Clinical Trial: Convergence Insufficiency Treatment Trial (CITT)
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Convergence Insufficiency Treatment Trial (CITT)
Brief Summary:
The purposes of the CITT are:
- To determine whether Home-based Pencil Push-up therapy, Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics or Office-based VT/Orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs.
- To evaluate whether improvements in outcome measures are still present after one year of observation.
Detailed Summary:
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.
Sponsor: National Eye Institute (NEI)
Current Primary Outcome: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey [ Time Frame: 12 weeks ]
Original Primary Outcome: Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey
Current Secondary Outcome: Eyes' ability to converge when performing close work [ Time Frame: 12 weeks ]
Original Secondary Outcome: Eyes' ability to converge when performing close work
Information By: National Eye Institute (NEI)
Dates:
Date Received: June 15, 2006
Date Started: July 2005
Date Completion: September 2009
Last Updated: March 24, 2010
Last Verified: October 2008
