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

19. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

664

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Rekruttering
        • University of Alabama School of Optometry
        • Ta kontakt med:
    • California
      • Berkeley, California, Forente stater, 94720
        • Rekruttering
        • University of California, Berkeley, School of Optometry
        • Ta kontakt med:
      • Fullerton, California, Forente stater, 92831
        • Rekruttering
        • Southern California College of Optometry at Marshall B. Ketchum University
        • Ta kontakt med:
      • Palo Alto, California, Forente stater, 94303
        • Har ikke rekruttert ennå
        • Stanford University
        • Ta kontakt med:
    • Illinois
      • Chicago, Illinois, Forente stater, 60616
        • Rekruttering
        • Illinois College of Optometry
        • Ta kontakt med:
    • Indiana
      • Bloomington, Indiana, Forente stater, 47405
        • Rekruttering
        • Indiana University
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Rekruttering
        • New England College of Optometry
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10036
        • Rekruttering
        • State University of New York College of Optometry
        • Ta kontakt med:
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Har ikke rekruttert ennå
        • Case Western Reserve Department of Ophthalmology
        • Ta kontakt med:
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • The Ohio State University College of Optometry
        • Ta kontakt med:
    • Pennsylvania
      • Elkins Park, Pennsylvania, Forente stater, 19027
        • Har ikke rekruttert ennå
        • Pennsylvania College of Optometry at Drexel University
        • Ta kontakt med:
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38104
        • Rekruttering
        • Southern College of Optometry
        • Ta kontakt med:
    • Texas
      • Houston, Texas, Forente stater, 77004
        • Rekruttering
        • University of Houston College of Optometry
        • Ta kontakt med:
          • Onose Okoeguale
          • Telefonnummer: 713-743-1994
          • E-post: donut@uh.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime
Legemiddel: 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
Legemiddel: Placebo
Placebo drop with same formulation as treatment minus the atropine

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ohio State University

Samarbeidspartnere

National Eye Institute (NEI)

Etterforskere

  • 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. mai 2026

Primær fullføring (Antatt)

15. mai 2028

Studiet fullført (Antatt)

15. mai 2028

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

Data will be available for access on Vivli.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere