JAN 24, 2022
In this Phase 3 randomized, controlled clinical trial, investigators evaluated the safety and efficacy of dichoptic amblyopia therapy vs. continued refractive correction alone in children aged 4 to 7 years with unilateral amblyopia caused by anisometropia or mild strabismus.
The trial was conducted at 21 sites in the United States and enrolled 105 children. The treatment group wore glasses full time and used the dichoptic digital device 1 hour per day for 6 days per week, while the control group only wore glasses and did not use the device. Amblyopic visual acuity (VA) was measured at 12 weeks by examiners who were masked to treatment group assignments.
After 12 weeks of treatment, the amblyopic eye in the treatment group showed a significant improvement in VA over the control group (1.8 lines vs. 0.8 lines). The study was stopped at this time due to the significant difference in VA between the groups. No serious adverse events occurred, and mild adverse events included headaches, worsening VA in either eye, and new heterotropias.
Dichoptic amblyopia therapy was only compared with continued refractive correction alone, so its relative effectiveness vs. patching or atropine penalization is unknown. As the duration of the study was limited to 12 weeks, durability of the benefit of dichoptic therapy is unknown as well. Primary outcome data were not available for 15 of the 105 participants, which may have led to bias in the findings.
This dichoptic digital device showed better adherence and thus improved VA in amblyopic eyes compared with prior devices. This is believed to be due to a more engaging patient experience and the ability of the patient to select the video content. The use of dichoptic digital therapy for amblyopia is a promising technology and may have better compliance than patching.