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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:
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:
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.
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:
Exclusion criteria:
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:
The study aims to answer the following questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myopic cohort | Inclusion Criteria:
Exclusion criteria:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing myopia-control D.I.M.S. glasses while awake | Device | DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | up to 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24 week |
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Inclusion Criteria:
• Participants must be between 6 and 15 years of age at the start of myopia progression treatment
Exclusion Criteria:
• Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoltan Zs Nagy, Professor | Contact | +3614591500 | szem.titkarsag@gmail.com | |
| Amarilla Barcsay-Veres | Contact | +3614591500 | veres.amarilla@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Zoltan Zs Nagy, Professor | Semmelweis University Ophthalmology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Ophthalmology Department | Recruiting | Budapest | 1085 | Hungary |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007909 | Lenses |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| DIMS (Defocus Incorporated Multiple Segments) lenses | Device | 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. |
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