Imaging of Convergence Insufficiency Treatment Effects (ICITE) Pilot Study: Design and Methods

Background: The blood-oxygen-level-dependent (BOLD) signal from functional magnetic resonance imaging (fMRI) identifies brain activation during specific tasks.1,2 This paper describes the design and methodology of the Imaging of Convergence Insufficiency Treatment Effects (ICITE) Study, a two-phase study comparing BOLD activations during vergence eye movements in symptomatic convergence insufficiency (CI) subjects (1) to those with normal binocular vision (NBV) and (2) after office-based vergence/accommodative therapy (OBVAT) versus office-based placebo therapy (OBPT). Methods: Young adults, 18 to 30 years, with NBV or symptomatic CI (near exophoria at least 4Δ [prism diopters] greater than at distance, receded near point of convergence [NPC], and insufficient positive fusional vergence [PFV]) were enrolled. During fMRI scanning, subjects were instructed to fuse a random-dot stereogram stimulus with vergence demands ranging from -3Δ to +25Δ. CI subjects were then randomized to 12 weeks of OBVAT or OBPT. Vision and fMRI examination at outcome were performed by a masked examiner. BOLD signal at baseline was compared between NBV and CI patients. Later, the BOLD response at baseline was compared to that following vision therapy for those with CI. Conclusion: The imaging results are expected to advance understanding of neurological mechanisms of CI and the effects of therapy on the vergence system, which in turn may guide development of future research that could lead to new treatment strategies.