Randomized Trial of Treatments for Convergence Insufficiency

Convergence Insufficiency Clinical Trial

Official title:

A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347945
• Other study ID #: HMS2040
• Secondary ID: 1R21EY13164-1
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2006
• Last updated: July 3, 2006
• Start date: October 2000
• Est. completion date: November 2001

Study information

• Verified date: January 2002
• Source: Pennsylvania College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Convergence Insufficiency
• Ocular Motility Disorders

Intervention

Procedure:
• Pencil Push-ups

• Office-based Vision Therapy

• Placebo Office-based Vision Therapy

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	The Ohio State University, Optometry Coordinating Center	Columbus	Ohio
United States	Pacific University College of Optometry	Forest Grove	Oregon
United States	Southern California College of Optometry	Fullerton	California
United States	University of Houston, College of Optometry	Houston	Texas
United States	State University of New York, College of Optometry	New York	New York
United States	Eye Institute, Pennsylvania College of Optometry	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pennsylvania College of Optometry	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. 20 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
Secondary	Near Point of Convergence
Secondary	Positive Fusional Vergence at Near

External Links

•   Study Website