Eye Movements and Reading Disabilities (EOMRD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01860027
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 22, 2013
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Scripps Health

Brief Summary:

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.

Condition or disease
Reading Disability Dyslexia

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities
Study Start Date : December 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01860027

United States, California
Scripps Clinic
San Diego, California, United States, 92130
Sponsors and Collaborators
Scripps Health
Principal Investigator: Gregory Ostrow, MD Scripps Clinic
Study Director: Laura Kirkeby, Orthoptics Scripps Clinic

Responsible Party: Scripps Health Identifier: NCT01860027     History of Changes
Other Study ID Numbers: EOMRD
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: December 2013

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders