Eye Movements and Reading Disabilities (EOMRD)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Scripps Health
Sponsor:
Information provided by (Responsible Party):
Scripps Health
ClinicalTrials.gov Identifier:
NCT01860027
First received: May 20, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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
Reading Disability
Dyslexia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities

Resource links provided by NLM:


Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • Sensitivity and specificity of clinical eye movement devices [ Time Frame: June 2014 ] [ Designated as safety issue: No ]
    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:
  • Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects. [ Time Frame: June 2014 ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860027

Contacts
Contact: Laura L Kirkeby, Orthoptics 8587643176 kirkeby.laura@scrippshealth.org

Locations
United States, California
Scripps Clinic Not yet recruiting
San Diego, California, United States, 92130
Contact: Laura Kirkeby    858-764-3176      
Principal Investigator: Gregory I Ostrow, MD         
Sponsors and Collaborators
Scripps Health
Investigators
Principal Investigator: Gregory Ostrow, MD Scripps Clinic
Study Director: Laura Kirkeby, Orthoptics Scripps Clinic
  More Information

No publications provided

Responsible Party: Scripps Health
ClinicalTrials.gov Identifier: NCT01860027     History of Changes
Other Study ID Numbers: EOMRD
Study First Received: May 20, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014