Randomized Trial of Treatments for Convergence Insufficiency

• ClinicalTrials.gov Identifier: NCT00347945
• Recruitment Status: Completed
• First Posted: July 4, 2006
• Last Update Posted: July 4, 2006
• Sponsor: Pennsylvania College of Optometry
• Collaborator: National Eye Institute (NEI)
• Information provided by: Pennsylvania College of Optometry

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Convergence Insufficiency	Procedure: Pencil Push-ups; Procedure: Office-based Vision Therapy; Procedure: Placebo Office-based Vision Therapy	Phase 3

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:

1. 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?
2. 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?

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
• Study Start Date: October 2000
• Study Completion Date: November 2001

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Near Point of Convergence
2. Positive Fusional Vergence at Near

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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, Optometry Coordinating Center

Columbus, Ohio, United States, 43210

The Ohio State University

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

Additional Information:

Study Website 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD006768. doi: 10.1002/14651858.CD006768.pub3.

• ClinicalTrials.gov Identifier: NCT00347945
• Other Study ID Numbers: HMS2040; 1R21EY13164-1
• First Posted: July 4, 2006
• Last Update Posted: July 4, 2006
• Last Verified: January 2002

Keywords provided by Pennsylvania College of Optometry:

convergence insufficiency, vision therapy, orthoptics

Additional relevant MeSH terms:

Ocular Motility Disorders; Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases