Myopia ProgressionNCT07092072
Efficacy and Tolerance of Full Field Peripheral Defocus Spectacles for the Control of Myopia Progression (Myofix Study)
A study testing MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE in people with Myopia Progression, run by Novar Corporation at 1 site in Argentina.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of the use of a new model of spectacles designed to control the progression of myopia in childhood. School myopia in children is mainly produced by increased ocular growth. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Myopia Progression
- What is being tested?
- MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteArgentina
- Study dates
- 23 May 2023to 23 Apr 2024
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 to 16 years who voluntarily agreed to use the Defocus spectacles for one year.
- A consecutive series of children diagnosed with myopia, attending accredited private practice ophthalmology clinics across Argentina.
- Absence of ocular pathology other than myopia,
- Spherical equivalent (SE = sphere + [cylinder/2]) between ≤-0.50 D and -5.00 D
- Astigmatism less than -2.00 D
- Anisometropia less than -1.00 D
- Keratometry less than 47.00 D in the steepest meridian
- The corrected distance visual acuity based on subjective refraction was required to be 0.1 logMAR (20/25 Feet Snellen) or better in each eye.
Who cannot join
- Myopia with onset before the age of 6 years,
- Any genetic syndromes,
- Current medical treatment for myopia other than single vision spectacle correction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-year Efficacy and Tolerance of Myofix Spectacles for the Control of Myopia Progression
The purpose of this study is to evaluate the efficacy and tolerability of the use of a new model of spectacles designed to control the progression of myopia in childhood. School myopia in children is mainly produced by increased ocular growth. This new spectacle design is based in the fact that positive lenses in front of eyes produce changes that decrease ocular growth. It consists of a full field peripheral positive defocus lens and a central section for the distance correction. The study is designed to evaluate tolerance and efficacy of this new lens in myopic children along a two year period.
Read the detailed description
The Myofix Defocus Study is a longitudinal, prospective, interventional, non-randomized research study intended to evaluate the tolerability and effectiveness of the use of spectacles with special design to control the progression of myopia during childhood. This field study included children aged 8 to 15 years old who voluntarily agreed to use the Defocus Spectacles for one year. A pair of spectacles (Myofix, Novar, Argentina) with frames (Usual, Argentina) were provided free of charge to all children studied for one year with the special addendum of peripheral defocus treatment. Children are instructed to wear the glasses the whole day every day of the week including Saturdays and Sundays.The Argentinian Defocus Spectacle lens design preserves the principle of the original design presented by Carly Lam et al., which consisted of a 9 mm central zone for distance correction and a +3.50 diopters defocus correction ring of lenslets laying between 9 and 32 mm diameter to act primarily on the para foveal zone that detects the defocus that governs the growth of the eye. Instead of micro peripheral defocus lenses in the 32 mm diameter ring zone with treatment, our model has a uniform peripheral +/+3.50 diopters power zone add. As it is known that 30-40 minutes of exposure to myopic defocus modifies the axial length (measured with Lenstar) by approximately 10-15 microns due to changes in choroidal thickness, the national design has been tested on 17 volunteer subjects showing a significant change of 11 microns shortening in the axial length of their eyes, such that that pilot study suggested the lenses could be effective in arresting the progression of myopia, as changes in the choroid are the first events in the retinal message that manages ocular growth. For comparing the outcomes of this study two virtual control groups in American children will be considered. One control group will be taken from a study in US giving children diluted atropine drops for myopia control. The placebo treated arm of this group will be considered. The other control group will be a cohort of children followed up in Argentina with cycloplegic refractions one year before the pandemic closeup began.
