MyopiaNCT06556849
Effectiveness of DIMS Spectacle as a Function of the Age
An observational study of Myopia, run by Luca Buzzonetti at 1 site in Italy.
Trial summary
Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients. Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Myopia
- What is being tested?
- Defocus Incorporated Multiple Segments (DIMS)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients with documented progressive myopiua
Who may be able to join
- patient age between 6-16 years
- progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
- astigmatism less than 2.50D, anisometropia under 1.25D
Who cannot join
- genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
- systemic diseases
- eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Defocus Incorporated Multiple Segments in Slowing Myopia Progression as a Function of the Age in Pediatric Patients. Three Years Follow up.
Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).
Read the detailed description
Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Multiple Segments (DIMS)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus Incorporated Multiple Segments (DIMS)Device
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| Group A: patients oldest than 10 years that wear DIMS lens | myopic patients oldest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles Receives: Device: Defocus Incorporated Multiple Segments (DIMS) | |
| Group B: patients oldest than 10 years that wear (control group) | myopic patients oldest than 10 years of age that wore single vision spectacle lenses (control group) Receives: Device: Defocus Incorporated Multiple Segments (DIMS) | |
| Group C: patients youngest than 10 years that wear DIMS lens | myopic patients youngest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles Receives: Device: Defocus Incorporated Multiple Segments (DIMS) | |
| Group D: patients youngest than 10 years (control group) | myopic patients youngest than 10 years of age that wore single vision spectacle lenses (control group) Receives: Device: Defocus Incorporated Multiple Segments (DIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SE
spherical equivalent
Measured: 36 months
Secondary outcomes (1)
AL
axial lenght
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Dec 2020
- Primary completion1 Dec 2020
- Study completion30 Jun 2024
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luca Buzzonetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
- Investigators
- Luca Buzzonetti, Principal investigator, Bambino Gesù IRCCS Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556849
- Sponsor's protocol ID
- Myopia1
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Defocus Incorporated Multiple Segments in Slowing Myopia Progression as a Function of the Age in Pediatric Patients. Three Years Follow up.
- ClinicalTrials.gov ID
- NCT06556849
- Acronym / sponsor ID
- Myopia1
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Luca BuzzonettiUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Aug 2024 (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.
Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).
Detailed description
Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: patients oldest than 10 years that wear DIMS lens | – | Device: Defocus Incorporated Multiple Segments (DIMS)myopic patients oldest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles |
| Group B: patients oldest than 10 years that wear (control group) | – | Device: Defocus Incorporated Multiple Segments (DIMS)myopic patients oldest than 10 years of age that wore single vision spectacle lenses (control group) |
| Group C: patients youngest than 10 years that wear DIMS lens | – | Device: Defocus Incorporated Multiple Segments (DIMS)myopic patients youngest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles |
| Group D: patients youngest than 10 years (control group) | – | Device: Defocus Incorporated Multiple Segments (DIMS)myopic patients youngest than 10 years of age that wore single vision spectacle lenses (control group) |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients with documented progressive myopiua
Key inclusion criteria (3 listed)
- patient age between 6-16 years
- progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
- astigmatism less than 2.50D, anisometropia under 1.25D
Key exclusion criteria (3 listed)
- genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
- systemic diseases
- eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)
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 |
|---|---|---|
| Defocus Incorporated Multiple Segments (DIMS)To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients. | Device | Group A: patients oldest than 10 years that wear DIMS lens, Group B: patients oldest than 10 years that wear (control group), Group C: patients youngest than 10 years that wear DIMS lens, Group D: patients youngest than 10 years (control group) |
Primary outcome
SE
Time frame: 36 months
spherical equivalent
1 secondary outcome
AL
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
Luca Buzzonetti principal investigator
Bambino Gesù IRCCS Children's Hospital
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 Luca Buzzonetti at 1 site in Italy.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Aug 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SE (time frame: 36 months). 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 20 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.