MyopiaATROSMARTNCT05062031
Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops
A study testing Defocus Incorporated Multiple Segments® (DIMS®) lenses, Atropine 0.05% eyedrops and Monofocal lenses in people with Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Myopia
- What is being tested?
- Defocus Incorporated Multiple Segments® (DIMS®) lenses, Atropine 0.05% eyedrops and Monofocal lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2021to 11 Feb 2026
- Phase
- Interventional
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of myopia - measured under cycloplegia - defined by:
- A sphere power between -1 and -6 Diopters, on at least one of the two eyes
- AND a cylindrical power strictly inferior to 2 Diopters
- AND a maximum refractive error strictly inferior to 8 Diopters in the flattest axis
- Not benefiting and never having benefited from a myopia control strategy (orthokeratology, soft defocusing lenses, low concentration atropine eye drops, peripheral defocusing corrective lenses)
- Written consent of both parents
Who cannot join
- History of genetic disease, or general condition suggesting a syndromic myopia (including an axial length greater than 27 mm)
- Strabismus
- Amblyopia defined by a best corrected visual acuity strictly inferior to 10/10 on one of the two eyes
- Anisometropia defined by a difference of 2 Diopters or more between the two eyes (in spherical equivalent)
- History of allergy to atropine
- History of severe anaphylaxis
Show all 9Show fewer
- Optical correction with contact lenses
- Previous ophthalmologic surgery of the cornea, lens, retina
- History of glaucoma or any other chronic ophthalmological disease in the course of treatment (including vernal keratoconjunctivitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Defocus Incorporated Multiple Segments® (DIMS®) Lenses Alone Versus Monofocal Lenses + Atropine 0.05% Eyedrops on the Evolution of Ocular Axial Length at 2 Years in Myopia Control in Children: Single-centre Prospective Randomised Controlled 1:1 Open-label Non-inferiority Study
Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.
Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.
The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Multiple Segments® (DIMS®) lenses, Atropine 0.05% eyedrops, Monofocal lenses
- Keywords
- Myopia, Pediatric ophthalmology, Myopia control, Defocus Incorporated Multiple Segments (DIMS) lenses, Low concentration atropine
- 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®) lensesDevice
Also called Miyosmart®
Daily wear for 24 months. Lenses have a central monofocal optical zone correcting spherical or spherocylindrical ametropia, surrounded by a ring made up of 300 defocusing pellets. This lens geometry reduces the phenomenon of blurred image projected in the retinal periphery, encountered when myopic eyes are corrected with monofocal lenses.
Atropine 0.05% eyedropsDrug
Also called Low-concentration atropine
One drop each evening in both eyes for 24 months.
Monofocal lensesDevice
Daily wear for 24 months
| Study group | Role | What they receive |
|---|---|---|
| DIMS® | Experimental | Defocus Incorporated Multiple Segments® lenses Receives: Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses |
| Low-concentration atropine + monofocal lenses | Active comparator | Not described Receives: Drug: Atropine 0.05% eyedrops; Device: Monofocal lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length measurements
Difference between the mean of 6 axial length measurements (in mm) acquired with the IOLMaster 500® at 24 months and the mean of 6 axial length measurements at inclusion
Measured: Inclusion, 24 months
Spherical equivalent
Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion
Measured: Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start19 Oct 2021
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Ecouter Voir, Hoya Lens France
- Responsible party
- Sponsor
- Investigators
- Gilles MARTIN, MD, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062031
- Sponsor's protocol ID
- GMN_2021_11
- Acronym
- ATROSMART
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2021
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Defocus Incorporated Multiple Segments® (DIMS®) Lenses Alone Versus Monofocal Lenses + Atropine 0.05% Eyedrops on the Evolution of Ocular Axial Length at 2 Years in Myopia Control in Children: Single-centre Prospective Randomised Controlled 1:1 Open-label Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05062031
- Acronym / sponsor ID
- ATROSMART / GMN_2021_11
- Conditions
- Myopia
- Keywords
- Myopia, Pediatric ophthalmology, Myopia control, Defocus Incorporated Multiple Segments (DIMS) lenses, Low concentration atropine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Ecouter Voir, Hoya Lens France
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 30 Sep 2021 (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.
Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.
Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.
The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIMS® | Experimental | Device: Defocus Incorporated Multiple Segments® (DIMS®) lensesDefocus Incorporated Multiple Segments® lenses |
| Low-concentration atropine + monofocal lenses | Active comparator | Drug: Atropine 0.05% eyedrops, Device: Monofocal lenses |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of myopia - measured under cycloplegia - defined by:
- Not benefiting and never having benefited from a myopia control strategy (orthokeratology, soft defocusing lenses, low concentration atropine eye drops, peripheral defocusing corrective lenses)
- Written consent of both parents
Key exclusion criteria (9 listed)
- History of genetic disease, or general condition suggesting a syndromic myopia (including an axial length greater than 27 mm)
- Strabismus
- Amblyopia defined by a best corrected visual acuity strictly inferior to 10/10 on one of the two eyes
- Anisometropia defined by a difference of 2 Diopters or more between the two eyes (in spherical equivalent)
- History of allergy to atropine
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®) lensesAlso: Miyosmart®Daily wear for 24 months. Lenses have a central monofocal optical zone correcting spherical or spherocylindrical ametropia, surrounded by a ring made up of 300 defocusing pellets. This lens geometry reduces the phenomenon of blurred image projected in the retinal periphery, encountered when myopic eyes are corrected with monofocal lenses. | Device | DIMS® |
| Atropine 0.05% eyedropsAlso: Low-concentration atropineOne drop each evening in both eyes for 24 months. | Drug | Low-concentration atropine + monofocal lenses |
| Monofocal lensesDaily wear for 24 months | Device | Low-concentration atropine + monofocal lenses |
Primary outcome
Axial length measurements
Time frame: Inclusion, 24 months
Difference between the mean of 6 axial length measurements (in mm) acquired with the IOLMaster 500® at 24 months and the mean of 6 axial length measurements at inclusion
Spherical equivalent
Time frame: Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months
Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion
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 21 Aug 2026.
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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.
Gilles MARTIN, MD principal investigator
Hôpital Fondation Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defocus Incorporated Multiple Segments® (DIMS®) lenses, Atropine 0.05% eyedrops and Monofocal lenses in people with Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 6 inclusion and 9 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 21 Aug 2026. 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 France. 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?
Axial length measurements (time frame: Inclusion, 24 months). The study lists 2 primary outcomes in all. 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 21 Aug 2026.