Randomized Trial of Treatments for Convergence Insufficiency - Full Text View

Sponsors and Collaborators:	Pennsylvania College of Optometry National Eye Institute (NEI)
Information provided by:	Pennsylvania College of Optometry
ClinicalTrials.gov Identifier:	NCT00347945

Purpose

The Convergence Insufficiency Treatment Trial (CITT) is a multi-center, placebo-controlled, single-masked, clinical trial designed to compare the benefits of two commonly used treatment approaches for patients with convergence insufficiency (CI)

Condition	Intervention	Phase
Convergence Insufficiency	Procedure: Pencil Push-ups Procedure: Office-based Vision Therapy Procedure: Placebo Office-based Vision Therapy	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency

Further study details as provided by Pennsylvania College of Optometry:

Primary Outcome Measures:

The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey

Secondary Outcome Measures:

Near Point of Convergence
Positive Fusional Vergence at Near

Estimated Enrollment:	90
Study Start Date:	October 2000
Estimated Study Completion Date:	November 2001

Detailed Description:

Considerable controversy exists regarding the best treatment for convergence insufficiency (CI), a common condition that often interferes with the ability to perform near work. The two most widely used treatments have significant differences in costs and in practitioner perceived utility. Pencil push-up therapy (PPT) is a simple, low-cost treatment in which patients are prescribed a single procedure to perform at home with only periodic follow-up. Office-based vision therapy (OBVT) is a more comprehensive, time-consuming, complex, and costly treatment in which patients are scheduled for weekly in-office therapy visits and are often prescribed a specific sequence of therapeutic procedures to perform at home. It is important to consider whether either, neither, or both treatments are effective.

The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked-examiner, multi-center clinical trial in which patients are randomized to one of these two treatment approaches. The primary goal is to answer the following question:

After 12 weeks of treatment, is one therapy more effective than the other in improving CI signs and symptoms? We will test the null hypothesis that there is no difference in the distribution of outcomes between the two populations.

The primary outcome measure will be a classification of each patient as a “success,” “improvement,” or “failure.” This classification will be based on the level of improvement in both the signs (near point of convergence and positive fusional vergence) and symptoms of CI.

Additional questions relate to longer term effects:

Are the patients who were classified as “success” or “improvement” at twelve weeks the same at the one-year follow-up for each treatment group?
Are there differences in the distributions of changes in near point of convergence, positive fusional vergence, or accommodative amplitudes, between the two treatment groups, at twelve weeks and at one-year of follow up?

Eligibility

Ages Eligible for Study:	9 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 9-30 years
Best corrected visual acuity of 20/25 in both eyes at distance and near
Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary
Exophoria at near at least 4 prism diopters greater than at far
Insufficient positive fusional convergence (i.e., failing Sheard’s criterion or minimum normative positive fusional vergence (PFV) of 15 base-out break).
Receded near point of convergence of > 6 cm break.
Normal random dot stereopsis using a 500 seconds of arc target.
CI Symptom Survey score > 16 for subjects in 9-18 year age range and > 21 for subjects in the 19-30 year age range.
Informed consent and willingness to participate in the study and be randomized

Exclusion Criteria:

CI previously treated with pencil push-ups (no more than 2 months of treatment within the past year)
CI previously treated with office-based vision therapy/orthoptics (no more than 2 months of treatment within the past year)
Amblyopia
Constant strabismus
History of strabismus surgery
Anisometropia >1.50D difference between eyes
Prior refractive surgery
Vertical heterophoria greater than 1 
Systemic diseases known to affect accommodation, vergence, and ocular motility such as: multiple sclerosis, Graves’s thyroid disease, myasthenia gravis, diabetes, and Parkinson disease
Any ocular or systemic medication known to affect accommodation or vergence
Monocular accommodative amplitude less than 4 D in either eye as measured by the Donder’s push-up method
Manifest or latent nystagmus
Attention deficit hyperactivity disorder (ADHD) or learning disability diagnosis by parental report
Household member or sibling already enrolled in the CITT
Any eye care professional, technician, medical student, or optometry student

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347945

Locations

United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
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, Oregon
Pacific University College of Optometry
Forest Grove, Oregon, United States, 97116
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

National Eye Institute (NEI)

Investigators

Study Chair:

Mitchell Scheiman, OD

Pennsylvania College of Optometry

More Information

Study Website This link exits the ClinicalTrials.gov site

Publications of Results:

Scheiman M, Mitchell GL, Cotter S, Cooper J, Kulp M, Rouse M, Borsting E, London R, Wensveen J; Convergence Insufficiency Treatment Trial Study Group. A randomized clinical trial of treatments for convergence insufficiency in children. Arch Ophthalmol. 2005 Jan;123(1):14-24.

Scheiman M, Mitchell GL, Cotter S, Kulp MT, Cooper J, Rouse M, Borsting E, London R, Wensveen J. A randomized clinical trial of vision therapy/orthoptics versus pencil pushups for the treatment of convergence insufficiency in young adults. Optom Vis Sci. 2005 Jul;82(7):583-95.

Other Publications:

Borsting EJ, Rouse MW, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in children aged 9 to 18 years. Optom Vis Sci. 2003 Dec;80(12):832-8.

Gallaway M, Scheiman M, Malhotra K. The effectiveness of pencil pushups treatment for convergence insufficiency: a pilot study. Optom Vis Sci. 2002 Apr;79(4):265-7.

Scheiman M, Cooper J, Mitchell GL, de LP, Cotter S, Borsting E, London R, Rouse M. A survey of treatment modalities for convergence insufficiency. Optom Vis Sci. 2002 Mar;79(3):151-7.

Study ID Numbers:	HMS2040, 1R21EY13164-1
Study First Received:	July 3, 2006
Last Updated:	July 3, 2006
ClinicalTrials.gov Identifier:	NCT00347945
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennsylvania College of Optometry:

convergence insufficiency, vision therapy, orthoptics

Study placed in the following topic categories:

Ocular Motility Disorders
Motor neuro-ophthalmic disorders
Eye Diseases
Central Nervous System Diseases
Ocular motility disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on January 14, 2009