NCT00347581

Brief Summary

This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

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

May 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

January 1, 2005

First QC Date

July 3, 2006

Last Update Submit

July 3, 2006

Conditions

Convergence Insufficiency

Keywords

convergence insufficiencybase-in prismorthopticsvision therapy

Outcome Measures

Primary Outcomes (1)

  • Symptom score on the Convergence Insufficiency Symptom Survey

Secondary Outcomes (2)

  • Near point of convergence

  • Positive fusional vergence at near

Interventions

Base-in prism glasses for readingPROCEDURE
Placebo reading glassesPROCEDURE

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 9 to \<19 years.
  • Best corrected visual acuity of ≥20/25 in each eye at distance and near
  • Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
  • Willingness to wear glasses for reading and other near work
  • Exophoria at near at least 4 greater than at far
  • Insufficient positive fusional convergence (fails Sheard's criterion)
  • Receded near point of convergence of  6 cm break
  • Random dot stereopsis appreciation using a 500 seconds of arc target.
  • CI Symptom Survey score  16

You may not qualify if:

  • Amblyopia (\> 2 line difference in best corrected visual acuity between the two eyes).
  • Constant strabismus
  • History of strabismus surgery.
  • Anisometropia  2D in any meridian between the eyes.
  • Prior refractive surgery.
  • Vertical heterophoria greater than 1 .
  • Systemic diseases known to affect accommodation, vergence and ocular motility such as: multiple sclerosis, Graves thyroid disease, myasthenia gravis, diabetes, Parkinson disease.
  • Any ocular or systemic medication known to affect accommodation or vergence (Anti-anxiety agents (Librium or Valium), Anti-arrhythmic agents (Cifenline or Cibenzoline), Anticholinergics (Motion sickness patch (scopolamine), Bladder spasmolytic drugs (Propiverine), Chloroquine, Phenothiazines (Compazine, Mellaril, or Thorazine), Tricyclic antidepressants (Elavil, Nortriptyline, or Tofranil)
  • Accommodative amplitude \<5 D in either eye as measured by the Donder's push-up method.
  • Manifest or latent nystagmus.
  • Developmental disability, mental retardation, attention deficit hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with treatment.
  • Household member or sibling already enrolled in the BI-CITT.
  • Any eye care professional, ophthalmic technician, ophthalmology or optometry resident or optometry student.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama, Birmingham, College of Optometry

Birmingham, Alabama, 35294, United States

Location

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

NOVA College of Optometry

Fort Lauderdale, Florida, 33328, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Indiana University College of Optometry

Bloomington, Indiana, 47405, United States

Location

State University of New York, College of Optometry

New York, New York, 10036, United States

Location

The Ohio State University, Optometry Coordinating Center

Columbus, Ohio, 43210, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Eye Institute, Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

University of Houston, College of Optometry

Houston, Texas, 77204, United States

Location

Related Publications (2)

  • Scheiman M, Cotter S, Rouse M, Mitchell GL, Kulp M, Cooper J, Borsting E; Convergence Insufficiency Treatment Trial Study Group. Randomised clinical trial of the effectiveness of base-in prism reading glasses versus placebo reading glasses for symptomatic convergence insufficiency in children. Br J Ophthalmol. 2005 Oct;89(10):1318-23. doi: 10.1136/bjo.2005.068197.

    PMID: 16170124RESULT

  • Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.

    PMID: 33263359DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Mitchell Scheiman, OD

    Pennsylvania College of Optometry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

May 1, 2003

Study Completion

August 1, 2004

Last Updated

July 4, 2006

Record last verified: 2005-01

Locations

US(10)