NCT00472407

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

May 9, 2007

Last Update Submit

August 13, 2018

Conditions

Convergence Insufficiency

Keywords

Normal

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 9 to 17 years
  • Enrolled in participating school
  • Parental permission, assent
  • Ability to complete testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 29534348BACKGROUND

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Marjean Kulp, OD, MS

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2007

First Posted

May 11, 2007

Study Start

October 1, 2004

Primary Completion

November 1, 2006

Study Completion

January 1, 2008

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)