Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 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 evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.
Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.
详细描述
Children ages 3 to < 8 years with severe/dense amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
Children ages 3 to < 8 years with deprivation amblyopia associated with congenital or developmental cataracts (visual acuity of 20/40 to 20/400 in the amblyopic eye) will be enrolled.
Children ages 3 to < 8 years with myopic anisometropic amblyopia will be enrolled into an intermittent occlusion therapy glasses (AmblyzTM) group.
According to visual acuity, they will receive one of two IO-therapy glasses treatment regimens: 1) If the amblyopic eye is between 20/40 to 20/80 inclusive, 4-hour IO-therapy glasses or 2) If the amblyopic eye is between 20/100 to 20/400 inclusive, the child will receive12-hour IO-therapy glasses.
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
- 否
入选标准
- •Age 3 to < 8 years
- •Amblyopia associated with strabismus, anisometropia, or both
- •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 20/100 and 20/400 inclusive
- •Visual acuity in the sound eye 20/32 or better
- •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 i. 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 i. Spherical equivalent must be within 0.50 D of fully correcting the anisometropia ii. Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes iii. Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism iv. Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
- •Wearing optimal spectacle correction for a minimum of 4 weeks at the time of 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 of active study site
排除标准
- •• Amblyopic eye has myopia worse than -3.00D spherical equivalent.
- •Previous amblyopia treatment within 6 months.
- •Prior intraocular or refractive surgery
- •Known skin reactions to patch or bandage adhesives
- •Systemic diseases that may cause reduced vision such as Down syndrome.
- •If patients are in the deprivation amblyopia category, the following criteria must be met for the patient to be enrolled in the study:
- •Age 3 to < 8 years
- •Amblyopia due to previous congenital or developmental cataract surgery.
- •Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- •a. Visual acuity in the amblyopic eye between 20/40 and 20/400 inclusive b. Visual acuity in the sound eye 20/32 or better c. Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 3 lines worse than sound eye acuity) d) Gestational age > 34 weeks and birth weight > 1500 grams e) Parent willing to be contacted and has access to phone.
- •If patients are enrolled in the myopic anisometropia amblyopia category, the following criteria must be met for the patients to be enrolled in the study.
- •Aged 3 to <8 years
- •Best-corrected VA in the amblyopic eye of 20/40 to 20/400 inclusive
- •Best-corrected VA in the fellow eye of 20/40 or better
- •Magnitude of myopic anisometropia of > 3.00 D
- •Intereye acuity difference of > 3 logMAR lines
- •Amblyopia associated with myopic anisometropia
- •Has been wearing optimal spectacle correction for a minimum of four weeks
结局指标
主要结局
Visual Acuity Improvement
时间窗: 12± 1 weeks after treatment
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
次要结局
未报告次要终点
研究者
Jingyun Wang
Assistant Professor
Salus University