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

Completed · Phase 3 · Has a placebo group

Conditions studied: Convergence Insufficiency

In brief

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

Key facts

Study ID

NCT00347581

Run by

Pennsylvania College of Optometry

People needed

72

Starts

2003-05-01

Expected to finish

2004-08-01

Last updated by the study team

2006-07-04

Who can join

Age: 9 and older, up to 18. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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