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Sponsors and Collaborators: |
Pennsylvania College of Optometry National Eye Institute (NEI) |
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Information provided by: | Pennsylvania College of Optometry |
ClinicalTrials.gov Identifier: | NCT00347945 |
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 |
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Convergence Insufficiency |
Procedure: Pencil Push-ups Procedure: Office-based Vision Therapy Procedure: Placebo Office-based Vision Therapy |
Phase III |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | October 2000 |
Estimated Study Completion Date: | November 2001 |
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:
Ages Eligible for Study: | 9 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Mitchell Scheiman, OD | Pennsylvania College of Optometry |
Study ID Numbers: | HMS2040, 1R21EY13164-1 |
Study First Received: | July 3, 2006 |
Last Updated: | July 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00347945 History of Changes |
Health Authority: | United States: Institutional Review Board |
convergence insufficiency, vision therapy, orthoptics |
Ocular Motility Disorders Eye Diseases Central Nervous System Diseases Motor Neuro-ophthalmic Disorders |
Ocular Motility Disorders Eye Diseases Nervous System Diseases Central Nervous System Diseases Cranial Nerve Diseases |