Inhibition of Myopia Progression With Optical Devices
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Zoltan Zs Nagy, Professor
- Telefonní číslo: +3614591500
- E-mail: szem.titkarsag@gmail.com
Studijní záloha kontaktů
- Jméno: Amarilla Barcsay-Veres
- Telefonní číslo: +3614591500
- E-mail: veres.amarilla@semmelweis.hu
Studijní místa
-
-
-
Budapest, Maďarsko, 1085
- Nábor
- Semmelweis University Ophthalmology Department
-
Kontakt:
- Zoltan Zs Nagy, Professor
- Telefonní číslo: +3614591500
- E-mail: szem.titkarsag@semmelweis.hu
-
Kontakt:
- Amarilla Barcsay-Veres, PhD
- Telefonní číslo: +3614591500
- E-mail: veres.amarilla@semmelweis.hu
-
Dílčí vyšetřovatel:
- Otto A Maneschg, PhD
-
Dílčí vyšetřovatel:
- Amarilla Barcsay-Veres, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Myopic cohort
Inclusion Criteria:
Exclusion criteria:
|
DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Best corrected visual acuity test
Časové okno: 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
|
up to 24 week
|
|
Bulbar axial length measurement
Časové okno: 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.
|
up to 24 week
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Stereopsis
Časové okno: up to 24 week
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SE-RKEB 222/2026
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