A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Composite Measure of IXT Control Score
研究概览
简要总结
To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.
详细描述
Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children. Before surgery, many cases of IXT are treated using non-surgical interventions, such as part-time alternate occlusion. However, the "alternating" occlusion with traditional patches is usually out of control. The investigators are uncertain about the amount of "alternating" in patching treatment.
Here, the investigators introduce controlled intermittent alternating occlusion (CIAO) therapy, which is provided by a new electronic device, -liquid crystal glasses. This study is to determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old. Children with IXT will be randomized into either an observation group or a CIAO therapy group.
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
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent exotropia (manifest deviation) meeting all of the following criteria:
- •Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
- •Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
- •Exodeviation at least 10PD at distance measured by PACT
- •No previous surgical or non-surgical treatment for IXT (other than refractive correction)
- •Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
- •No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 7 years of age
- •Investigator not planning to initiate amblyopia treatment
- •No hyperopia greater than +3.50 D spherical equivalent in either eye
- •No myopia greater than -6.00 D spherical equivalent in either eye
- •No prior strabismus, intraocular, or refractive surgery
- •No abnormality of the cornea, lens, or central retina
- •Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met.
排除标准
- 未提供
研究组 & 干预措施
CIAO Therapy
Intervention with wearing 3-hour daily CIAO therapy glasses
干预措施: CIAO therapy Amblyz glasses (Device)
Observation
To observe as one kind of standard care for IXT.
结局指标
主要结局
Change in Composite Measure of IXT Control Score
时间窗: 12 weeks; 24 weeks
IXT control score: referring to the Pediatric eye disease investigator group (PEDIG). PEDIG scale of control for IXT 1-5 is defined as the following: 5 = Constant exotropia 4 = exotropia \> 50% of the 30-sec period before dissociation 3 = exotropia \< 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in \> 5 sec 1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in \< 1 sec (phoria) Not Applicable = No exotropia present
次要结局
未报告次要终点
研究者
Daniel E. Neely
Professor of Ophthalmology
Indiana University