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临床试验/NCT03123822
NCT03123822终止不适用

To Compare the Effectiveness of 3 Different Types of Lens and Lens Coating in Eliminating Symptoms for Children With Prolonged Visual Symptoms Due to a Concussion.

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Convergence Insufficiency Symptom Survey

研究概览

简要总结

We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.

详细描述

Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Sustained a concussion > 6 weeks < 16 weeks from date of initial visit
  • Criteria for concussion: formally diagnosed by physician
  • Minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near
  • Minimum Stereopsis: 500" global
  • CISS score > 16
  • Refractive error at least + 0.50D sphere or cylinder
  • Ability to clear > 0.50 cycles per minute in monocular accommodative flipper of and binocular accommodative flipper of +/-1.50

排除标准

  • Diplopia from nerve palsies
  • Retinal pathology
  • Previous treatment of any amount of bifocal lenses and base in prism since concussion.
  • Vision therapy > 6 weeks since concussion

结局指标

主要结局

Convergence Insufficiency Symptom Survey

时间窗: Assessed up to 12 months

This survey quantifies convergence insufficiency symptoms on a scale. The scale measures the severity of symptoms from the condition, convergence insufficiency. Score on a scale can range from 0 (least) to 60 (worst). This survey has been proven to be an effective and accurate gauge by previous research and study groups.

次要结局

  • Convergence Breaking Point at Near (Base Out Prism)(Assessed up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine K Weise

Director of Pediatric Optometry Services

University of Alabama at Birmingham

研究点 (2)

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