NCT02767856终止不适用
Intense vs Standard Regimens of Intermittent Occlusion Therapy for Unilateral Moderate Amblyopia in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Visual Acuity Improvement
研究概览
简要总结
This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?
Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following criteria must be met for the patient to be enrolled in the study:
- •Age 3 to < 8 years
- •Unilateral amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- •Criteria for strabismus: At least one of the following criteria must be met:
- •Heterotropia at distance and/or near fixation on examination (with or without spectacles)
- •History of strabismus surgery
- •Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- •Criteria for anisometropia: At least one of the following criteria must be met:
- •>0.50 D difference between eyes in spherical equivalent
- •>0.50 D difference between eyes in astigmatism in any meridian
- •Amblyopic eye has no myopia (> -0.25 D spherical equivalent).
- •Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- •Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- •Visual acuity in the sound eye 20/32 or better
- •Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity)
- •No previous amblyopia treatment within 6 months.
- •Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
- •Requirements for spectacle correction:
- •For patients meeting criteria for only strabismus
- •Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
- •For patients meeting criteria for anisometropia or combined-mechanism
- •Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
- •Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes
- •Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
- •Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
- •Spectacles meeting above criteria must be worn either:
- •for 4 weeks immediately prior to enrollment, or
- •until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements at least 4 weeks apart with no improvement of one line or more)
- •An acuity measurement done any of the following ways may be considered the first of two consecutive measurements:
- •in current glasses,
- •in trial frames with full correction of hypermetropia with cycloplegia, or
- •in new glasses.
- •Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
- •Ocular examination within 6 months prior to enrollment.
- •Gestational age > 34 weeks and birth weight > 1500 grams
- •Parent willing to accept randomization
- •Parent willing to be contacted and has access to phone
- •Parent does not anticipate relocation outside area within study period.
排除标准
- •Amblyopic eye has myopia worse than -3.00 D spherical equivalent.
- •Prior intraocular or refractive surgery
- •Ocular pathologies that impact vision
- •Cognitive impairment that prohibits accurate data collection
研究组 & 干预措施
Intense 12-hour IO-therapy Group
Experimental
Participants wear 12-hour daily IO-therapy glasses for 4 weeks
干预措施: IO-therapy Glasses (Device)
Standard 4-hour IO-therapy Group
Active Comparator
Participants wear 4-hour daily IO-therapy glasses for 12 weeks
干预措施: IO-therapy Glasses (Device)
结局指标
主要结局
Visual Acuity Improvement
时间窗: 4 weeks for the Intense Group and 12 weeks for the Standard Group
visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
次要结局
- Objective Adherence(4 weeks for the Intense Group and 12 weeks for the Standard Group)
- Stereoacuity Test(4 weeks for the Intense Group and 12 weeks for the Standard Group)
- Objective Total Treatment Hours(4 weeks for the Intense Group and 12 weeks for the Standard Group)
研究者
研究点 (1)
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