Influence of Rodenstock Spectacle Lenses on Myopia Progression.

Официальное название

Testing the Efficacy of Rodenstock Spectacle Lenses in Myopia Progression: a Two Year Clinical Trial

Обзор

The prevalence of myopia in Singapore is among the highest in the world, with 65 percent of our children being myopic by Primary 6, and 83 percent of young adults being myopic. As such, Singapore is often labelled as the "Myopia Capital of the World". By 2050, it is projected that 80 to 90 per cent of all Singaporean adults above 18 years old will be myopic and 15 to 25 percent of these individuals may have high myopia. High myopia (spherical equivalent refraction ≤ -5 D) puts one at risk of many eye disorders later in life, such as early cataracts, glaucoma and macular degeneration. These complications often cause significant morbidity and may even be sight-threatening. Hence there is an urgent and growing need for synergistic efforts to counter myopia. The goal of this clinical trial is to test the efficacy of spectacle lenses in controlling the progression of myopia in children (aged 6-12 years) over a period of 2 years. In addition, this trial aims to evaluate the impact of these spectacle lenses on central visual performance and visual comfort. Therefore, in this randomised, double-masked clinical trial, one hundred and eighty-five (n=185) subjects aged 6-12 years with mild or moderate myopia (\< -5D) will be randomised in a 1:1 allocation ratio into three strata defined by age 6-8, 8-10 and 10-12 years to ensure age balance between the two arms (control group - single vision lenses and intervention group - myopia control lenses, gender matched). In the control group, after one year (12 months) of wearing single vision lenses, the children will switch to the myopia control lenses (crossover design).

Вмешательства

• Устройство Myopia control spectacle lens
  The intervention group will wear specially designed lenses that aim to slow the progression of myopia. Follow-up visits will take place at regular intervals.
• Устройство Single-vision lens
  The control group will wear single vision lenses for one year. They will then switch to the myopia control lens for a further year. Follow-up visits will take place at regular intervals.

Первичные конечные точки

• Spherical equivalent refraction [Срок оценки: 2 years]

Вторичные конечные точки (7)

• Axial length [Срок оценки: 2 years]
• Peripheral refraction [Срок оценки: 2 years]
• Choroidal thickness [Срок оценки: 2 years]
• Visual acuity [Срок оценки: 1 year]
• Contrast sensitivity [Срок оценки: 1 year]
• Visual comfort [Срок оценки: 1 year]
• Light exposure [Срок оценки: 2 years]

Критерии участия

Критерии включения

• All myopic children aged 6-12 years old
• Treatment naïve
• Sphere: -0.5 D till -5.00 D
• Anisometropia < 1.5D
• Astigmatism > -1.5D
• Monocular best corrected visual acuity +0.1 logMAR or better, and binocular visual acuity 0.0 logMAR or better

Критерии исключения

• On current myopia control treatments
• Any diagnosed ocular conditions besides myopia or astigmatism.
• No diagnosed ocularmotor conditions (Nystagmus, strabismus, etc.)
• Any diagnosed chronic physical or mental disabilities
• Contraindication in cycloplegia (high IOP, etc.)
• Corneal astigmatism > 1.5 D; irregular astigmatism

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• NUH — Singapore

Идентификаторы

NCT: NCT06816446 · CTS01245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