Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Occlusion Treatment of Amblyopia Study (ROTAS): Trial of Maximal Vs Substantial Doses of Occlusion to Evaluate Visual Outcome for Children With Amblyopia
Brief Summary: Amblyopia ('lazy eye') is the commonest visual disorder of childhood and is caused by an interruption to visual development. Occlusion of the better eye by patching is the mainstay of treatment, so forcing use, of the affected eye. We have little understanding of how much treatment is required for improvement, so occlusion may continue for many months. This is both demanding for the child and family as a whole. Treatment outcome is frequently unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment the child actually receives or how much is required.

To overcome this, we have designed an instrument that permits us to measure occlusion: an occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child actually receives. Recently we have observed that 75% of improvement induced by occlusion occurs in the first four weeks of treatment. In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - i.e. treatment will be more efficient, more effective, and more 'family-friendly'. The study hypothesis is that 12 hours/day of patching is more effective than 6 hours/day.


Options:
A: Arm Label: I-BiTTM game; Type: EXPERIMENTAL; Interventions: Device: I-BiTTM game | Arm Label: Non-I-BiTTM game; Type: ACTIVE_COMPARATOR; Interventions: Device: Non-I-BiTTM game | Arm Label: I-BiTTM DVD; Type: EXPERIMENTAL; Interventions: Device: I-BiTTM DVD | Intervention Type: DEVICE; Name: I-BiTTM game; Assigned to Arm(s): I-BiTTM game | Intervention Type: DEVICE; Name: Non-I-BiTTM game; Assigned to Arm(s): Non-I-BiTTM game | Intervention Type: DEVICE; Name: I-BiTTM DVD; Assigned to Arm(s): I-BiTTM DVD
B: Arm Label: Recommendation of Patching; Type: ACTIVE_COMPARATOR; Interventions: Other: Patching Therapy | Arm Label: Recommendation of Patching and interactive binocular treatment; Type: ACTIVE_COMPARATOR; Interventions: Other: Patching Therapy, Device: Interactive Binocular Treatment System | Intervention Type: OTHER; Name: Patching Therapy; Assigned to Arm(s): Recommendation of Patching, Recommendation of Patching and interactive binocular treatment | Intervention Type: DEVICE; Name: Interactive Binocular Treatment System; Assigned to Arm(s): Recommendation of Patching and interactive binocular treatment
C: Arm Label: Binocular Computer Game Treatment; Type: EXPERIMENTAL; Interventions: Other: iPad® | Arm Label: Continued Spectacle Correction; Type: ACTIVE_COMPARATOR; Interventions: Other: Spectacle correction | Intervention Type: OTHER; Name: iPad®; Assigned to Arm(s): Binocular Computer Game Treatment | Intervention Type: OTHER; Name: Spectacle correction; Assigned to Arm(s): Continued Spectacle Correction
D: Intervention Type: DEVICE; Name: 6 hours occlusion by patching; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: 12 hours occlusion by patching; Assigned to Arm(s): N/A

Answer: D