Amblyopia (lazy eye) Eye Diseases Amblyopia ex anopsia
Conditions
Interventions
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.
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
Exclusion criteria: 1. Stimulus deprivation amblyopia 2. Ocular co-morbidities that would affect final visual outcomes (e.g. albinism, nystagmus, coloboma, retinal dystrophies, lens opacities, corneal dystrophies, keratoconus) 3. Previous occlusion therapy 4. Developmental/learning difficulties that preclude accurate assessment of vision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity measured in LogMAR at 25 and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed