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

doi:10.1136/bmjopen-2021-059946

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

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.

Original language	English
Article number	e059946
Journal	BMJ Open
Volume	12
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2021-059946
Publication status	Published - 21 Sept 2022

Bibliographical note

Funding Information:
This work was supported by the NIHR Central Commissioning Facility (grant number PB-PG-0418-20006/Grant name -NIHR RfPB). CB’s post is part funded by the NIHR BRC at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research London.

Publisher Copyright:
©

Keywords

Brain Diseases/complications
Child
Early Intervention, Educational
Eyeglasses/adverse effects
Feasibility Studies
Humans
Infant
Infant, Newborn
Mydriatics
Randomized Controlled Trials as Topic
Vision Disorders/etiology

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Bullaj, R., Dyet, L., Mitra, S., Bunce, C., Clarke, C. S., Saunders, K., Dale, N., Horwood, A., Williams, C., St Clair Tracy, H., Marlow, N., & Bowman, R. (2022). 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. BMJ Open, 12(9), Article e059946. https://doi.org/10.1136/bmjopen-2021-059946

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

note = "Funding Information: This work was supported by the NIHR Central Commissioning Facility (grant number PB-PG-0418-20006/Grant name -NIHR RfPB). CB{\textquoteright}s post is part funded by the NIHR BRC at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research London. Publisher Copyright: {\textcopyright}",

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doi = "10.1136/bmjopen-2021-059946",

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Bullaj, R, Dyet, L, Mitra, S, Bunce, C, Clarke, CS, Saunders, K, Dale, N, Horwood, A, Williams, C, St Clair Tracy, H, Marlow, N & Bowman, R 2022, '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', BMJ Open, vol. 12, no. 9, e059946. https://doi.org/10.1136/bmjopen-2021-059946

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. / Bullaj, Raimonda; Dyet, Leigh; Mitra, Subhabrata et al.
In: BMJ Open, Vol. 12, No. 9, e059946, 21.09.2022.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Effectiveness of early spectacle intervention on visual outcomes in babies at risk of cerebral visual impairment

T2 - a parallel group, open-label, randomised clinical feasibility trial protocol

AU - Bullaj, Raimonda

AU - Dyet, Leigh

AU - Mitra, Subhabrata

AU - Bunce, Catey

AU - Clarke, Caroline S

AU - Saunders, Kathryn

AU - Dale, Naomi

AU - Horwood, Anna

AU - Williams, Cathy

AU - St Clair Tracy, Helen

AU - Marlow, Neil

AU - Bowman, Richard

N1 - Funding Information: This work was supported by the NIHR Central Commissioning Facility (grant number PB-PG-0418-20006/Grant name -NIHR RfPB). CB’s post is part funded by the NIHR BRC at the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research London. Publisher Copyright: ©

PY - 2022/9/21

Y1 - 2022/9/21

N2 - 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.

AB - 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.

KW - Brain Diseases/complications

KW - Child

KW - Early Intervention, Educational

KW - Eyeglasses/adverse effects

KW - Feasibility Studies

KW - Humans

KW - Infant

KW - Infant, Newborn

KW - Mydriatics

KW - Randomized Controlled Trials as Topic

KW - Vision Disorders/etiology

U2 - 10.1136/bmjopen-2021-059946

DO - 10.1136/bmjopen-2021-059946

M3 - Article (Academic Journal)

C2 - 36130761

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e059946

ER -

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

Abstract

Bibliographical note

Keywords

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