Convergence InsufficiencyNCT00472407
Screening for Convergence Insufficiency in School-age Children
An observational study of Convergence Insufficiency, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jan 2008
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Of the 282 subjects included in the analysis, approximately 60% were female, 81.5% identified themselves as white, 11% as African American, 2.5% as other, and 5% did not report race. Two percent classified themselves as Hispanic or Latino, 76% reported not being Hispanic or Latino, and 22% did not report their ethnicity.
Who may be able to join
- Age 9 to 17 years
- Enrolled in participating school
- Parental permission, assent
- Ability to complete testing
- Exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Official title: Screening Eye Coordination Study Screening for Convergence Insufficiency in School-age Children
The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.
Read the detailed description
The purpose of the Screening for Convergence Insufficiency in School-age Children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).
- Conditions
- Convergence Insufficiency
- Keywords
- Normal
- Medical subject headings
- 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)
- Study startOct 2004
- Primary completionNov 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Convergence InsufficiencyStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjean Kulp, Ohio State University
- Investigators
- Marjean Kulp, OD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472407
- Sponsor's protocol ID
- 2004H0161
- Status last verified
- Aug 2018
- First submitted
- 9 May 2007
- Last updated
- 15 Aug 2018
- Results posted
- No
Publications
Menjivar AM, Kulp MT, Mitchell GL, Toole AJ, Reuter K. Screening for convergence insufficiency in school-age children. Clin Exp Optom. 2018 Jul;101(4):578-584. doi: 10.1111/cxo.12661. Epub 2018 Mar 13.
PubMed 29534348
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Eye Coordination Study Screening for Convergence Insufficiency in School-age Children
- ClinicalTrials.gov ID
- NCT00472407
- Acronym / sponsor ID
- 2004H0161
- Conditions
- Convergence Insufficiency
- Keywords
- Normal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Oct 2004 (actual)
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2008 (actual)
- 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.
The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.
Detailed description
The purpose of the Screening for Convergence Insufficiency in School-age Children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Of the 282 subjects included in the analysis, approximately 60% were female, 81.5% identified themselves as white, 11% as African American, 2.5% as other, and 5% did not report race. Two percent classified themselves as Hispanic or Latino, 76% reported not being Hispanic or Latino, and 22% did not report their ethnicity.
Key inclusion criteria (5 listed)
- Age 9 to 17 years
- Enrolled in participating school
- Parental permission, assent
- Ability to complete testing
- Exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error
Key exclusion criteria (0 listed)
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 15 Aug 2018.
- Background: PubMed 29534348Menjivar AM, Kulp MT, Mitchell GL, Toole AJ, Reuter K. Screening for convergence insufficiency in school-age children. Clin Exp Optom. 2018 Jul;101(4):578-584. doi: 10.1111/cxo.12661. Epub 2018 Mar 13.
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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.
Marjean Kulp, OD, MS principal investigator
Ohio State University
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 Convergence Insufficiency, run by Ohio State University 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 5 inclusion and 0 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 15 Aug 2018. 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 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?
On the ClinicalTrials.gov record for NCT00472407, which also lists 1 linked publication.
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 15 Aug 2018.