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

July 3, 2006 updated by: Pennsylvania College of Optometry

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.

Study Overview

Status

Completed

Conditions

Convergence Insufficiency

Intervention / Treatment

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 Type

Interventional

Enrollment

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptom score on the Convergence Insufficiency Symptom Survey

Secondary Outcome Measures

Outcome Measure
Near point of convergence
Positive fusional vergence at near

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennsylvania College of Optometry

Investigators

Study Chair: Mitchell Scheiman, OD, Pennsylvania College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study Website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

July 3, 2006

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

hms0304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.