A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
NCT ID: NCT00347581
Last Updated: 2006-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2003-05-31
2004-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Base-in prism glasses for reading
Placebo reading glasses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
9 Years
18 Years
ALL
Yes
Sponsors
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Pennsylvania College of Optometry
INDUSTRY
Principal Investigators
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Mitchell Scheiman, OD
Role: STUDY_CHAIR
Pennsylvania College of Optometry
Locations
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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
Countries
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References
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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 convergence insufficiency in children. Br J Ophthalmol. 2005 Oct;89(10):1318-23. doi: 10.1136/bjo.2005.068197.
Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
Other Identifiers
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hms0304
Identifier Type: -
Identifier Source: org_study_id