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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Lisa A Jordan, PhD
- Telefonnummer: 614-247-7321
- E-post: jordan.646@osu.edu
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- University of Alabama School of Optometry
-
Kontakt:
- Sindhu Gurrala
- Telefonnummer: 205-975-3881
- E-post: OPT-donutstudy@uab.edu
-
-
California
-
Berkeley, California, Förenta staterna, 94720
- Rekrytering
- University of California, Berkeley, School of Optometry
-
Kontakt:
- Yoofi Mensah
- Telefonnummer: 510-207-4758
- E-post: donut@berkeley.edu
-
Fullerton, California, Förenta staterna, 92831
- Rekrytering
- Southern California College of Optometry at Marshall B. Ketchum University
-
Kontakt:
- Susan Parker
- Telefonnummer: 714-463-7580
- E-post: research@ketchum.edu
-
Palo Alto, California, Förenta staterna, 94303
- Rekrytering
- Stanford University
-
Kontakt:
- Joellen Leonard
- Telefonnummer: 650-498-0842
- E-post: Robertsvisionlab@stanford.edu
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60616
- Rekrytering
- Illinois College of Optometry
-
Kontakt:
- Jessica Martinez
- Telefonnummer: 312-949-7340
- E-post: Research@ico.edu
-
-
Indiana
-
Bloomington, Indiana, Förenta staterna, 47405
- Rekrytering
- Indiana University
-
Kontakt:
- Amy Peterson, OD
- Telefonnummer: 812-856-0242
- E-post: peteramy@iu.edu
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- New England College of Optometry
-
Kontakt:
- Tamara Khanjyan
- Telefonnummer: 617-587-5723
- E-post: donutstudy@neco.edu
-
-
New York
-
New York, New York, Förenta staterna, 10036
- Rekrytering
- State University of New York College of Optometry
-
Kontakt:
- Keyana Hunte
- Telefonnummer: 212-938-4052
- E-post: clinicresearch@sunyopt.edu
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Har inte rekryterat ännu
- Case Western Reserve Department of Ophthalmology
-
Kontakt:
- Adam J Peiffer, OD
- Telefonnummer: 440-684-1743
- E-post: adam.peiffer@uhhospitals.org
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- The Ohio State University College of Optometry
-
Kontakt:
- Alexis Koston
- Telefonnummer: 614-292-0200
- E-post: OPT-DonutStudy@osu.edu
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Pennsylvania
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Elkins Park, Pennsylvania, Förenta staterna, 19027
- Rekrytering
- Pennsylvania College of Optometry at Drexel University
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Kontakt:
- Asami Kojima
- Telefonnummer: 215-276-6053
- E-post: donutstudy@drexel.edu
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- Rekrytering
- Southern College of Optometry
-
Kontakt:
- Elaine Turcotte
- Telefonnummer: 901-730-5004
- E-post: eturcotte@sco.edu
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Texas
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Houston, Texas, Förenta staterna, 77004
- Rekrytering
- University of Houston College of Optometry
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Kontakt:
- Onose Okoeguale
- Telefonnummer: 713-743-1994
- E-post: donut@uh.edu
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime |
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy |
|
Placebo-jämförare: Placebo
Placebo drops instilled in each eye nightly at bedtime |
Placebo drop with same formulation as treatment minus the atropine |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
Tidsram: Two years
|
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo |
Two years
|
|
Axial elongation (by Myopia Master)
Tidsram: Two years
|
Axial elongation comparison between treatment and placebo |
Two years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
Tidsram: 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)
Tidsram: 2 years
|
Spherical equivalent progression (change) comparison between treatment and placebo |
2 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- 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
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DONUTCT
- UG1EY037202 (U.S.S. NIH-anslag/kontrakt)
- UG1EY037201 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
Data will be available for access on Vivli.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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