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Babies in Glasses; a Feasibility Study. (BiG)

Primary Purpose

Cerebral Visual Impairment, Refractive and Accommodative Disorders, Hypoxic-Ischemic Encephalopathy

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Near vision spectacles
Sponsored by
Great Ormond Street Hospital for Children NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Visual Impairment focused on measuring Cerebral Visual Impairment, CVI, Visual Processing Disorder, Visual Perceptual Deficits, VPD, Accommodative Disorders, Hypo-accommodation, Accommodative lag, Hypoxic Ischaemic Encephalopathy, Premature Birth, Near Vision Glasses, Spectacle correction, Refractive correction, Refractive Error, Early spectacle correction, Spectacles, Glasses, Perinatal Brain Insult, Brain Injury, Neurodevelopment, Infant, Baby, Functional broadband Near Infrared Spectroscopy, fBNIRS

Eligibility Criteria

undefined - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. All term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE).
  2. All preterm infants born at <29 weeks gestational age.

Specifically, all children fulfilling these criteria will be eligible. Evidence of hypo-accommodation is not required.

Exclusion criteria:

  1. Infants that are still an inpatient at 8 weeks corrected gestational age.
  2. Ocular exclusion criteria: children with unrelated congenital or developmental ocular abnormality such as cataract requiring surgery, genetic retinal disease, coloboma. Retinopathy of prematurity will not be an exclusion criterion.
  3. Infants with high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent).

Sites / Locations

  • University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

A (control)

B1 (intervention)

B2 (intervention)

Arm Description

First visit assessments at 8 weeks corrected gestational age. No glasses prescribed.

First visit assessments at 8 weeks corrected gestational age. Full time spectacle wear prescribed.

First visit assessments at 16 weeks corrected gestational age. Full time spectacle wear prescribed.

Outcomes

Primary Outcome Measures

The acceptance of randomisation
This will be measured as the proportion of patients/parents who accept the offer of randomisation.

Secondary Outcome Measures

Success rate in dispensing glasses to children in groups B1 and B2.
The percentage of infants dispensed vs. the total number of infants randomised to the intervention arms will be recorded at the end of the study.
Success rate of compliance with glasses for infants in groups B1 and B2.
The proportion of infants (%) who are still wearing their glasses at the 3 and 6 month follow-up appointments.
Visual Acuity
The distribution of visual acuity at the 3 and 6-month follow ups compared with visual acuity at the first visit in all 3 arms.
Retention rate
This will be measured by the median number of infants reported per month.
Refractive outcomes
The distribution of refractive outcomes (measured in dioptres) at 3 and 6-month follow ups as compared to the first visit in all 3 groups.
Evidence of impaired emmetropisation following administration of FMT
This will be measured by combining refractive error and visual acuity measures. The trial will not be feasible if there is a 2SD difference without compensatory benefit eg 2 lines improvement in visual acuity.
Determination of appropriate resource-use data collection methods
A targeted paediatric client service receipt inventory (CSRI) form has been designed specifically for this population and will be used for the duration of the feasibility study.
Accommodative outcomes
The distribution of accommodative outcomes (measured in dioptres) at 3 and 6-month follow ups as compared to the first visit in all 3 groups.
Completion of compliance questionnaires
Proportion of families completing phone questionnaire on spectacle compliance as a percentage of those in the intervention groups (B1 & B2).
Significant mechanical trauma
Significant mechanical trauma will be measured as the percentage of infants who have had an adverse event (from mechanical trauma) vs. the total number of infants prescribed glasses in groups B1 and B2. The study will not be feasible if this is more than 30% of infants in the intervention arms.
Consent rate
This will be measured as the number of infants recruited vs. number of infants, who fulfil the inclusion/exclusion criteria, approached.

