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

Primary Purpose

Convergence Insufficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Base-in prism glasses for reading
Placebo reading glasses
Sponsored by
Pennsylvania College of Optometry
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convergence Insufficiency focused on measuring convergence insufficiency, base-in prism, orthoptics, vision therapy

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama, Birmingham, College of Optometry
  • Southern California College of Optometry
  • NOVA College of Optometry
  • Bascom Palmer Eye Institute
  • Indiana University College of Optometry
  • State University of New York, College of Optometry
  • The Ohio State University, Optometry Coordinating Center
  • The Ohio State University
  • Eye Institute, Pennsylvania College of Optometry
  • University of Houston, College of Optometry

Outcomes

Primary Outcome Measures

Symptom score on the Convergence Insufficiency Symptom Survey

Secondary Outcome Measures

Near point of convergence
Positive fusional vergence at near

Full Information

First Posted
July 3, 2006
Last Updated
July 3, 2006
Sponsor
Pennsylvania College of Optometry
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1. Study Identification

Unique Protocol Identification Number
NCT00347581
Brief Title
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
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 Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pennsylvania College of Optometry

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convergence Insufficiency
Keywords
convergence insufficiency, base-in prism, orthoptics, vision therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Base-in prism glasses for reading
Intervention Type
Procedure
Intervention Name(s)
Placebo reading glasses
Primary Outcome Measure Information:
Title
Symptom score on the Convergence Insufficiency Symptom Survey
Secondary Outcome Measure Information:
Title
Near point of convergence
Title
Positive fusional vergence at near

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Scheiman, OD
Organizational Affiliation
Pennsylvania College of Optometry
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama, Birmingham, College of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
NOVA College of Optometry
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University College of Optometry
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
State University of New York, College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
The Ohio State University, Optometry Coordinating Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Eye Institute, Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Houston, College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16170124
Citation
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.
Results Reference
result
PubMed Identifier
33263359
Citation
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.
Results Reference
derived
Links:
URL
http://optometry.osu.edu/research/CITT/
Description
Study Website

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

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