跳至主要内容
临床试验/NCT01860027
NCT01860027终止不适用

Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities

Scripps Health1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Sensitivity and specificity of clinical eye movement devices

研究概览

简要总结

The mechanism of the eye movement anomalies seen in dyslexic patients is not well defined. Some optometrists use observational eye movement tests as screening devices for dyslexia and advocate eye movement therapy as a treatment option for dyslexia. The reliability of the clinical eye movement tests and the efficacy of the eye movement therapies have not been determined.

Saccades are the fast eye movements that move our eyes from one word to the next when we read. The eye movement recordings from patients diagnosed with reading disorders, extra ocular muscle imbalances and control patients (no learning disability or eye movement disorder) will be analyzed and compared. The sensitivity and specificity of detecting reading disorders will be determined for the Visagraph III and the Readalyzer. Although these clinical tests are frequently used to diagnose saccadic inaccuracies and diagnose dyslexia in school aged children, the validity of these clinical screening tests has not been determined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 7 to 13 (Must be in at least 2nd grade, but not higher than 8th grade)
  • Complete ophthalmic examination performed by a pediatric ophthalmologist and orthoptist.
  • All ocular structures must be within normal limits.
  • Best corrected visual acuity must be equal to or better than 20/30 in each eye.
  • Children with a reading disability must be given the diagnosis by a clinical educational specialist, educational psychologist or neuro-behavioral psychologist.
  • Children with a reading disability may not have any ophthalmic anomaly determined by testing as described above. This includes but is not limited to amblyopia, strabismus, nystagmus, or any organic disease.
  • a. Eye movement disorder confirmed by testing by a pediatric ophthalmologist and/or orthoptist b. All other ocular structures must be within normal limits (including visual acuity).
  • No evidence of reading disability, attention deficit disorder or ocular anomaly, including eye muscle or movement disorder as specified above.

排除标准

  • Myopia more than - 6.00 diopters (spherical equivalent) in either eye.
  • Hyperopia more than + 6.00 diopters (spherical equivalent) in either eye.
  • History of vision therapy or orthoptic treatment
  • Any ocular anomaly with the exception of eye movement disorder for group 2.

结局指标

主要结局

Sensitivity and specificity of clinical eye movement devices

时间窗: June 2014

The primary analysis will be determining the sensitivity and specificity of the eye movement recording devices to recognize reading disorders. The sensitivity (true positive rate) of the eye movement recorders will be determined by the ability of each device to recognize children with reading disorders in Group 1. The specificity of the recorders will be determined by calculating the false positives in group 2 (eye movement disorders), and group 3 (control subjects).

次要结局

  • Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects.(June 2014)

研究者

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

Shelly Meese

Project Manager

Scripps Health

研究点 (1)

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