Comparison between Patching and Interactive Binocular Treatment (I-BiTTM) in Amblyopia: A Randomized Clinical Trial

Purpose: To compare the effect of amblyopia therapy on cases who received Interactive Binocular Treatment (IBiTTM) with those who received standard patching of the dominant eye with placebo I-BiTTM. Methods: In this randomized clinical trial, 38 unilateral amblyopic children (3 to 10 years old) were studied. All unilateral amblyopic children who had best corrected visual acuity (BCVA) worse than 0.30LogMAR or a difference of two Snellen lines of BCVA between their two eyes were included and children who did not complete at least 75% of amblyopia treatment were excluded from this study. Eventually, a total of 19 and 21 subjects were included in case and control groups, respectively. Cases played I-BiT™ games, while controls had standard patch therapy and played with placebo I-BiTTM games, both for one month. All subjects were examined at baseline and after one-month therapy. Results: BCVA improved significantly in both groups after one-month treatment (case: P=0.003, control:P<0.001), while in comparison with each other, there was not any difference between them (P=0.52). Although stereopsis improved in case (P<0.001) and control (P<0.001), there was no significant difference between them pre and post therapy. Our children played games totally for about 6 hours during one month in both groups and their compliance were 87.5% and 76% in cases and controls, respectively. Two children were excluded due to their less compliance of playing I-BiTTM games (n=38). Conclusion: I-BiTTM game and patching with placebo game had similar BCVA improvement in amblyopic children after one-month treatment. It is suggested to conduct further randomized clinical trials with larger sample size and longer duration of study and assessment of its recurrence