ADHDNCT00472511
Study of Eyes and Attention Deficit (SEAD)
An observational study of ADHD and Convergence Insufficiency, run by Ohio State University.
Trial summary
Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Convergence Insufficiency, Accommodative Insufficiency
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Best corrected visual acuity of 20/25 in both eyes at distance and near;
- Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary;
- 500" random dot stereopsis
Who cannot join
- Amblyopia (lazy eye);
- Eye disease
About this study
Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. However, the effect of ADHD medications on focusing and eye teaming has not been previously investigated. Therefore, the purpose of this study is to determine the effect of ADHD medication on focusing and eye teaming skills.
- Conditions
- ADHD, Convergence Insufficiency, Accommodative Insufficiency
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Ocular Motility Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Investigators
- Levelle Jenkins, OD, Principal investigator, Ohio State UniversityMarjean Kulp, OD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472511
- Sponsor's protocol ID
- 2001H0269
- Status last verified
- Jul 2008
- First submitted
- 9 May 2007
- Last updated
- 3 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Eyes and Attention Deficit (SEAD)
- ClinicalTrials.gov ID
- NCT00472511
- Acronym / sponsor ID
- 2001H0269
- Conditions
- ADHD, Convergence Insufficiency, Accommodative Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- First posted
- 11 May 2007 (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.
Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. However, the effect of ADHD medications on focusing and eye teaming has not been previously investigated. Therefore, the purpose of this study is to determine the effect of ADHD medication on focusing and eye teaming skills.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Best corrected visual acuity of 20/25 in both eyes at distance and near;
- Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary;
- 500" random dot stereopsis
Key exclusion criteria (2 listed)
- Amblyopia (lazy eye);
- Eye disease
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2008.
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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.
Levelle Jenkins, OD principal investigator
Ohio State University
Marjean Kulp, OD, MS principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Convergence Insufficiency, run by Ohio State University.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Jul 2008.