Convergence Insufficiency Clinical Trial
Official title:
A Randomized Clinical Trial of the Effectiveness of Base-in Prism Reading Glasses Vs. Placebo Reading Glasses for Symptomatic Convergence Insufficiency in Children
This study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Years to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama, Birmingham, College of Optometry | Birmingham | Alabama |
United States | Indiana University College of Optometry | Bloomington | Indiana |
United States | The Ohio State University | Columbus | Ohio |
United States | The Ohio State University, Optometry Coordinating Center | Columbus | Ohio |
United States | NOVA College of Optometry | Ft. Lauderdale | Florida |
United States | Southern California College of Optometry | Fullerton | California |
United States | University of Houston, College of Optometry | Houston | Texas |
United States | Bascom Palmer Eye Institute | Miami | Florida |
United States | State University of New York, College of Optometry | New York | New York |
United States | Eye Institute, Pennsylvania College of Optometry | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Pennsylvania College of Optometry |
United States,
Scheiman M, Cotter S, Rouse M, Mitchell GL, Kulp M, Cooper J, Borsting E; Convergence Insufficiency Treatment Trial Study Group. Randomised clinical trial of the effectiveness of base-in prism reading glasses versus placebo reading glasses for symptomatic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom score on the Convergence Insufficiency Symptom Survey | |||
Secondary | Near point of convergence | |||
Secondary | Positive fusional vergence at near |
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