NCT00338611

Convergence Insufficiency Treatment Trial (CITT)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: National Eye Institute (NEI) · NIH
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Convergence Insufficiency
• Binocular Vision Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-09-01
• Completion: 2009-09-01
• First posted: 2006-06-20
• Last updated: 2010-03-25

Locations

9 sites across 1 country: United States