Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial (DONUT)
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
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
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Lisa A Jordan, PhD
- Telefonnummer: 614-247-7321
- E-post: jordan.646@osu.edu
Studiesteder
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Alabama
-
Birmingham, Alabama, Forente stater, 35233
- Rekruttering
- University of Alabama School of Optometry
-
Ta kontakt med:
- Sindhu Gurrala
- Telefonnummer: 205-975-3881
- E-post: OPT-donutstudy@uab.edu
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California
-
Berkeley, California, Forente stater, 94720
- Rekruttering
- University of California, Berkeley, School of Optometry
-
Ta kontakt med:
- Yoofi Mensah
- Telefonnummer: 510-207-4758
- E-post: donut@berkeley.edu
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Fullerton, California, Forente stater, 92831
- Rekruttering
- Southern California College of Optometry at Marshall B. Ketchum University
-
Ta kontakt med:
- Susan Parker
- Telefonnummer: 714-463-7580
- E-post: research@ketchum.edu
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Palo Alto, California, Forente stater, 94303
- Rekruttering
- Stanford University
-
Ta kontakt med:
- Joellen Leonard
- Telefonnummer: 650-498-0842
- E-post: Robertsvisionlab@stanford.edu
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Illinois
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Chicago, Illinois, Forente stater, 60616
- Rekruttering
- Illinois College of Optometry
-
Ta kontakt med:
- Jessica Martinez
- Telefonnummer: 312-949-7340
- E-post: Research@ico.edu
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Indiana
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Bloomington, Indiana, Forente stater, 47405
- Rekruttering
- Indiana University
-
Ta kontakt med:
- Amy Peterson, OD
- Telefonnummer: 812-856-0242
- E-post: peteramy@iu.edu
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- New England College of Optometry
-
Ta kontakt med:
- Tamara Khanjyan
- Telefonnummer: 617-587-5723
- E-post: donutstudy@neco.edu
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New York
-
New York, New York, Forente stater, 10036
- Rekruttering
- State University of New York College of Optometry
-
Ta kontakt med:
- Keyana Hunte
- Telefonnummer: 212-938-4052
- E-post: clinicresearch@sunyopt.edu
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Har ikke rekruttert ennå
- Case Western Reserve Department of Ophthalmology
-
Ta kontakt med:
- Adam J Peiffer, OD
- Telefonnummer: 440-684-1743
- E-post: adam.peiffer@uhhospitals.org
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Columbus, Ohio, Forente stater, 43210
- Rekruttering
- The Ohio State University College of Optometry
-
Ta kontakt med:
- Alexis Koston
- Telefonnummer: 614-292-0200
- E-post: OPT-DonutStudy@osu.edu
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Pennsylvania
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Elkins Park, Pennsylvania, Forente stater, 19027
- Rekruttering
- Pennsylvania College of Optometry at Drexel University
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Ta kontakt med:
- Asami Kojima
- Telefonnummer: 215-276-6053
- E-post: donutstudy@drexel.edu
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Tennessee
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Memphis, Tennessee, Forente stater, 38104
- Rekruttering
- Southern College of Optometry
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Ta kontakt med:
- Elaine Turcotte
- Telefonnummer: 901-730-5004
- E-post: eturcotte@sco.edu
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Texas
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Houston, Texas, Forente stater, 77004
- Rekruttering
- University of Houston College of Optometry
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Ta kontakt med:
- Onose Okoeguale
- Telefonnummer: 713-743-1994
- E-post: donut@uh.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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 |
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy |
|
Placebo komparator: Placebo
Placebo drops instilled in each eye nightly at bedtime |
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
Sponsor
Samarbeidspartnere
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
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Øyesykdommer
- Brytningsfeil
- Nærsynthet
- Organiske kjemikalier
- Heterocykliske forbindelser
- Alkaloider
- AZA -forbindelser
- Heterocykliske forbindelser, overbygd ring
- Atropinderivater
- Tropaner
- Azabicyclo -forbindelser
- Belladonna -alkaloider
- Solanaceous alkaloider
- Bridged Bicyclo -forbindelser, heterocykliske
- Atropin
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)?
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
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