Clinical trial NCT01860027: Eye Movements and Reading Disabilities
Official title: Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Reading Disability
Dyslexia
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 1
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Sensitivity and specificity of clinical eye movement devices
timeFrame: June 2014
Secondary outcomes:
measure: Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects.
timeFrame: June 2014
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic
state: California
Study officials:
affiliation: Scripps Clinic
name: Gregory Ostrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Clinic
name: Laura Kirkeby, Orthoptics
role: STUDY_DIRECTOR
References: