Low- or high-intensity patching for lazy eye

INTERVENTION: Aim 1: A randomized, controlled, multi‐centre (within a single Trust) feasibility trial, comparing low (treatment‐as‐usual (TAU)) to high‐intensity (full‐time (FTO)) patching. Pre‐randomisation Moorfields operates a Trust‐wide opt‐out process for patients being approached for participation in research studies. Thus, the researchers will only consider the eligibility of patients who have not opted out to be contacted for research. Eligible patients will be identified by the Fellow (DEP), managing clinicians and NIHR BRC staff and will be approached, with their parents, to participate during their routine clinical visit. They will be provided with written information about the study, including age‐appropriate information for children, and offered an opportunity to ask questions. Informed, written consent will be sought by the Fellow from parents/guardians who choose to participate. Randomisation and masking Computer‐generated permuted block randomisation, stratified by site and age. Children will be asked to perform the required occlusion dose by the Fellow (either TAU or FTO). To facilitate communication about treatment adherence, examiners will be not be masked to the treatment group. It is not possible to mask children/their parents to their treatment allocation. Procedure Participants will remain in standard clinics, with routine orthoptic measurements taken every 5 weeks (± 1 week) for 25 weeks for those undertaking FTO, and every 8‐12 weeks for TAU. TAU matches current standard care exactly. Parents will be asked to fit Theramon® dose monitors when undertaking occlusion. Data will be taken from dose moni CONDITION: Amblyopia (lazy eye) ; Eye Diseases ; Amblyopia ex anopsia PRIMARY OUTCOME: Visual acuity measured in LogMAR at 25 and 52 weeks SECONDARY OUTCOME: ; 1. Patient‐reported outcomes of interest derived from interviews at the beginning, middle and end of treatment and focus groups at the end of the study; 2. Number of eligible patients per hospital/year (for external sites) measured using data collection sheets over a 1‐year period; 3. Participation rate (number recruited/number approached) measured using a participant logbook over a 1‐year period; 4. Willingness of participants/families to be randomised, ascertained by interview at their first visit; 5. Drop‐out/attendance rates measured using data collection sheets at each clinical visit; 6. Usability of occlusion dose monitors (ODMs) by patient report at each clinical visit; 7. Evaluation of outcome measures to include in a cost‐effectiveness model in a fully‐powered RCT (e.g. out‐of‐pocket costs measured using questionnaires at clinical visits); 8. Treatment adherence rates and acceptability of high‐intensity occlusion measured using occlusion dose monitors at each clinical visit; INCLUSION CRITERIA: 1. Patients attending paediatric clinics at three large Moorfields sites. City Road (Central/East London) sees 60% of all paediatric cases, Northwick Park (North‐West London) has 6.5%, and St. George’s Hospital (South‐East London) 5.5% of paediatric cases 2. Aged 4‐17 years 3. Able to perform crowded LogMAR acuity testing with letters (using a matching card if necessary) 4. Mild/moderate amblyopia, defined as interocular difference in vision =0.2 LogMAR, and VA worse than 0.2 LogMAR, but better than 0.7 LogMAR in the amblyopic eye after full refractive adaptation (a minimum of 18 weeks glasses wear, with proven stability (<0.075 LogMAR change in vision between two separate visits)) 5. Cycloplegic refraction within the last 6 months and up‐to‐date glasses (if required)