Highly Aspherical Lenslet (HAL) and Binocular Vision (BV) Disorders [HALT X(T) Study]

Обзор

Assess the effect and changes of eye misalignment (strabismus) with myopia control glasses Assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children

Подробное описание

Studies have been done to show that spectacles, atropine eye drops, and outdoor activities have some efficacy in slowing myopia progression in children, however most of such studies exclude children with significant eye conditions such as strabismus or nystagmus to isolate the effects of myopia control treatment. In this study, we would like to investigate whether these specialized glasses can effectively slow down the progression of myopia in children with strabismus. Since strabismus can affect visual development, this study would also be able to assess the effect and changes of eye misalignment (strabismus) with myopia control glasses. The study also aims to assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children.

Вмешательства

• Устройство HAL lenses for children with strabismus
  It has been shown that peripheral segmented defocus spectacles can slow myopia progression. The Essilor® Stellest™ lens has been designed with an exclusive and pioneering technology called HALT (Highly Aspherical Lenslet Target). The HALT technology is made of a constellation of 1,021 invisible lenslets. This constellation creates a signal in front of the retina that acts as a shield against eye elongation and, therefore, myopia progression. Studies suggest that children are tolerable against th
• Устройство SVL for children with strabismus
  SVL for children with strabismus

Первичные конечные точки

• To assess the efficacy of HAL lenses in childhood myopia control in children with strabismus and nystagmus [Срок оценки: 2 years]

Вторичные конечные точки (1)

• To assess the effect on strabismus (subjectively and functionally) over first vs second 6m [Срок оценки: 2 years]

Критерии участия

Критерии включения

Age 5-12 years old Myopia of between -1D and -6D in at least 1 eye Progression of at least 0.5D within the last year Astigmatism less than 2.5D Exotropia Exophoria: horizontal deviation <40PD Esotropia (good control), Esophoria: horizontal deviation <40PD Any vertical strabismus: Vertical deviation <10 PD Intermittent exotropia (good, moderate, poor) Horizontal deviation ≥15 PD, vertical deviation ≤5 PD (?)

Критерии исключения

VA poorer than logMAR 0.2 (6/9.5) in either eye Any other ocular condition (e.g. lens opacity, glaucoma) other than myopia, strabismus or nystagmus) Any medical/neurological condition which would interfere with subjects ability to co-operate with tests and attend follow-up appointments.

Plans of surgery for strabismus or nystagmus in the next year Constant XT). Past use of any other from of myopia control treatment (eg. atropine or myopia control glasses or contact lenses) within the last year.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Singapore National Eye Centre — Singapore

Идентификаторы

NCT: NCT06863675 · SingaporeNEC_HALTXT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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