Clinical Trial: Randomized Trial of Treatments for Convergence Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Clinical Trial of Pencil Push-Ups Versus Office Based Vision Therapy For the Treatment of Convergence Insufficiency
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)
Detailed Summary:
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 clas
Sponsor: Pennsylvania College of Optometry
Current Primary Outcome: The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Near Point of Convergence
- Positive Fusional Vergence at Near
Original Secondary Outcome: Same as current
Information By: Pennsylvania College of Optometry
Dates:
Date Received: July 3, 2006
Date Started: October 2000
Date Completion: November 2001
Last Updated: July 3, 2006
Last Verified: January 2002
