Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
研究概览
简要总结
This study evaluates the effect of 3D movie viewing on stereopsis recovery in anisometropic and / or strabismus amblyopia and the satisfaction with the intervention.
详细描述
Amblyopia is a visual neurodevelopmental disorder associated, more frequently, with the presence of strabismus and anisometropia. It is clinically most important visual condition in childhood because, apart from refractive error, it is the most frequent cause of vision loss in children. It is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development. Although amblyopia is expressed in the clinical practice as a reduction in visual acuity, it is also characterized by an altered stereoscopy. Generally, treatments for amblyopia focus on the recovery of visual acuity, and there are no treatments that focus mainly on the recovery of the altered stereopsis, so present and with an important functional impact.
The aim of this study reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia. On the one hand, to evaluate the effectiveness of viewing a 3D movie in the improvement of stereoacuity and the deviation, as well as visual acuity and sensitivity to contrast. Also, the correlation between them. On the other hand, to assess quantitatively the degree of satisfaction and acceptance of the participants and their families towards the intervention.
A quasi-experimental study will be performed, without a control group, pre- and post- intervention in which subjects with refractive and / or strabismus amblyopia, that have been subjected to traditional treatment for amblyopia, will be selected. Variables of stereopsis, latent or manifest deviation, visual acuity and sensitivity to the contrast will evaluate previously and after the intervention.
The sample will include subjects between 5 to 12 years old with a diagnosis of refractive and / or strabismic amblyopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of refractive and / or strabismus amblyopia at some point in life
- •History of amblyopia treatment completed at least 6 months before the intervention
- •Deviation angle equal to or less than 10 Dp
- •Absence of associated ophthalmological pathology.
排除标准
- •Ongoing amblyopia treatment;
- •Non-comitant and/or large constant strabismus (>10 prism diopters)
- •Any ocular pathological condition or nystagmus.
结局指标
主要结局
Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
时间窗: Baseline, immediately after intervention and 3 months
Stereopsis (ST in logMAR) will be evaluated by a TNO test.
Change from baseline latent or manifest deviation at 6m, immediately after intervention and 3 months studying the effect of viewing a 3D movie in the visual function.
时间窗: Baseline, immediately after intervention and 3 months
Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.
Change from baseline latent or manifest deviation at 40cm, after intervention at and 3 months studying the effect of viewing a 3D movie in the visual function.
时间窗: Baseline, immediately after intervention and 3 months
Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.
次要结局
- Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).(Immediately after intervention)