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An educational intervention to improve adherence to high-dosage patching regimen for amblyopia: a randomised controlled trial
  1. Archana Pradeep1,
  2. Frank Antony Proudlock1,
  3. Musarat Awan2,
  4. Glen Bush3,
  5. Jacqueline Collier4,
  6. Irene Gottlob1
  1. 1Ophthalmology Group, Faculty of Medicine & Biological Sciences, University of Leicester, Leicester, UK
  2. 2Department of Orthoptics, Nottingham University Hospitals NHS Trust, Nottingham, UK
  3. 3Medical Physics Department, Leicester Royal Infirmary, Leicester, UK
  4. 4School of Allied Health Professionals, University of East Anglia, Norwich, UK
  1. Correspondence to Professor Irene Gottlob, Ophthalmology Group, University of Leicester, Faculty of Medicine & Biological Sciences, Robert Kilpatrick Clinical Sciences Building, Leicester Royal Infirmary. PO Box 65. Leicester LE2 7LX, UK; ig15{at}le.ac.uk

Abstract

Background Previous reports suggest that adherence to patching is a major issue in amblyopia treatment. We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed.

Methods 62 children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material. Both were prescribed patching 10 h/day, 6 days/week for a fixed period of 12 weeks. The intervention arm received an educational/motivational intervention before patching which included information booklets, video, a cartoon story book, sticker charts and a dedicated session with a researcher. The control arm received the usual clinical information. The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching >4 h/day. Visual outcome, expressed as percentage visual deficit, was measured as secondary outcome.

Results The intervention increased adherence success rate from 45.2% in the control group to 80.6% in the intervention group (p=0.0027). However, visual outcome was not significantly better in the intervention group (p=0.190).

Conclusions Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed.

Trials registration number: ISRCTN05346737 (International Standard Randomised Controlled Trial Number Register).

  • Clinical Trial

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