Effectiveness of optical treatment in amblyopia and validation of measuring spectacle compliance with the ODM.

Purpose: The improvement in visual acuity (VA) was determined during optical treatment in children with amblyopia before their participation in a randomised clinical trial comparing the effect of dichoptic video gaming using virtual reality goggles with occlusion therapy.

Methods: Children aged 4-12 years with an interocular VA difference ≥0.20 logMAR and an amblyogenic factor: strabismus <30Δ, ≥1.00 D anisometropia, astigmatism ≥1.50 D and/or hypermetropia ≥1.50 D were eligible for 16 weeks of optical treatment. Children with previous amblyopia treatment were excluded. Compliance with spectacle wear was measured electronically over 1 week using the occlusion dose monitor (ODM). The reliability of these measurements was verified. The main outcome was an increase in amblyopic eye VA from baseline to 16 weeks.

Results: Sixty-five children entered the optical treatment period. Mean age was 6.0 ± 2.2 years (range: 4-12 years; IQR 4.5-6.7 years). Amblyopia was caused by anisometropia in 53 (82%) children, strabismus in 6 (9%) and combined mechanism in 6 (9%). After optical treatment, mean VA improved by 0.20 logMAR (SD 0.28; p < 0.001) and 0.07 in the amblyopic and fellow eye, respectively (SD 0.20; p = 0.03). This resulted in 24 children (37%) with an interocular VA difference <0.20 logMAR and in 17% of children with VA at the start of 0.30 logMAR or worse. Poor VA in the amblyopic eye at baseline (p = 0.001) and high anisometropia (p = 0.001) were associated with VA improvement. On average, spectacles were worn 9.7 ± 2.4 h/day (range: 2.3-13.6 h); mean compliance was 73% ± 18% of estimated wake time. Only ambient temperature ≥ 31°C or when spectacles were worn on top of the head prevented a reliable ODM measurement.

Conclusions: VA improved by two lines resulting in more than a third of the children being treated sufficiently with spectacles alone and no longer being classified as amblyopic. The ODM proved to be a reliable method of measuring compliance with spectacle wear.