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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Zoltan Zs Nagy, Professor
- Numer telefonu: +3614591500
- E-mail: szem.titkarsag@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Amarilla Barcsay-Veres
- Numer telefonu: +3614591500
- E-mail: veres.amarilla@semmelweis.hu
Lokalizacje studiów
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Budapest, Węgry, 1085
- Rekrutacyjny
- Semmelweis University Ophthalmology Department
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Kontakt:
- Zoltan Zs Nagy, Professor
- Numer telefonu: +3614591500
- E-mail: szem.titkarsag@semmelweis.hu
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Kontakt:
- Amarilla Barcsay-Veres, PhD
- Numer telefonu: +3614591500
- E-mail: veres.amarilla@semmelweis.hu
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Pod-śledczy:
- Otto A Maneschg, PhD
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Pod-śledczy:
- Amarilla Barcsay-Veres, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
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.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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Myopic cohort
Inclusion Criteria:
Exclusion criteria:
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Best corrected visual acuity test
Ramy czasowe: up to 24 week
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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
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up to 24 week
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Bulbar axial length measurement
Ramy czasowe: up to 24 week
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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.
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up to 24 week
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Stereopsis
Ramy czasowe: up to 24 week
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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.
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up to 24 week
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SE-RKEB 222/2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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