Title: Can provision of near vision glasses as an early intervention improve visual and developmental outcomes in children with perinatal brain insult? A feasibility study
Funder: Department of Health and Social Care

Abstract: Research question Can we improve vision and neurodevelopment in babies at risk of cerebral visual impairment by early intervention with near vision glasses? Background Cerebral visual impairment (CVI) is the leading cause of childhood visual impairment in the UK. Prematurity and hypoxic ischaemic encephalopathy (HIE) are major risk factors. Currently, evidence based early intervention strategies for children with CVI are lacking. Reduced accommodation is common in these children risking amblyopia, and impaired development. Yet the immediate and longer term outcomes of early intervention, by providing young children with glasses for near vision, has yet to be evaluated. Study Population: Around 100 infants who have either undergone therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE) or been born prematurely Aims and Objectives To establish the feasibility of early near vision correction with spectacles in this population. Specifically to investigate: feasibility of accurate refractive/visual assessment at 8 vs 16 weeks willingness of parents to accept full time glasses wear for their babies at 8 or 16 weeks compliance and persistence with wearing glasses for any evidence of harm from impaired emmetropisation or mechanical trauma conducting a randomized controlled trial to test the effectiveness of such an intervention. Specifically to investigate: numbers who agree to be randomised attrition during the study feedback from the participants on both the intervention (glasses) and participation in the trial the effect of the intervention on a number of visual and developmental outcomes evidence for any potential baseline clinical markers predicting benefit from the intervention Methods Consenting families of eligible babies will be recruited and randomized to 3 groups. Groups A and B1 will undergo full baseline visual and ocular assessment, including assessment of accommodation, and also near infra-red spectroscopy at 8 weeks gestational age. Group B1 will undergo the same baseline assessment at 16 weeks. Group A will get plano glasses, groups B1 and B2 will get glasses to correct for near vision (cycloplegic refraction +3.00DS add). Follow up will involve similar assessment and also assessment of compliance with glasses and will occur at 3 and 6 months after baseline. The outcomes described in objectives will be evaluated in the 3 groups at 3 and 6 months to allow analysis of feasibility of a full scale trial. Timelines for delivery Months 3-12 &ndash; recruitment of children to feasibility study (approximately 25 in each arm depending on recruitment rate). Months 6-18 &ndash; collection of follow up data from 3 and 6 month follow up visits Months 19-24 &ndash; Analyse the data from the feasibility study and preparation for main trial funding application, if the criteria for progression (sufficient recruitment, retention, absence of harm) are met. Anticipated Impact and Dissemination The intervention is a new idea, not new technology. Therefore if shown to be feasible and effective in a future full trial, it could be rolled out nationally very quickly. We will disseminate the findings as a paper in a peer reviewed journal and at professional meetings and family support groups.

Lay abstract: The leading cause of sight impairment in children in the UK is cerebral visual impairment (CVI), commonly caused by brain injury around the time of birth. Children born prematurely or needing treatment on special care baby unit, are particularly at risk. Current estimates are that 3 to 4% of children aged between 4 and 6 years may be affected. The severity of the visual impairment ranges from blindness (often with other disability) to mild problems of visual perception which may be missed until the child is much older. If we could start intervening in early life we might have more effect because there is more plasticity (suppleness) in babies brains. Also, babies use vision to learn to walk, talk, think and communicate so if we can improve vision early on we may be able to help these babies general development. What we aim to do: To offer glasses to these small babies glasses to put their near world (close up vision range) into focus, perhaps for the first time. Why we aim to do it: Previous research has shown improved vision and focusing ability with near vision glasses in older children with CVI, but it has not been tried in babies before. The close up vision range is where babies look at their hands and toys and parents faces and is crucial for development. Babies eyes are naturally in focus for distance rather than near but they can easily zoom in and change their focus to near (we all normally lose this around the age of 45). Yet many children with CVI lack the ability to change their focus and therefore miss out on this near visual stimulation at a vital stage of their development. Near vision glasses will bring this world into focus and also make everything bigger. We often refer older children with visual problems for such magnifying lenses &ndash; why not babies? How we aim to do it: We plan a trial of giving these near vision glasses to young babies whom we know to be at risk of CVI (extreme prematurity or brain injury around time of birth). We will look to see if, by doing this, we can improve children s vision when we measure it 6 months later and if we can also help other areas of development, such as accurate reaching and becoming mobile. What parents say: We have consulted with parents from the CVI society of the UK and from the neonatal clinics at UCLH, who are very enthusiastic for this research, expressing willingness to try glasses very early and wishing that their children had received earlier diagnosis and intervention for CVI.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: EYE;NEUROLOGICAL