 months of therapy
| Study group | Role | What they receive |
|---|---|---|
| Single Vision Spectacle Lens | Participants who chose to correct myopia with single vision spectacle lenses. Receives: Other: Single Vision Spectacle Lens | |
| Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens | Participants who chose to correct myopia with DIMS spectacle lenses. Receives: Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length of eye
biometry (Lenstar 900)
Measured: in 36 moths therapy
Secondary outcomes (1)
Objective refraction
autorefractometer (Huwitz)
Measured: in 36 month therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start17 Apr 2023
- Primary completion10 Oct 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marketa Zakova, Ph.D., Study director, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943912
- Sponsor's protocol ID
- SGS23/195/OHK4/3T/17
- Status last verified
- Mar 2024
- First submitted
- 4 Jul 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
- ClinicalTrials.gov ID
- NCT05943912
- Acronym / sponsor ID
- SGS23/195/OHK4/3T/17
- Conditions
- Myopia
- Keywords
- myopia, axial length, DIMS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Vision Spectacle Lens | – | Other: Single Vision Spectacle LensParticipants who chose to correct myopia with single vision spectacle lenses. |
| Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens | – | Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle LensParticipants who chose to correct myopia with DIMS spectacle lenses. |
Who may qualify
- Ages
- 6 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- Progressive myopia
- Myopes aged 6-26 years
- Myopia between -0,25D and -8,5D
- Astigmatism -0,25 and -2,25DC
Key exclusion criteria (4 listed)
- Ocular pathology
- Amblyopia
- Strabism
- Non-compliance to eye examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Vision Spectacle Lens36 months of therapy | Other | Single Vision Spectacle Lens |
| Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens36 months of therapy | Other | Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens |
Primary outcome
Axial length of eye
Time frame: in 36 moths therapy
biometry (Lenstar 900)
1 secondary outcome
Objective refraction
Time frame: in 36 month therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marketa Zakova, Ph.D. study director
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length of eye (time frame: in 36 moths therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.