| Summary: | Purpose: To determine the role of Interactive Binocular Treatment (I-BiT™) as a complementary method of patching in amblyopia therapy.
Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) between 3 and 10 years with either best corrected visual acuity (BCVA) ≤20/30 in the amblyopic eye or a difference of BCVA≥2 lines between the two eyes were included. They were randomly classified into the case and control groups (25 in each). Patching was recommended in both groups, and cases also received I-BiT™. Cases were asked to play I-BiT™ games through appropriate glasses with conjugate colored filters. Moving and fixed targets were shown to the amblyopic and non-amblyopic eyes, respectively. Playing games was continued 20 min in each session for 5 days a week within one month (total time: 6.6 h). Patching was continued for one month more in both groups to evaluate the continuous effect of I-BiT™. BCVA was measured at baseline, one month after beginning I-BiT™, and one month after cessation of I-BiT™.
Results: BCVA of amblyopic eyes in cases and controls were 0.34 ± 0.14 and 0.33 ± 0.17LogMAR at baseline which improved to 0.17 ± 0.14 and 0.26 ± 0.17 at one month, respectively. The difference was significant in each group (p < 0.001 for cases and p = 0.024 for controls) with more improvement in the case group (p < 0.001). One month after cessation of I-BiT™, BCVA difference between the two groups was not statistically significant. There was no case with recurrence of amblyopia.
Conclusion: Based on our results, I-BiT™ seems to be effective in amblyopia therapy accompanied with patching. We recommend comparing I-BiT™ alone with patching in further studies.
ClinicalTrials.gov Identifier: NCT02740725.
|
|---|
