Convergence Insufficiency Treatment Trial (CITT)

• Measure of symptoms using a 15-item Convergence Insufficiency Symptom Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  

• Eyes' ability to converge when performing close work [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  

Behavioral: Home-based Pencil Push-Up Therapy
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose
Behavioral: Home-based Pencil Push-ups with Computer Vision Therapy/Orthoptics
Exercise in which patients visually followed a small letter on a pencil as they moved the pencil closer to the bridge of their nose combined with additional computer vision therapy
Behavioral: Office-based Vision Therapy/Orthoptics
Weekly hour-long sessions of office-based vision therapy with a trained therapist and performed at-home reinforcement exercises
Behavioral: Placebo Office-based Vision Therapy/Orthoptics
Vision activities designed to simulate office-based therapy

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.