Status:
COMPLETED
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
Lead Sponsor:
Pennsylvania College of Optometry
Conditions:
Convergence Insufficiency
Eligibility:
All Genders
9-18 years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00347581
Start Date
May 1 2003
End Date
August 1 2004
Last Update
July 4 2006
Active Locations (10)
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1
University of Alabama, Birmingham, College of Optometry
Birmingham, Alabama, United States, 35294
2
Southern California College of Optometry
Fullerton, California, United States, 92831
3
NOVA College of Optometry
Fort Lauderdale, Florida, United States, 33328
4
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136