Full Information

First Posted
June 24, 2021
Last Updated
September 28, 2022
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University College London Hospitals, University College, London, University of Reading, University of Bristol, University of Ulster
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1. Study Identification

Unique Protocol Identification Number
NCT05048550
Brief Title
Babies in Glasses; a Feasibility Study.
Acronym
BiG
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University College London Hospitals, University College, London, University of Reading, University of Bristol, University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses. As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.
Detailed Description
The aim of this study is to assess the feasibility and the acceptability of randomisation and the intervention, namely near vision glasses, from parents of very young babies at risk of Cerebral Visual Impairment (CVI). All infants are born with an immature visual system, and for vision to develop normally, a clear image needs to transmit to the visual centres of the brain. Good vision plays an important role in facilitating normal development so if CVI goes unnoticed, it can have a damaging effect on the child's early development, and subsequent education and quality of life. Children use their sight to learn to walk, talk, think and communicate. For this reason, early intervention has the potential to have positive effects on children's vision and general development. Previous studies have shown that up to 75% of school age children, who have CVI, have difficulty focussing their eyes on a near target, so near objects, such as their hands and parents' faces, will appear blurry. These studies also showed that wearing glasses for near focus improved vision but has not been assessed in babies. This is a single-centre, parallel group, open-label feasibility trial to assess the feasibility of testing the effect near vision glasses (full cycloplegic refraction plus 3.00D add for near) could have on the visual and developmental outcome in babies at risk of brain injury. Infants at risk of developing CVI include those who have had hypoxic ischaemic encephalopathy (HIE) and those born prematurely before 29 weeks gestation. The paediatric research optometrist will enrol and assess all eligible babies of consenting families; first visit at 8 or 16 weeks corrected gestational age, depending on randomisation. Each infant will be followed up 3 months and 6-months (+/- 3 weeks) after the first visit. There are three main areas of the assessment, which will be leading to potential primary outcome measures: Visual Responses (including visual acuity and refractive status) At each visit, vision will be evaluated using Atkinson's battery for Child Development for Examining Functional Vision (ABCDEFV) according to the child's age and their ability. This comprises age-appropriate core vision tests (such as visual acuity and fixing and following) as well as additional tests that assess visual perception and visuomotor behaviour. If visual acuity cannot be obtained using Keeler acuity cards, as per ABCDEFV, the children will receive a measure using a Near Detection Scale (NDS). General Development and Neurodevelopmental Delay Non-visual developmental assessments will include the Bayley Scales of Infant Development - 3rd edition (BSID-III) assessment as appropriate for age at routine neonatal clinical appointments at 3, 6,12 and 24 months (not the research clinics). A Prechtl video will also be performed at the 3-month appointment to assess the presence of fidgety movements. The presence of these movements at 3 months corrected gestational age has been strongly correlated with normal motor development. Functional broadband near infrared spectroscopy (fBNIRS) i. Identification of changed functional haemodynamic and metabolic response to visual stimulus in infants at risk of visual dysfunction. ii. Assessment of changes in functional response in relation to response to glasses Eligible children with consenting parents will be screened for high refractive error prior to randomisation by the research optometrist to avoid post-randomisation dropouts. Evidence of high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent) will result in a referral to ophthalmology and exclusion from the study due to the possibility of associated ocular pathology with high refractive error. All of the above assessments have been organised at University College London Hospitals (UCLH). If the infant is randomised to get glasses, they will be given a near vision spectacle prescription (full cycloplegic refraction plus 3.00D add for near) to take to Great Ormond Street Hospital Eye Department dispensing optician to get the special glasses ordered. Expert ethical advice has been sought through the NIHR's Research Design Service to check on the dimension of potential harm (with a positive review). Each case will be monitored by the independent data monitoring and ethics committee (IDMEC) using follow up data who will report to the trial steering committee (TSC). The IDMEC, Trial Steering Committee (TSC) and Trial Management Group (TMG) will oversee the conduct of this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Visual Impairment, Refractive and Accommodative Disorders, Hypoxic-Ischemic Encephalopathy, Premature Birth
Keywords
