Myopia ProgressionNCT07698977
Inhibition of Myopia Progression With Optical Devices
An observational study of Myopia Progression and Myopia, run by Semmelweis University at 1 site in Hungary.
Trial summary
This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population. The study aims to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Myopia Progression, Myopia, Myopia, Child Myopia Progression
- What is being tested?
- DIMS (Defocus Incorporated Multiple Segments) lenses
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 2 Jun 2026to 31 May 2027
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants (between 6 and 15 years of age) are wearing myopia progression treatment , namely D.I.M.S. lenses while they are awake. The wear these glasses to correct refractive error and to slow down myopia progression. At enrollment the refractive error measured under cycloplegia, expressed as spherical equivalent must be: between -0.50 Dsph and -10.0 Dsph.
Who may be able to join
- • Participants must be between 6 and 15 years of age at the start of myopia progression treatment
- Caucasian ethnicity
- Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
- Wearing myopia-control glasses while awake
- Participation in follow-up examinations every 6 months
Who cannot join
- • Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
- Premature birth before the 32nd week of gestation
- Previous eye-opening surgery (e.g., lens removal)
- Traumatic eye injury
- Known connective tissue disorder (e.g., Marfan syndrome)
- Irregular or improper use of progressive-lens glasses
- Failure to attend the follow-up examinations scheduled every 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Ophthalmology Department
Budapest, 1085
Zoltan Zs Nagy, Professor, +3614591500, szem.titkarsag@semmelweis.hu
Amarilla Barcsay-Veres, PhD, +3614591500, veres.amarilla@semmelweis.hu
About this study
This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population.
The study aims to answer the following questions:
Read more
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement
In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.
Read the detailed description
As an observational study we aim to examine the effects of D.I.M.S. lens's daily wear on myopia progression in relation to the environmental factors.
Our pediatric and adolescent myopic population is selected as follows:
Inclusion Criteria:
- Participants must be between 6 and 15 years of age at the start of myopia progression treatment
- Caucasian ethnicity
- Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
- Wearing myopia-control glasses during waking hours
- Willing to Participate in follow-up examinations up to 24 weeks
Exclusion criteria:
- pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
- preterm infants born before 32 weeks of gestation
- previous eye-opening surgery (e.g., lens extraction)
- Traumatic eye injury
- Known connective tissue disorder (e.g., Marfan syndrome)
- Irregular or improper use of progressive-lens glasses
- Failure to attend the follow-up examinations scheduled
In the self-controlled observational study the myopic participants are wearing during day time DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. DIMS glasses not only correct the refractive errror but also provide a circular defocus zone to avoid periferial retinal defocus.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time, subjective symptoms.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement These measurements and tests are part of the regular ophthalmological follow-up examinations.
The study aims to answer the following questions:
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? Statistical analysis plan includes non-parametric t-test, one way and two way ANOVA tests.
- Conditions
- Myopia Progression, Myopia, Myopia, Child Myopia Progression
- Being tested
- Wearing myopia-control D.I.M.S. glasses while awake, DIMS (Defocus Incorporated Multiple Segments) lenses
- Keywords
- myopia, myopia progression, optical device, DIMS lenses, bulbar axial length
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing myopia-control D.I.M.S. glasses while awakeDevice
DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
DIMS (Defocus Incorporated Multiple Segments) lensesDevice
D.I.M.S. lenses are worn like normal glasses to correct myopia and, beyond that, their special design is intended to slow myopia progression via defocus lenslets. There is targeted myopic defocus produced by the mid-peripheral lenslets with positive power to inhibit eye length growth.
| Study group | Role | What they receive |
|---|---|---|
| Myopic cohort | Inclusion Criteria:
* Participants must be between 6 and 15 years of age at the start of myopia progression treatment
* Caucasian ethnicity
* Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
* Wearing myopia-control glasses while awake
* Participation in follow-up examinations every 6 months
Exclusion criteria:
* Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
* Premature birth before the 32nd week of gestation
* Previous eye-opening surgery (e.g., lens removal)
* Traumatic eye injury
* Known connective tissue disorder (e.g., Marfan syndrome)
* Irregular or improper use of progressive-lens glasses
* Failure to attend the follow-up examinations scheduled every 6 months Receives: Device: Wearing myopia-control D.I.M.S. glasses while awake; Device: DIMS (Defocus Incorporated Multiple Segments) lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity test
Zero is equivalent to no vision and 1.0 indicates the best visual acuity in decimal scale. Distance and near visual acuity is measured under standard conditions
Measured: up to 24 week
Bulbar axial length measurement
It is defined as the distance from the anterior surface of the cornea to the retinal pigment epithelium, measured in millimeters using optical device. An increase in axial length is characteristic of the elongation of the eye.
