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Inhibition of Myopia Progression With Optical Devices

7. juli 2026 opdateret af: Barcsay-Veres Amarilla, Semmelweis University

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. How does myopia progression change with age while wearing myopia progression control glasses?
  2. 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?
  3. 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. How does myopia progression change with age while wearing myopia progression control glasses?
  2. 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?
  3. 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Ungarn
      • Budapest, Ungarn, 1085
        • Rekruttering
        • Semmelweis University Ophthalmology Department
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Otto A Maneschg, PhD
        • Underforsker:
          • Amarilla Barcsay-Veres, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Enhed: Wearing myopia-control D.I.M.S. glasses while awake
DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
Enhed: DIMS (Defocus Incorporated Multiple Segments) lenses
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Best corrected visual acuity test
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stereopsis
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Semmelweis University

Efterforskere

  • Ledende efterforsker: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juni 2026

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

27. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SE-RKEB 222/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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