A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
- Conditions
- Convergence Insufficiency
- Registration Number
- NCT00347581
- Lead Sponsor
- Pennsylvania College of Optometry
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Symptom score on the Convergence Insufficiency Symptom Survey
- Secondary Outcome Measures
Name Time Method Positive fusional vergence at near Near point of convergence
Trial Locations
- Locations (10)
University of Alabama, Birmingham, College of Optometry
🇺🇸Birmingham, Alabama, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Southern California College of Optometry
🇺🇸Fullerton, California, United States
NOVA College of Optometry
🇺🇸Ft. Lauderdale, Florida, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Indiana University College of Optometry
🇺🇸Bloomington, Indiana, United States
The Ohio State University, Optometry Coordinating Center
🇺🇸Columbus, Ohio, United States
State University of New York, College of Optometry
🇺🇸New York, New York, United States
Eye Institute, Pennsylvania College of Optometry
🇺🇸Philadelphia, Pennsylvania, United States
University of Houston, College of Optometry
🇺🇸Houston, Texas, United States