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Идёт набор NCT06523504

Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control

Фаза I / Фаза II С лечением Myopia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: DIMS, The 0.02% ATP Group, The 0.04% ATP Group, 0.02%ATP+DIMS.
Кому может быть актуально
Состояния в реестре: Myopia. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control

Обзор

To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

Подробное описание

In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.

Вмешательства

  • Устройство DIMS
    wear DIMS ,and use placebo,once nightly, both eye
  • Препарат The 0.02% ATP Group
    wear SP, and use 0.02%ATP eye drops, once nightly, both eye
  • Препарат The 0.04% ATP Group
    wear SP, and use 0.04%ATP eye drops, once nightly, both eye
  • Комбинированный продукт 0.02%ATP+DIMS
    wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
  • Комбинированный продукт 0.04%ATP+DIMS
    wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

Первичные конечные точки

  • Best Corrected Visual Acuity [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

  • School-age children aged 6 to 12 years (including boundary value)
  • Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
  • Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
  • Agree with the study scheme and sign the informed consent
  • Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.

Критерии исключения

  • Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
  • Children with obvious strabismus and amblyopia
  • With congenital eye disease, such as congenital cataract, congenital retinal disease
  • Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
  • Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
  • Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
  • Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg)
  • Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
  • Optic nerve damage or congenital optic nerve dysfunction
  • Can not be regularly checked
  • The adjustment range is less than 8D or obvious near difficulties
  • Other reasons researchers think it is not suitable for inclusion in researchers

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Tianjin Medical University Eye Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06523504 · 2019yj001J-5 · 2019yj001J-5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