- Conditions
- Myopia Progression
- Being tested
- MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE
- Keywords
- Myopia control spectacles, full field defocus design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLEDevice
This is a plus peripheral add spectacle with the central part for the myopic correction.
| Study group | Role | What they receive |
|---|---|---|
| MYOPIA TREATED | Experimental | MYOPIC CHILDREN TREATED WITH MYOFIX SPECTACLES Receives: Device: MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
RATE OF MYOPIA PROGRESSION IN DIOPTERS
THE AMOUNT OF DIOPTERS OF MYOPIC PROGRESSION IN ONE YEAR FOLLOW UP MEASURED WITH CYCLOPLEGIC REFRACTIONS
Measured: 12 MONTHS AND 24 MONTHS FOLLOW UP PLANNED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start23 May 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myopia ProgressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novar Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092072
- Sponsor's protocol ID
- Registration No. 8638/23
- Other IDs
- Registration No. 8638
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are plans to share individual participant data if any investigator in the area of myopia control research asks us about the data.
Publications
De Tomas M, Kotlik C, Szeps A, Impagliazzo R, Iribarren R. New Spectacles for Myopia Control. Oftalmol Clin Exp. 2022; 15: 240-7.
Iribarren R SA, Kotlik C, Laurencio L, De Tomas M, Impagliazzo R, Martin G. Short-Term Axial Length Changes in Myopic Eyes Induced by Defocus Spectacles for Myopia Control. Photonics 2023; 10: 668.
De Tomás M SA, Martín G, Saracco G, Lanca C, Iribarren R. Effect of vertex distance in the treatment area of myopia control spectacles. Oftalmol Clin Exp 2024; 17: e547-e53.
Saracco G AM, De Tomás M, Martín G, Iribarren R. Development of a frame adaptation for myopia control spectacles. Oftalmol Clin Exp 2025; 18: e195-e201.
Szeps A KC, Fernández Irigaray L, Saracco G, De Tomas M, Martin G, Iribarren R. Baseline data in the study on the tolerance and efficacy of peripheral defocus spectacles for the control of myopia progression in Argentina (Myofix Defocus Study). Oftalmol Clin Exp 2024; 17: 352-8.
Iribarren R, Szeps A, Kotlik C, de Tomas M, Martin G, Rozema J, Lanca C. One-Year Efficacy and Tolerance of Myofix Defocus Spectacles for Control of Myopia Progression. Ophthalmol Ther. 2026 Jan;15(1):253-271. doi: 10.1007/s40123-025-01270-4. Epub 2025 Nov 12.
PubMed 41222872
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Efficacy and Tolerance of Myofix Spectacles for the Control of Myopia Progression
- ClinicalTrials.gov ID
- NCT07092072
- Acronym / sponsor ID
- Registration No. 8638/23
- Conditions
- Myopia Progression
- Keywords
- Myopia control spectacles, full field defocus design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novar CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 29 Jul 2025 (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 purpose of this study is to evaluate the efficacy and tolerability of the use of a new model of spectacles designed to control the progression of myopia in childhood. School myopia in children is mainly produced by increased ocular growth. This new spectacle design is based in the fact that positive lenses in front of eyes produce changes that decrease ocular growth. It consists of a full field peripheral positive defocus lens and a central section for the distance correction. The study is designed to evaluate tolerance and efficacy of this new lens in myopic children along a two year period.
Detailed description
The Myofix Defocus Study is a longitudinal, prospective, interventional, non-randomized research study intended to evaluate the tolerability and effectiveness of the use of spectacles with special design to control the progression of myopia during childhood. This field study included children aged 8 to 15 years old who voluntarily agreed to use the Defocus Spectacles for one year. A pair of spectacles (Myofix, Novar, Argentina) with frames (Usual, Argentina) were provided free of charge to all children studied for one year with the special addendum of peripheral defocus treatment. Children are instructed to wear the glasses the whole day every day of the week including Saturdays and Sundays.The Argentinian Defocus Spectacle lens design preserves the principle of the original design presented by Carly Lam et al., which consisted of a 9 mm central zone for distance correction and a +3.50 diopters defocus correction ring of lenslets laying between 9 and 32 mm diameter to act primarily on the para foveal zone that detects the defocus that governs the growth of the eye. Instead of micro peripheral defocus lenses in the 32 mm diameter ring zone with treatment, our model has a uniform peripheral +/+3.50 diopters power zone add. As it is known that 30-40 minutes of exposure to myopic defocus modifies the axial length (measured with Lenstar) by approximately 10-15 microns due to changes in choroidal thickness, the national design has been tested on 17 volunteer subjects showing a significant change of 11 microns shortening in the axial length of their eyes, such that that pilot study suggested the lenses could be effective in arresting the progression of myopia, as changes in the choroid are the first events in the retinal message that manages ocular growth. For comparing the outcomes of this study two virtual control groups in American children will be considered. One control group will be taken from a study in US giving children diluted atropine drops for myopia control. The placebo treated arm of this group will be considered. The other control group will be a cohort of children followed up in Argentina with cycloplegic refractions one year before the pandemic closeup began.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MYOPIA TREATED | Experimental | Device: MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLEMYOPIC CHILDREN TREATED WITH MYOFIX SPECTACLES |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 7 to 16 years who voluntarily agreed to use the Defocus spectacles for one year.
