Objective Assessment of Disparity Vergence After Treatment of Symptomatic Convergence Insufficiency (CI) in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
研究概览
简要总结
This study is designed to evaluate changes in objective measures of disparity vergence after office-based vergence/accommodative therapy (OBVAT) for convergence insufficiency (CI) in children 12-17 years old.
详细描述
30 participants with normal binocular vision and 30 with CI will be recruited for this prospective study. All participants with CI will be treated with 12 weeks of office-based vergence/accommodative therapy. The primary outcome measure will be the average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence will be time to peak velocity, latency, and accuracy. Changes in clinical measures [near point of convergence (NPC), positive fusional vergence at near (PFV)] and symptoms will be evaluated.
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
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CI Symptom Survey score ≥ 16
- •Exophoria at near at least 4 greater than at far
- •Receded near point of convergence (NPC) of 6 cm break
- •Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's criterion or PFV ≤15 base-out break)
- •Best-corrected distance visual acuity of 20/25 or better in each eye
- •Random dot stereopsis appreciation of 500 seconds of arc or better
- •Wearing appropriate refractive correction (spectacles of contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)
- •No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
排除标准
- •Constant strabismus at distance or near
- •Esophoria of ≥ 2∆ at distance
- •Vertical heterophoria ≥ 2∆ at distance or near
- •≥ 2 line interocular difference in best-corrected visual acuity
- •Near point of accommodation >20 cm in either eye as measured by push-up method
- •Manifest or latent nystagmus
- •History of strabismus surgery or refractive surgery
- •CI associated with head trauma or known disease of the brain
- •Diseases known to affect accommodation, vergence, or ocular motility
- •Inability to comprehend and/or perform any study-related test
结局指标
主要结局
Change in average peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy
时间窗: After 12 weeks of therapy
The ISCAN RK-826PCI binocular tracking system (Burlington, MA) will be used used to objectively record horizontal vergence eye movements. Five parameters will be measured with this instrument and the primary outcome measures will be the change in average peak velocity for 4° symmetrical convergence steps
次要结局
- Change in latency for 4° symmetrical convergence steps after 12 weeks of therapy(After 12 weeks of therapy)
- Change in the near point of convergence(After 12 weeks of therapy)
- Change in time to peak velocity for 4° symmetrical convergence steps after 12 weeks of therapy(After 12 weeks of therapy)
- Change in accuracy for 4° symmetrical convergence steps after 12 weeks of therapy(After 12 weeks of therapy)
- Change in settling time for 4° symmetrical convergence steps after 12 weeks of therapy(After 12 weeks of therapy)
- Change in the positive fusional vergence(After 12 weeks of therapy)
研究者
Mitchell Scheiman
Dean of Research
Salus University