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

This study has been completed.
Sponsor:
Information provided by:
Pennsylvania College of Optometry
ClinicalTrials.gov Identifier:
NCT00347581
First received: July 3, 2006
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pennsylvania College of Optometry:

Primary Outcome Measures:
  • Symptom score on the Convergence Insufficiency Symptom Survey

Secondary Outcome Measures:
  • Near point of convergence
  • Positive fusional vergence at near

Estimated Enrollment: 72
Study Start Date: May 2003
Estimated Study Completion Date: August 2004
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
  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Columbus, Ohio, United States, 43210
The Ohio State University, Optometry Coordinating Center
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:
Publications:
ClinicalTrials.gov Identifier: NCT00347581     History of Changes
Other Study ID Numbers: hms0304
Study First Received: July 3, 2006
Last Updated: July 3, 2006
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014