Cerebral Visual Impairment, CVI, Visual Processing Disorder, Visual Perceptual Deficits, VPD, Accommodative Disorders, Hypo-accommodation, Accommodative lag, Hypoxic Ischaemic Encephalopathy, Premature Birth, Near Vision Glasses, Spectacle correction, Refractive correction, Refractive Error, Early spectacle correction, Spectacles, Glasses, Perinatal Brain Insult, Brain Injury, Neurodevelopment, Infant, Baby, Functional broadband Near Infrared Spectroscopy, fBNIRS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-centre randomised interventional study; a 3-arm parallel group, open-label clinical feasibility trial for a definitive RCT with equal arm allocation and a superiority design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A (control)
Arm Type
No Intervention
Arm Description
First visit assessments at 8 weeks corrected gestational age. No glasses prescribed.
Arm Title
B1 (intervention)
Arm Type
Experimental
Arm Description
First visit assessments at 8 weeks corrected gestational age. Full time spectacle wear prescribed.
Arm Title
B2 (intervention)
Arm Type
Experimental
Arm Description
First visit assessments at 16 weeks corrected gestational age. Full time spectacle wear prescribed.
Intervention Type
Device
Intervention Name(s)
Near vision spectacles
Intervention Description
Near vision spectacles prescribed for full time wear (Add+3.00DS to the full cycloplegic refraction). These glasses will be changed to reflect changes in refractive error or frame fit as appropriate at follow up.
Primary Outcome Measure Information:
Title
The acceptance of randomisation
Description
This will be measured as the proportion of patients/parents who accept the offer of randomisation.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Success rate in dispensing glasses to children in groups B1 and B2.
Description
The percentage of infants dispensed vs. the total number of infants randomised to the intervention arms will be recorded at the end of the study.
Time Frame
6 months
Title
Success rate of compliance with glasses for infants in groups B1 and B2.
Description
The proportion of infants (%) who are still wearing their glasses at the 3 and 6 month follow-up appointments.
Time Frame
6 months
Title
Visual Acuity
Description
The distribution of visual acuity at the 3 and 6-month follow ups compared with visual acuity at the first visit in all 3 arms.
Time Frame
6 months
Title
Retention rate
Description
This will be measured by the median number of infants reported per month.
Time Frame
15 months
Title
Refractive outcomes
Description
The distribution of refractive outcomes (measured in dioptres) at 3 and 6-month follow ups as compared to the first visit in all 3 groups.
Time Frame
6 months
Title
Evidence of impaired emmetropisation following administration of FMT
Description
This will be measured by combining refractive error and visual acuity measures. The trial will not be feasible if there is a 2SD difference without compensatory benefit eg 2 lines improvement in visual acuity.
Time Frame
6 months
Title
Determination of appropriate resource-use data collection methods
Description
A targeted paediatric client service receipt inventory (CSRI) form has been designed specifically for this population and will be used for the duration of the feasibility study.
Time Frame
15 months
Title
Accommodative outcomes
Description
The distribution of accommodative outcomes (measured in dioptres) at 3 and 6-month follow ups as compared to the first visit in all 3 groups.
Time Frame
6 months
Title
Completion of compliance questionnaires
Description
Proportion of families completing phone questionnaire on spectacle compliance as a percentage of those in the intervention groups (B1 & B2).
Time Frame
6 months
Title
Significant mechanical trauma
Description
Significant mechanical trauma will be measured as the percentage of infants who have had an adverse event (from mechanical trauma) vs. the total number of infants prescribed glasses in groups B1 and B2. The study will not be feasible if this is more than 30% of infants in the intervention arms.
Time Frame
6 months
Title
Consent rate
Description
This will be measured as the number of infants recruited vs. number of infants, who fulfil the inclusion/exclusion criteria, approached.
Time Frame
10 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: All term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE). All preterm infants born at <29 weeks gestational age. Specifically, all children fulfilling these criteria will be eligible. Evidence of hypo-accommodation is not required. Exclusion criteria: Infants that are still an inpatient at 8 weeks corrected gestational age. Ocular exclusion criteria: children with unrelated congenital or developmental ocular abnormality such as cataract requiring surgery, genetic retinal disease, coloboma. Retinopathy of prematurity will not be an exclusion criterion. Infants with high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent).
Facility Information:
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E 6DB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36130761
Citation
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. 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. 2022 Sep 21;12(9):e059946. doi: 10.1136/bmjopen-2021-059946.
Results Reference
derived

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Babies in Glasses; a Feasibility Study.

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