Measured: up to 24 week
Secondary outcomes (1)
Stereopsis
stereopsis test (depth perception test) measures how well the eyes create three-dimensional vision. The precision of depth perception is measured in seconds of arc (arcsec) using a test plate. If stereoscopic vision is present, the smaller the angle, the more refined the stereopsis.
Measured: up to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Jun 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barcsay-Veres Amarilla, Semmelweis University
- Investigators
- Zoltan Zs Nagy, Professor, Principal investigator, Semmelweis University Ophthalmology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698977
- Sponsor's protocol ID
- SE-RKEB 222/2026
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Myopia Progression With Optical Devices
- ClinicalTrials.gov ID
- NCT07698977
- Acronym / sponsor ID
- SE-RKEB 222/2026
- Conditions
- Myopia Progression, Myopia, Myopia, Child Myopia Progression
- Keywords
- myopia, myopia progression, optical device, DIMS lenses, bulbar axial length
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population.
The study aims to answer the following questions:
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement
In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.
Detailed description
As an observational study we aim to examine the effects of D.I.M.S. lens's daily wear on myopia progression in relation to the environmental factors.
Our pediatric and adolescent myopic population is selected as follows:
Inclusion Criteria:
- Participants must be between 6 and 15 years of age at the start of myopia progression treatment
- Caucasian ethnicity
- Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph
- Wearing myopia-control glasses during waking hours
- Willing to Participate in follow-up examinations up to 24 weeks
Exclusion criteria:
- pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
- preterm infants born before 32 weeks of gestation
- previous eye-opening surgery (e.g., lens extraction)
- Traumatic eye injury
- Known connective tissue disorder (e.g., Marfan syndrome)
- Irregular or improper use of progressive-lens glasses
- Failure to attend the follow-up examinations scheduled
In the self-controlled observational study the myopic participants are wearing during day time DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. DIMS glasses not only correct the refractive errror but also provide a circular defocus zone to avoid periferial retinal defocus.
Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time, subjective symptoms.
Patients will visit the clinic once every six months for checkups and the following tests:
- Best corrected visual acuity test
- Stereopsis
- Automatic refractometry
- Bulbar axial length measurement These measurements and tests are part of the regular ophthalmological follow-up examinations.
The study aims to answer the following questions:
- How does myopia progression change with age while wearing myopia progression control glasses?
- How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account?
- How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? Statistical analysis plan includes non-parametric t-test, one way and two way ANOVA tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myopic cohort | – | Device: Wearing myopia-control D.I.M.S. glasses while awake, Device: DIMS (Defocus Incorporated Multiple Segments) lensesInclusion Criteria: * Participants must be between 6 and 15 years of age at the start of myopia progression treatment * Caucasian ethnicity * Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph * Wearing myopia-control glasses while awake * Participation in follow-up examinations every 6 months Exclusion criteria: * Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome) * Premature birth before the 32nd week of gestation * Previous eye-opening surgery (e.g., lens removal) * Traumatic eye injury * Known connective tissue disorder (e.g., Marfan syndrome) * Irregular or improper use of progressive-lens glasses * Failure to attend the follow-up examinations scheduled every 6 months |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants (between 6 and 15 years of age) are wearing myopia progression treatment , namely D.I.M.S. lenses while they are awake. The wear these glasses to correct refractive error and to slow down myopia progression. At enrollment the refractive error measured under cycloplegia, expressed as spherical equivalent must be: between -0.50 Dsph and -10.0 Dsph.
Key inclusion criteria (5 listed)
- • Participants must be between 6 and 15 years of age at the start of myopia progression treatment
Key exclusion criteria (7 listed)
- • Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
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 |
|---|---|---|
| Wearing myopia-control D.I.M.S. glasses while awakeDIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake | Device | Myopic cohort |
| DIMS (Defocus Incorporated Multiple Segments) lensesD.I.M.S. lenses are worn like normal glasses to correct myopia and, beyond that, their special design is intended to slow myopia progression via defocus lenslets. There is targeted myopic defocus produced by the mid-peripheral lenslets with positive power to inhibit eye length growth. | Device | Myopic cohort |
Primary outcome
Best corrected visual acuity test
Time frame: up to 24 week
Zero is equivalent to no vision and 1.0 indicates the best visual acuity in decimal scale. Distance and near visual acuity is measured under standard conditions
Bulbar axial length measurement
Time frame: up to 24 week
It is defined as the distance from the anterior surface of the cornea to the retinal pigment epithelium, measured in millimeters using optical device. An increase in axial length is characteristic of the elongation of the eye.
1 secondary outcome
Stereopsis
Time frame: up to 24 week
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zoltan Zs Nagy, Professor principal investigator
Semmelweis University Ophthalmology Department
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 Progression and Myopia, run by Semmelweis University at 1 site in Hungary.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Jul 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 Hungary. 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?
Contact Zoltan Zs Nagy, Professor (+3614591500, szem.titkarsag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity test (time frame: up to 24 week). 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 13 Jul 2026.