Effectiveness of early spectacle intervention on visual outcomes in babies at risk of cerebral visual impairment: a parallel group, open-label, randomised clinical feasibility trial protocol

Raimonda Bullaj, Leigh Dyet, Subhabrata Mitra, Catey Bunce, Caroline S Clarke, Kathryn Saunders, Naomi Dale, Anna Horwood, Cathy Williams, Helen St Clair Tracy, Neil Marlow, Richard Bowman

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Abstract

Hypoaccommodation is common in children born prematurely and those with hypoxic ischaemic encephalopathy (HIE), with the potential to affect wider learning. These children are also at risk of longer-term cerebral visual impairment. It is also well recognised that early intervention for childhood visual pathology is essential, because neuroplasticity progressively diminishes during early life. This study aims to establish the feasibility and acceptability of conducting a randomised controlled trial to test the effectiveness of early near vision correction with spectacles in infancy, for babies, at risk of visual dysfunction. This is a parallel group, open-label, randomised controlled (feasibility) study to assess visual outcomes in children with perinatal brain injury when prescribed near vision spectacles compared with the current standard care-waiting until a problem is detected. The study hypothesis is that accommodation, and possibly other aspects of vision, may be improved by intervening earlier with near vision glasses. Eligible infants (n=75, with either HIE or
Original languageEnglish
Article numbere059946
JournalBMJ Open
Volume12
Issue number9
Early online date21 Sep 2022
DOIs
Publication statusPublished online - 21 Sep 2022

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

  • Neurology
  • 1506
  • 1713
  • OPHTHALMOLOGY
  • NEONATOLOGY
  • Neuro-ophthalmology
  • Humans
  • Infant
  • Early Intervention, Educational
  • Eyeglasses - adverse effects
  • Feasibility Studies
  • Randomized Controlled Trials as Topic
  • Mydriatics
  • Brain Diseases - complications
  • Child
  • Infant, Newborn
  • Vision Disorders - etiology - therapy

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