A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
研究概览
简要总结
The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled, single-masked, clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency (CI)
详细描述
Considerable controversy exists regarding the best treatment for convergence insufficiency (CI), a common condition that often interferes with the ability to perform near work. The two most widely used treatments have significant differences in costs and in practitioner perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which patients are prescribed a single procedure to perform at home with only periodic follow-up. Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and costly treatment in which patients are scheduled for weekly in-office therapy visits and are often prescribed a specific sequence of therapeutic procedures to perform at home. It is important to consider whether either, neither, or both treatments are effective.
The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner, multi-center clinical trial in which patients are randomized to one of these two treatment approaches. The primary goal is to answer the following question:
After 12 weeks of treatment, is one therapy more effective than the other in improving CI signs and symptoms? We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations.
The primary outcome measure will be a classification of each patient as a "success," "improvement," or "failure." This classification will be based on the level of improvement in both the signs (near point of convergence and positive fusional vergence) and symptoms of CI.
Additional questions relate to longer term effects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 9 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 9-30 years
- •Best corrected visual acuity of 20/25 in both eyes at distance and near
- •Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
- •Exophoria at near at least 4 prism diopters greater than at far
- •Insufficient positive fusional convergence (i.e., failing Sheard's criterion or minimum normative positive fusional vergence (PFV) of 15 base-out break).
- •Receded near point of convergence of > 6 cm break.
- •Normal random dot stereopsis using a 500 seconds of arc target.
- •CI Symptom Survey score > 16 for subjects in 9-18 year age range and > 21 for subjects in the 19-30 year age range.
- •Informed consent and willingness to participate in the study and be randomized
排除标准
- •CI previously treated with pencil push-ups (no more than 2 months of treatment within the past year)
- •CI previously treated with office-based vision therapy/orthoptics (no more than 2 months of treatment within the past year)
- •Amblyopia
- •Constant strabismus
- •History of strabismus surgery
- •Anisometropia >1.50D difference between eyes
- •Prior refractive surgery
- •Vertical heterophoria greater than 1
- •Systemic diseases known to affect accommodation, vergence, and ocular motility such as: multiple sclerosis, Graves's thyroid disease, myasthenia gravis, diabetes, and Parkinson disease
- •Any ocular or systemic medication known to affect accommodation or vergence
- •Monocular accommodative amplitude less than 4 D in either eye as measured by the Donder's push-up method
- •Manifest or latent nystagmus
- •Attention deficit hyperactivity disorder (ADHD) or learning disability diagnosis by parental report
- •Household member or sibling already enrolled in the CITT
- •Any eye care professional, technician, medical student, or optometry student
结局指标
主要结局
The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
次要结局
- Near Point of Convergence
- Positive Fusional Vergence at Near