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

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ClinicalTrials.gov Identifier: NCT00347581

Recruitment Status : Completed

First Posted : July 4, 2006

Last Update Posted : July 4, 2006

Sponsor:

Information provided by:

Pennsylvania College of Optometry

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Convergence Insufficiency	Procedure: Base-in prism glasses for reading Procedure: Placebo reading glasses	Phase 3

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

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double
Primary Purpose:	Treatment
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
Study Start Date :	May 2003
Study Completion Date :	August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Genetic and Rare Diseases Information Center resources: Ocular Motility Disorders Motor Neuro-ophthalmic Disorders

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Symptom score on the Convergence Insufficiency Symptom Survey

Secondary Outcome Measures :

Near point of convergence
Positive fusional vergence at near

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	9 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347581

Locations


United States, Alabama
University of Alabama, Birmingham, College of Optometry
Birmingham, Alabama, United States, 35294
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
United States, Florida
NOVA College of Optometry
Ft. Lauderdale, Florida, United States, 33328
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Indiana
Indiana University College of Optometry
Bloomington, Indiana, United States, 47405
United States, New York
State University of New York, College of Optometry
New York, New York, United States, 10036
United States, Ohio
The Ohio State University, Optometry Coordinating Center
Columbus, Ohio, United States, 43210
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Eye Institute, Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
University of Houston, College of Optometry
Houston, Texas, United States, 77204

Sponsors and Collaborators

Pennsylvania College of Optometry

Investigators


Study Chair:	Mitchell Scheiman, OD	Pennsylvania College of Optometry

More Information

Additional Information:

Study Website This link exits the ClinicalTrials.gov site

Publications of Results:

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.


ClinicalTrials.gov Identifier:	NCT00347581 History of Changes
Other Study ID Numbers:	hms0304
First Posted:	July 4, 2006 Key Record Dates
Last Update Posted:	July 4, 2006
Last Verified:	January 2005

Keywords provided by Pennsylvania College of Optometry:


convergence insufficiency base-in prism orthoptics vision therapy

Additional relevant MeSH terms:


Ocular Motility Disorders Central Nervous System Diseases Nervous System Diseases Cranial Nerve Diseases Eye Diseases Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics Autonomic Agents	Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors

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