Randomized Trial of Treatments for Convergence Insufficiency
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|ClinicalTrials.gov Identifier: NCT00347945|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
|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|
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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Estimated Study Completion Date :||November 2001|
- The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey
- Near Point of Convergence
- Positive Fusional Vergence at Near
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347945
|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|
|Study Chair:||Mitchell Scheiman, OD||Pennsylvania College of Optometry|