Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses

Официальное название

Mobility Performance in Daily Activities Among Children Wearing Single Vision and Myopia Control Spectacle Lenses

Обзор

The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing single vision spectacle lenses (control) versus myopia control spectacle lenses (test).

Вмешательства

• Устройство Novel spectacle lens design
  Use of lenses may reduce the rate of progression of juvenile myopia
• Устройство Spectacle lenses
  Use of lenses may reduce the rate of progression of juvenile myopia

Первичные конечные точки

• Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response [Срок оценки: 2 months]
• Movement time: the time taken to complete the motor response after it has been initiated. [Срок оценки: 2 months]
• Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli. [Срок оценки: 2 months]

Вторичные конечные точки (1)

• Gait cycle events, such as initial foot contact with the ground and toe-off. It will be used to assess whether the type of eyewear affects natural gait patterns or mobility during peripheral vision tasks. [Срок оценки: 2 months]

Критерии участия

Критерии включения

A participant is eligible for inclusion in the study if they meet the following criteria:

• Are between the ages of 6 and 12 years of age (inclusive) at the time of informed consent/assent.
• Can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR).
• Have undergone a self-reported oculo-visual examination within the past two years.
• Have no active ocular disease.
• Are willing and able to adhere to instructions, study procedures, and maintain the appointment schedule.
• Have not previously worn or participated in myopia control contact lenses for more than one month and are not currently undergoing any form of myopia control treatment.
• The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Критерии исключения

A participant will be excluded from the study if they meet any of the following conditions:

• Have any systemic disease that affects ocular health.
• Are currently using or have used, within the past 7 days, any systemic or topical medications that may impact ocular health.
• Are currently using or have used any topical ophthalmic agents with anti-muscarinic properties within 7 days prior to enrollment or at any point during the study. This includes, but is not limited to, atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate, and homatropine.
• Have used any oral agents with anti-muscarinic properties for a chronic period (2 months or more) or short-term (within 7 days prior to enrollment). This includes, but is not limited to, gastrointestinal anti-spasmodic medications containing atropine, hyoscyamine, and dicyclomine.
• Have known developmental delays.
• Have participated in another clinical study in the last 7 days

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Midwestern University Arizona College of Optometry — Glendale

Идентификаторы

NCT: NCT07229352 · CPRO-2507-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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