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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Atropine Sulfate 0.05% Oph Soln
  Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy
• Препарат Placebo
  Placebo drop with same formulation as treatment minus the atropine

Первичные конечные точки

• Cumulative incidence of myopia (spherical equivalent by Myopia Master) [Срок оценки: Two years]
• Axial elongation (by Myopia Master) [Срок оценки: Two years]

Вторичные конечные точки (2)

• Time to event in incident myopes (measured by spherical equivalent by Myopia Master) [Срок оценки: 2 years]
• Progression of spherical equivalent (by Myopia Master) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 14 центров

• University of Alabama School of Optometry — Birmingham
• University of California, Berkeley, School of Optometry — Berkeley
• Southern California College of Optometry at Marshall B. Ketchum University — Fullerton
• Stanford University — Palo Alto
• Illinois College of Optometry — Chicago
• Indiana University — Bloomington
• New England College of Optometry — Boston
• State University of New York College of Optometry — New York
• … и ещё 6 центров

Идентификаторы

NCT: NCT07567040 · DONUTCT · UG1EY037202 · UG1EY037201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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