About the Convergence Insufficiency Treatment Trial (CITT)
This study is comparing treatments for an eye-teaming problem called convergence insufficiency in children ages 9 to 17 years of age. Approximately 208 subjects will be entered into the study and assigned to one of four treatment groups. Two treatments are done at home. They are Pencil Push-up treatment and Pencil Push-ups with Computer Vision Therapy. The other two treatments are done in the office and include home exercises. They are Vision Therapy and Placebo (like a sugar pill) Vision Therapy. There have been no really good research studies showing that any of these treatments work well or if one is better than the other. In fact, some people think that just visiting your doctor's office regularly can make patients feel better and improve how their eyes feel. The placebo treatment group is included to look into this. Eye doctors are not sure which treatment is better.
Each study participant will receive treatment for 12 weeks. Then there will be a follow-up visit at 6 months and 1 year. If the study participant is not better after the 12-week treatment program, another doctor at the clinic will be able to prescribe a different treatment. There will be no cost for this but it must be started within 1 month of the 12-week visit. Depending on the treatment given, up to 12 more weeks of treatment might be necessary.
All visits for the study and any required vision therapy equipment are free of charge. In addition, to cover time and travel costs, children who come into the office for treatment will be given $20 for each therapy visit attended. The children in the two home based groups will receive $20 for each scheduled phone call that is completed. Therefore, the compensation is the same in all 4 treatment groups. In addition, participants will be given $50 per visit for the 3 follow-up exams. This includes the exam after 12 weeks of treatment have been completed and the 6-month and 12-month exams.
The study is being conducted at nine clinic sites across the US. Locations can be found in Alabama, California, Florida, Minnesota, New York, Pennsylvania and Ohio.
For more information on the study, please use the "contact us" feature from the toolbar above.