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Published on: March 17, 2023
Effectiveness of early spectacle intervention on visual outcomes in babies at risk of cerebral visual impairment: a
Raimonda Bullaj1,2,3, Leigh Dyet2, Subhabrata Mitra2
1Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK raimonda.bullaj@gosh.nhs.uk Richard.Bowman@gosh.nhs.uk.
Insights
This study explores early spectacle use for infants at risk of visual dysfunction, including those born prematurely or with hypoxic ischaemic encephalopathy (HIE). The goal is to assess if early intervention improves visual outcomes and informs future trials.
Area of Science:
- Pediatric ophthalmology
- Neonatal neurology
- Developmental neuroscience
Background:
- Hypoaccommodation is prevalent in premature infants and those with hypoxic ischaemic encephalopathy (HIE), potentially impacting learning.
- Children with perinatal brain injury face risks of long-term cerebral visual impairment.
- Early intervention is crucial for visual pathologies due to diminishing neuroplasticity in early life.
Purpose of the Study:
- To determine the feasibility and acceptability of a randomized controlled trial (RCT) for early intervention in infant visual dysfunction.
- To investigate the effectiveness of early near vision correction with spectacles in infants at risk of visual impairment.
- To hypothesize that earlier intervention with near-vision glasses may improve accommodation and other visual functions.
Main Methods:
- A parallel-group, open-label, randomized controlled feasibility study involving 75 infants (HIE or <29 weeks gestation).
- Infants randomized into three arms: no spectacles, or spectacles prescribed at 8 or 16 weeks corrected gestational age.
- All infants received comprehensive visual and neurodevelopmental assessments at baseline and follow-up at 3 and 6 months.
Main Results:
- Feasibility and acceptability data collection on recruitment, adherence, and retention.
- Assessment of visual outcomes, including accommodation, in infants receiving early intervention versus standard care.
- Exploration of potential benefits of early spectacle wear on visual function in at-risk infants.
Conclusions:
- The study aims to provide data to inform the design of a larger RCT on early visual interventions.
- Findings will guide optimal timing and methods for spectacle prescription in infants with perinatal brain injury.
- This research addresses a critical window for intervention to mitigate long-term visual and developmental consequences.
Introduction:
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.
Methods And Analysis:
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 <29 weeks preterm) will be recruited and randomised to one of three arms, group A (no spectacles) and two intervention groups: B1 or B2. Infants in both intervention groups will be offered glasses with +3.00 DS added to the full cycloplegic refraction and prescribed for full time wear. Group B1 will get their first visit assessment and intervention at 8 weeks corrected gestational age (B1) and B2 at 16 weeks corrected gestational age. All infants will receive a complete visual and neurodevelopmental assessment at baseline and a follow-up visit at 3 and 6 months after the first visit.
Ethics And Dissemination:
The South-Central Oxford C Research Ethics Committee has approved the study. Members of the PPI committee will give advice on dissemination of results through peer-reviewed publications, conferences and societies.
Trial Registration Number:
ISRCTN14646770, NCT05048550, NIHR ref: PB-PG-0418-20006.
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