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

Pennsylvania College of Optometry10 sites in 1 country72 target enrollmentMay 2003

ConditionsConvergence Insufficiency

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Convergence Insufficiency
Sponsor: Pennsylvania College of Optometry
Enrollment: 72
Locations: 10
Primary Endpoint: Symptom score on the Convergence Insufficiency Symptom Survey
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

August 2004

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pennsylvania College of Optometry

Eligibility Criteria

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.