NCT00347581已完成3 期
A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children
Pennsylvania College of Optometry19 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2003年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 19
- 主要终点
- Symptom score on the Convergence Insufficiency Symptom Survey
研究概览
简要总结
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.
详细描述
The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (CI).
The goals of this clinical trial are:
- To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment of CI in children
- To study the long-term effect of these treatments for CI
- To identify factors that may be associated with successful treatment of CI with base-in prism
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
- Double
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 9 to <19 years.
- •Best corrected visual acuity of ≥20/25 in each eye at distance and near
- •Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
- •Willingness to wear glasses for reading and other near work
- •Exophoria at near at least 4 greater than at far
- •Insufficient positive fusional convergence (fails Sheard's criterion)
- •Receded near point of convergence of 6 cm break
- •Random dot stereopsis appreciation using a 500 seconds of arc target.
- •CI Symptom Survey score 16
排除标准
- •Amblyopia (> 2 line difference in best corrected visual acuity between the two eyes).
- •Constant strabismus
- •History of strabismus surgery.
- •Anisometropia 2D in any meridian between the eyes.
- •Prior refractive surgery.
- •Vertical heterophoria greater than 1 .
- •Systemic diseases known to affect accommodation, vergence and ocular motility such as: multiple sclerosis, Graves thyroid disease, myasthenia gravis, diabetes, Parkinson disease.
- •Any ocular or systemic medication known to affect accommodation or vergence (Anti-anxiety agents (Librium or Valium), Anti-arrhythmic agents (Cifenline or Cibenzoline), Anticholinergics (Motion sickness patch (scopolamine), Bladder spasmolytic drugs (Propiverine), Chloroquine, Phenothiazines (Compazine, Mellaril, or Thorazine), Tricyclic antidepressants (Elavil, Nortriptyline, or Tofranil)
- •Accommodative amplitude <5 D in either eye as measured by the Donder's push-up method.
- •Manifest or latent nystagmus.
- •Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with treatment.
- •Household member or sibling already enrolled in the BI-CITT.
- •Any eye care professional, ophthalmic technician, ophthalmology or optometry resident or optometry student.
结局指标
主要结局
Symptom score on the Convergence Insufficiency Symptom Survey
次要结局
- Positive fusional vergence at near
- Near point of convergence
研究者
研究点 (19)
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