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Eye Movements and Reading Disabilities (EOMRD)

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ClinicalTrials.gov Identifier: NCT01860027
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 22, 2013
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Scripps Health

May 20, 2013
May 22, 2013
May 20, 2015
December 2013
September 2014   (Final data collection date for primary outcome measure)
Sensitivity and specificity of clinical eye movement devices [ Time Frame: 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).
Same as current
Complete list of historical versions of study NCT01860027 on ClinicalTrials.gov Archive Site
Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects. [ Time Frame: June 2014 ]

The secondary analysis will be a study group comparison of eye movement results for each reading variable using an analysis of covariance (ANCOVA) model. The 6 calculated reading variables are listed below and will be individually compared amongst the three groups.

i. Fixations / 100 words ii. Regressions / 100 words iii. Average span of recognition iv. Average duration of fixation v. Reading rate with comprehension vi. Grade level Efficiency

Same as current
Not Provided
Not Provided
 
Eye Movements and Reading Disabilities
Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Children with reading disorders, eye movement disorders or control (normal reading and eyemovements)between the ages of 7 and 13 are eligible for the study.
  • Reading Disability
  • Dyslexia
Not Provided
  • Children with reading disabilities
    Children diagnosed with reading disabilities (age 7 to 13).
  • Children with eye movement disorders
    Children diagnosed with eye movement disorders (age 7 to 13).
  • Control Group
    Children with normal reading ability and normal eye movements (age 7 to 13.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
120
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. Age 7 to 13 (Must be in at least 2nd grade, but not higher than 8th grade) 2. Complete ophthalmic examination performed by a pediatric ophthalmologist and orthoptist.

    3. All ocular structures must be within normal limits. 4. Best corrected visual acuity must be equal to or better than 20/30 in each eye.

    5. Group 1:

    1. Children with a reading disability must be given the diagnosis by a clinical educational specialist, educational psychologist or neuro-behavioral psychologist.
    2. 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.

      6. Group 2

    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).

    7. Group 3:

    1. No evidence of reading disability, attention deficit disorder or ocular anomaly, including eye muscle or movement disorder as specified above.

      Exclusion Criteria:

  • 1. Myopia more than - 6.00 diopters (spherical equivalent) in either eye. 2. Hyperopia more than + 6.00 diopters (spherical equivalent) in either eye. 3. History of vision therapy or orthoptic treatment 4. Any ocular anomaly with the exception of eye movement disorder for group 2.
Sexes Eligible for Study: All
7 Years to 13 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01860027
EOMRD
Yes
Not Provided
Not Provided
Scripps Health
Scripps Health
Not Provided
Principal Investigator: Gregory Ostrow, MD Scripps Clinic
Study Director: Laura Kirkeby, Orthoptics Scripps Clinic
Scripps Health
December 2013