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

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

Detailed Description
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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

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

Conditions
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Convergence Insufficiency

Intervention / Treatment
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* Procedure: Base-in prism glasses for reading
* Procedure: Placebo reading glasses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Base-in prism glasses for reading|nan|
|Procedure: Placebo reading glasses|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score on the Convergence Insufficiency Symptom Survey |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near point of convergence |  |  | 
| Positive fusional vergence at near |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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convergence insufficiency, base-in prism, orthoptics, vision therapy