A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children

Convergence Insufficiency Clinical Trial

Official title:

A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347581
• Other study ID #: hms0304
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2006
• Last updated: July 3, 2006
• Start date: May 2003
• Est. completion date: August 2004

Study information

• Verified date: January 2005
• Source: Pennsylvania College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

The Base-in for Convergence Insufficiency Treatment Trial (BI-CITT) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (CI).

The goals of this clinical trial are:

• To compare the effectiveness of Base-in prism and Placebo eyeglasses for the treatment of CI in children

• To study the long-term effect of these treatments for CI

• To identify factors that may be associated with successful treatment of CI with base-in prism

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Procedure:
• Base-in prism glasses for reading

• Placebo reading glasses

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham, College of Optometry	Birmingham	Alabama
United States	Indiana University College of Optometry	Bloomington	Indiana
United States	The Ohio State University	Columbus	Ohio
United States	The Ohio State University, Optometry Coordinating Center	Columbus	Ohio
United States	NOVA College of Optometry	Ft. Lauderdale	Florida
United States	Southern California College of Optometry	Fullerton	California
United States	University of Houston, College of Optometry	Houston	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	State University of New York, College of Optometry	New York	New York
United States	Eye Institute, Pennsylvania College of Optometry	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pennsylvania College of Optometry

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom score on the Convergence Insufficiency Symptom Survey
Secondary	Near point of convergence
Secondary	Positive fusional vergence at near

External Links

•   Study Website