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

Pennsylvania College of Optometry

Status and phase

Completed

Phase 3

Conditions

Convergence Insufficiency

Treatments

Procedure: Placebo reading glasses

Procedure: Base-in prism glasses for reading

Study type

Interventional

Funder types

Industry

Identifiers

NCT00347581

hms0304

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

9 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.