The Role of Glasses Wearing in Amblyopia Treatment - Version 1

• Research type

  Research Study

• Full title

  The Role of Glasses Wearing in Amblyopia Treatment. A randomised controlled multicentre trial Acronym: EuPatch (European Paediatric Amblyopia Treatment Study for Children)

• IRAS ID

  120878

• Contact name

  Irene Gottlob

• Contact email

  ig15@le.ac.uk

• Research summary

  Summary of Results
  Title: The role of glasses wear in amblyopia treatment. A randomised controlled multicentre study

  We would like to take this opportunity to thank all study participants, and the funding charity Action Medical Research, without whom this important study would not be possible.

  Amblyopia, or colloquially lazy eye, is reduced vision that persists even after correction of refractive error or a structural abnormality of the eye. It is a usually unilateral condition but may be bilateral. Amblyopia is one of the most common childhood visual disorders and if left untreated can lead to serious visual impairment, which may negatively impact everyday activities. Effective treatment of amblyopia is usually only possible during childhood when there is flexibility in the developing visual system. Treatment of amblyopia accounts for a large proportion of paediatric eye clinic visits, and treatment outcomes are often suboptimal. Optimising amblyopia treatment regimes is therefore crucial for improving vision in children. Better treatment regimes would also provide cost-benefits to health services and reduce the burden on parents/guardians. Treatment of unilateral amblyopia usually consists of a period of glasses wear followed by a period of patch wearing over the better eye to bias visual stimulation to the weaker eye.

  This is the first randomised controlled trial to investigate whether doing a short period or a prolonged period of glasses wear prior to patching leads to better visual outcomes. This multicentre study was sponsored by the University of Leicester and funded by the charity Action Medical Research. No conflicts of interest are present. 30 hospital sites across the United Kingdom and mainland Europe were involved between 2013 and 2021.

  340 individuals aged 3-9 with newly diagnosed unilateral amblyopia participated in the study. Participants were randomised to either have 3-weeks or 18-weeks glasses wear prior to commencing patching treatment. These groups were stratified based on the severity of their visual deficit and the type of amblyopia (i.e. amblyopia purely due to refractive error or due to misalignment of the eye – strabismus). Their vision, binocular status and 3D depth perception was assessed every 6 weeks for the duration of the study.

  Preliminary analysis of the results indicate that at the main outcome point, after 12 weeks of patching, more participants who performed the shorter 3-week period of prior glasses wear achieved treatment success (than those who performed the longer 18-weeks of glasses wear). Further analysis of this data will uncover reasons for this result and the specific characteristics or participants who responded better to each treatment regime, full results are due to be published in a high-impact medical journal during 2022.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  13/EM/0073

• Date of REC Opinion

  28 Mar 2013

• REC opinion

  Further Information Favourable Opinion