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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00338611 |
Purpose
The purposes of the CITT are:
| Condition | Intervention | Phase |
|---|---|---|
|
Convergence Insufficiency Binocular Vision Disorder |
Behavioral: Home-based Pencil Push-Up Therapy Behavioral: Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics Behavioral: Office-based Vision Therapy/Orthoptics Behavioral: Placebo Office-based Vision Therapy/Orthoptics |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Convergence Insufficiency Treatment Trial (CITT) |
| Enrollment: | 221 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Convergence insufficiency is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life.
There is no consensus regarding the most effective treatment for convergence insufficiency. Two commonly prescribed treatments are home-based pencil push-up therapy and office-based vision therapy/orthoptics. Significant differences exist between these two treatment modalities in cost and number of office visits required, with pencil push-up therapy being less expensive and less time intensive. There have been no well-designed studies that have compared the effectiveness of these two treatments.
The Convergence Insufficiency Treatment Trial (CITT) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to < 18 years will be randomly assigned to: 1) Home-based Pencil Push-Up Therapy, 2) Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics, 3) Office-based Vision Therapy/Orthoptics, or 4) Placebo Office-based Vision Therapy/Orthoptics. The primary outcome measure is a measure of symptoms using a 15-item survey, the CI Symptom Survey. Secondary outcome measures are two common clinical tests of the eyes' ability to converge when performing close work. Patients will be tested at the eligibility examination, and by masked examiners after 4, 8 and 12 weeks of treatment have been completed during the 12-week treatment phase. Long term follow-up will be assessed at 6 and 12 months after the completion of active treatment.
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham School of Optometry | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Ratner Children's Eye Center | |
| La Jolla, California, United States, 92093 | |
| Southern California College of Optometry | |
| Fullerton, California, United States, 92093 | |
| United States, Florida | |
| NOVA Southeastern University College of Optometry | |
| Ft. Lauderdale, Florida, United States, 33328 | |
| Bascom Palmer Eye Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| 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 College of Optometry | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Pennsylvania College of Optometry | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Study Chair: | Mitchell Scheiman, OD | Pennsylvania College of Optometry |
More Information
| Responsible Party: | Pennsylvania College of Optometry ( Mitchell Scheiman, OD ) |
| Study ID Numbers: | NEI-107 |
| Study First Received: | June 15, 2006 |
| Last Updated: | October 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00338611 History of Changes |
| Health Authority: | United States: Federal Government |
|
vision therapy orthoptics pencil push-up therapy |
|
Signs and Symptoms Sensation Disorders Ocular Motility Disorders Vision Disorders Eye Diseases |
Nervous System Diseases Central Nervous System Diseases Neurologic Manifestations Cranial Nerve Diseases |