- A consecutive series of children diagnosed with myopia, attending accredited private practice ophthalmology clinics across Argentina.
- Absence of ocular pathology other than myopia,
- Spherical equivalent (SE = sphere + [cylinder/2]) between ≤-0.50 D and -5.00 D
- Astigmatism less than -2.00 D
Key exclusion criteria (3 listed)
- Myopia with onset before the age of 6 years,
- Any genetic syndromes,
- Current medical treatment for myopia other than single vision spectacle correction.
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 |
|---|---|---|
| MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLEThis is a plus peripheral add spectacle with the central part for the myopic correction. | Device | MYOPIA TREATED |
Primary outcome
RATE OF MYOPIA PROGRESSION IN DIOPTERS
Time frame: 12 MONTHS AND 24 MONTHS FOLLOW UP PLANNED
THE AMOUNT OF DIOPTERS OF MYOPIC PROGRESSION IN ONE YEAR FOLLOW UP MEASURED WITH CYCLOPLEGIC REFRACTIONS
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 29 Jul 2025.
- BackgroundDe Tomas M, Kotlik C, Szeps A, Impagliazzo R, Iribarren R. New Spectacles for Myopia Control. Oftalmol Clin Exp. 2022; 15: 240-7.
- BackgroundIribarren R SA, Kotlik C, Laurencio L, De Tomas M, Impagliazzo R, Martin G. Short-Term Axial Length Changes in Myopic Eyes Induced by Defocus Spectacles for Myopia Control. Photonics 2023; 10: 668.
- BackgroundDe Tomás M SA, Martín G, Saracco G, Lanca C, Iribarren R. Effect of vertex distance in the treatment area of myopia control spectacles. Oftalmol Clin Exp 2024; 17: e547-e53.
- BackgroundSaracco G AM, De Tomás M, Martín G, Iribarren R. Development of a frame adaptation for myopia control spectacles. Oftalmol Clin Exp 2025; 18: e195-e201.
- Results publicationSzeps A KC, Fernández Irigaray L, Saracco G, De Tomas M, Martin G, Iribarren R. Baseline data in the study on the tolerance and efficacy of peripheral defocus spectacles for the control of myopia progression in Argentina (Myofix Defocus Study). Oftalmol Clin Exp 2024; 17: 352-8.
- Derived from this study: PubMed 41222872Iribarren R, Szeps A, Kotlik C, de Tomas M, Martin G, Rozema J, Lanca C. One-Year Efficacy and Tolerance of Myofix Defocus Spectacles for Control of Myopia Progression. Ophthalmol Ther. 2026 Jan;15(1):253-271. doi: 10.1007/s40123-025-01270-4. Epub 2025 Nov 12.
- Individual participant dataSharing planned: Yes. There are plans to share individual participant data if any investigator in the area of myopia control research asks us about the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE in people with Myopia Progression, run by Novar Corporation at 1 site in Argentina.
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 8 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 29 Jul 2025. 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 Argentina. 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?
RATE OF MYOPIA PROGRESSION IN DIOPTERS (time frame: 12 MONTHS AND 24 MONTHS FOLLOW UP PLANNED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092072, which also lists 6 linked publications.
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 29 Jul 2025.