Reading DisabilityEOMRDNCT01860027
Eye Movements and Reading Disabilities
An observational study of Reading Disability and Dyslexia, run by Scripps Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Disability, Dyslexia
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 1 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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:
- 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.
- 6. Group 2
Show all 9Show fewer
- 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:
- No evidence of reading disability, attention deficit disorder or ocular anomaly, including eye muscle or movement disorder as specified above.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Reading Disability, Dyslexia
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of clinical eye movement devices
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).
Measured: June 2014
Secondary outcomes (1)
Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects.
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.
- 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
Measured: June 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startDec 2013
- Primary completion1 Sep 2014
- Study completion1 Sep 2014
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Meese, Scripps Health
- Investigators
- Gregory Ostrow, MD, Principal investigator, Scripps ClinicLaura Kirkeby, Orthoptics, Study director, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860027
- Sponsor's protocol ID
- EOMRD
- Acronym
- EOMRD
- Status last verified
- Nov 2023
- First submitted
- 20 May 2013
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Clinical Eye Movement Tests as Screening Devices for Reading Disabilities
- ClinicalTrials.gov ID
- NCT01860027
- Acronym / sponsor ID
- EOMRD / EOMRD
- Conditions
- Reading Disability, Dyslexia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (9 listed)
- 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.
- 6. Group 2
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Comparison of eye movement characteristics amongst patients with reading disorders, eye movement abnormalities and control subjects.
Time frame: June 2014
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Ostrow, MD principal investigator
Scripps Clinic
Laura Kirkeby, Orthoptics study director
Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reading Disability and Dyslexia, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of clinical eye movement devices (time frame: June 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.