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Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial (DONUT)

6. maj 2026 opdateret af: Ohio State University
The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The "Delaying the Onset of Nearsightedness (DONUT) Study - Data Coordinating Center" is a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. It is a multicenter (14 clinic centers) randomized clinical trial of 606 children (recruited over two years) ages 6 to 11 years who are determine to be at high risk of myopia onset, as measured by cycloplegic autorefraction and age. The primary outcome is the two-year cumulative incidence of myopia. The second aim of this project will determine whether atropine is associated with slower axial elongation in children receiving nightly drops of atropine versus placebo.

Participants will be seen every six months for at least two years to determine the onset of myopia.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

664

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Ikke rekrutterer endnu
        • University of Alabama School of Optometry
        • Kontakt:
    • California
      • Berkeley, California, Forenede Stater, 94720
        • Ikke rekrutterer endnu
        • University of California, Berkeley, School of Optometry
        • Kontakt:
      • Fullerton, California, Forenede Stater, 92831
        • Ikke rekrutterer endnu
        • Southern California College of Optometry at Marshall B. Ketchum University
        • Kontakt:
      • Palo Alto, California, Forenede Stater, 94303
        • Ikke rekrutterer endnu
        • Stanford University
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60616
        • Ikke rekrutterer endnu
        • Illinois College of Optometry
        • Kontakt:
    • Indiana
      • Bloomington, Indiana, Forenede Stater, 47405
        • Ikke rekrutterer endnu
        • Indiana University
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Ikke rekrutterer endnu
        • New England College of Optometry
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10036
        • Ikke rekrutterer endnu
        • State University of New York College of Optometry
        • Kontakt:
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Ikke rekrutterer endnu
        • Case Western Reserve Department of Ophthalmology
        • Kontakt:
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University College of Optometry
        • Kontakt:
    • Pennsylvania
      • Elkins Park, Pennsylvania, Forenede Stater, 19027
        • Ikke rekrutterer endnu
        • Pennsylvania College of Optometry at Drexel University
        • Kontakt:
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • Ikke rekrutterer endnu
        • Southern College of Optometry
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77004
        • Ikke rekrutterer endnu
        • University of Houston College of Optometry
        • Kontakt:
      • San Antonio, Texas, Forenede Stater, 78229
        • Ikke rekrutterer endnu
        • Rosenberg College of Optometry at the University of Incarnate Word
        • Kontakt:

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

Ja

Beskrivelse

Inclusion Criteria:

  • Refractive Error (cycloplegic autorefraction, spherical equivalent, at least one eye, inclusive) 6 years: -0.74 D to +0.75 D 7 and 8 years: -0.74 D to +0.50 D 9 and 10 years: -0.74 D to +0.25 D 11 years: -0.74 D to plano
  • Neither eye has -0.75 D or more myopia, spherical component
  • Anisometropia: Less than 1.50 D difference between OD and OS, cycloplegic autorefraction, spherical equivalent
  • Astigmatism: Less than 1.50 DC in both eyes by cycloplegic autorefraction
  • Successfully complete run-in period: take at least 90% of unit dose artificial tears for 2 to 4 weeks (# of unit-dose vials used divided by # nights since baseline visit must equal 0.90 or greater)

Exclusion Criteria:

  • If Visit 2 (randomization visit) is not completed within 4 weeks of the baseline, eligibility visit.
  • Presence of strabismus (intermittent or constant) based on unilateral cover test at distance and near
  • Known allergy to atropine
  • Systemic issues that may affect accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson's disease, Down syndrome, etc.)
  • Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.)
  • Ocular surgery (e.g., cataracts, strabismus)
  • Any previous myopia prevention/control therapy (e.g., atropine, soft contact lenses, orthokeratology, myopia control spectacles, etc.) for more than one month
  • Pregnancy by self-report

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime
Medicin: Atropine Sulfate 0.05% Oph Soln
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
Placebo komparator: Placebo
Placebo drops instilled in each eye nightly at bedtime
Medicin: Placebo
Placebo drop with same formulation as treatment minus the atropine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Tidsramme: Two years
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Two years
Axial elongation (by Myopia Master)
Tidsramme: Two years
Axial elongation comparison between treatment and placebo
Two years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
Tidsramme: 2 years
A comparison of the time to myopia onset between the treatment and placebo groups
2 years
Progression of spherical equivalent (by Myopia Master)
Tidsramme: 2 years
Spherical equivalent progression (change) comparison between treatment and placebo
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Ohio State University

Samarbejdspartnere

National Eye Institute (NEI)

Efterforskere

  • Studiestol: David A Berntsen, OD PhD, University of Houston College of Optometry
  • Studiestol: Jeffrey J Walline, OD PhD, The Ohio State University College of Optometry

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 (Anslået)

6. maj 2026

Primær færdiggørelse (Anslået)

15. maj 2028

Studieafslutning (Anslået)

15. maj 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DONUTCT
  • UG1EY037202 (U.S. NIH-bevilling/kontrakt)
  • UG1EY037201 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The final dataset to be shared will include self-reported demographic and participant activity and compliance to treatment data from interviews with participants' parent or guardian, eye examination data, and refraction data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures such as providing only participant age and not providing clinical site of data collection will be used for data de-identification and sharing, and informed consent forms will reflect those plans. Calculated fields, rather than the component fields, will be available for a more accessible dataset.

IPD-delingstidsramme

Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the contribution of the data to Vivli.

IPD-delingsadgangskriterier

Data will be available for access on Vivli.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nærsynethed

Kliniske forsøg med Atropine Sulfate 0.05% Oph Soln

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Burundi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner