Babies in Glasses: can wearing glasses for near focus help to improve sight in babies born at risk of brain injury, and in turn, help their development in other areas? A feasibility study
| ISRCTN | ISRCTN14646770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14646770 |
| ClinicalTrials.gov (NCT) | NCT05048550 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 265584 |
| Protocol serial number | Sponsor ref: 18BA36, NIHR ref: PB-PG-0418-20006, IRAS 265584, CPMS 44176 |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 23/06/2021
- Registration date
- 30/07/2021
- Last edited
- 12/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Complications can occur in infants who have loss of oxygen to their brain around the time of birth (known as Hypoxic Ischaemic Encephalopathy or HIE) and infants who are born prematurely. It is common in some children who have had complications around the time of birth to have problems with their sight as a result of cerebral visual impairment (CVI). CVI is the leading cause of sight problems in children in the UK and happens when parts of the brain and vision pathways responsible for processing vision are not working as they should.
There are different forms of CVI and the seriousness can range from small difficulties with sight to blindness. If CVI goes unnoticed, it can have a negative effect on the child’s education and quality of life.
Newborn babies are usually (but not always) long-sighted and become less long-sighted during the early months of life; a process called emmetropisation. Another change that occurs over the first few months of life is that their focusing ability develops, allowing them to change their focus from things far away to close-up objects easily. This ability to change focus is known as accommodation.
Babies use their accommodation to focus on objects close by such as their hands, toys and parents’ faces. The ability to do so is very important for their development. Many children with CVI lack good accommodation, so things that are close to them appear blurry. Glasses for long-sightedness will bring the world into focus and make everything clearer at this vital stage of development for infants with CVI.
Studies done before in older children with CVI have shown that wearing glasses for long-sightedness has improved their sight and ability to focus up close, but this has not been assessed in babies. It is well known that early correction of childhood sight problems is important because the internal changes that the brain can make in response to an injury get progressively weaker during early life.
This is a feasibility study, which means we are looking at a small sample of babies to see whether parents are willing to take part in research involving giving glasses for their babies at a young age, as well as looking at different aspects of the research plan in preparation for a larger final study.
Vision plays an important role in facilitating normal development as 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 other areas of development.
The aims of this feasibility study are:
1. To establish the willingness of parents/carers of these young babies to accept glasses at these ages.
2. Fitting and giving glasses to infants aged 8 weeks versus 16 weeks (we are quite experienced at fitting appropriate glasses for babies at these ages).
3. To establish whether patients and their parents are happy and able to follow the Optometrist advice when given glasses at 8 weeks and 16 weeks.
4. To establish whether there are any safety issues with prescribing glasses to this group of children through mechanical damage or increasing the risk of spectacle wear when these children are older.
5. To set up a patient and public involvement (PPI) committee and conduct further PPI studies to determine at what age glasses are acceptable to parents of at-risk babies.
NOTE: PPI is the way in which patients, the public, service users and carers can influence their own care and treatment, have a say in the way services are planned and run and help bring about improvements to the way care is provided.
6. To see whether we can recruit enough patients and how long it takes to do so.
7. To collect information on vision, long-or short-sightedness, ability to change focus from far to near, and developmental characteristics of infants at 8- and 16-weeks of age.
8. To see the number of families who return for their follow up visits until the study is complete in all three arms.
9. To help in our understanding of the brain haemodynamic and metabolic changes related to CVI and whether these changes can be used as early marker of disease severity. This will be tested using a light-based technique called functional broadband near infrared spectroscopy (fBNIRS).
10. The ability of the tests to correctly identify infants with improvement in visual function/development through early near vision glasses prescription in babies with and without poor accommodation.
11. Evidence for any early indicators for benefit from the glasses such as visual behaviour, long-or-short-sightedness or specific pattern of changes in brain haemodynamics and metabolism in response to a functional visual stimulus.
12. To find out what is the most appropriate and relevant cost and benefit information to collect, and how to collect this information.
Who can participate?
1. Infants born full term who have had to have brain cooling for HIE.
2. Infants born too soon (less than 29 weeks along in the pregnancy)
Infants of any sex and up until 8 weeks of age are able to take part in the study.
What does the study involve?
The infants’ vision will be assessed using a range of tests specially selected for the infants’ age. Infants in all three arms will receive a full vision assessment and eye health check at each visit. To determine if providing glasses to this patient group is helpful, there will be a ‘control group’ who will have all the vision assessments at 2 months of age but will not receive glasses (group A). Infants in group B1 and B2 will be prescribed near vision glasses (for all waking hours) at either 2 or 4-month-old, depending on randomisation.
Vision will also be measured using brain responses to light (functional broadband Near Infrared Spectroscopy or fBNIRS) to see if there are any visual processing issues. The fBNIRS will be performed for all infants before discharge and at each follow up visit.
What are the possible benefits and risks of participating?
Prescription of near vision glasses can influence emmetropisation and accommodation. Current evidence from studies of children with developmental disability indicates that:
1) Emmetropisation is not operating normally so there is less concern about disrupting a normally functioning emmetropisation process than there would be for neurotypical children and
2) In addition to the benefits in visual acuity and visual development, early near vision correction, may lead to both improved accommodation and emmetropisation.
The level of short- or long-sightedness and accommodation will be measured at 3 and 6 months after the glasses are prescribed to ensure there is no negative impact.
There is also the potential of harm to occur from a poorly fitting pair of glasses (a poorly fitting pair of glasses can cause discomfort, permanent visual harm or even deformity). Our expert paediatric dispensing optician will check the fit every few months.
Any patients with residual long-or-short-sightedness at the end of the study will be followed up in appropriate NHS clinics and the child will be in the NHS ophthalmology system much sooner than they may normally be referred (if at all) during the critical developmental period.
Where is the study run from?
University College London Hospital (UCLH) (UK)
When is the study starting and how long is it expected to run for?
August 2018 to July 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Richard Bowman, richard.bowman@gosh.nhs.uk
Contact information
Public
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
 ORCID ID |
0000-0002-2687-1926 |
|---|---|
| Phone | +44 (0)7761054397 |
| raimonda.bullaj@gosh.nhs.uk |
Public
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
| ORCID ID |
0000-0002-1531-8199 |
|---|---|
| Phone | +44 (0)20 7405 9200 ext 0145 |
| richard.bowman@gosh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomized interventional study a 3-arm parallel group open-label clinical feasibility trial for a definitive RCT with equal arm allocation and a superiority design |
| Secondary study design | Randomised parallel trial |
| Participant information sheet | 40078_PIS_v5 _16Oct2020.pdf |
| Scientific title | Can the provision of near vision glasses as an early intervention improve visual and developmental outcomes in children with perinatal brain insult? A feasibility study |
| Study acronym | BiG |
| Study objectives | Early use of glasses will improve near vision in infants at risk of development of cerebral visual impairment, leading to further improvement in other neurodevelopmental domains. This proactive intervention is hypothesised to be more effective than waiting until a problem is detected. The hypothesis for the feasibility study is that the intervention and a randomised controlled trial to investigate the above hypothesis are both feasible. |
| Ethics approval(s) | Approved 03/11/2020, South-Central Oxford C Research Ethics Committee (Level 3, Block B, Whitefriars Building, Lewins Mead, Bristol, UK BS1 2NT; +44(0)207 104 8379; oxfordc.rec@hra.nhs.uk), ref: 20/SC/0004 |
| Health condition(s) or problem(s) studied | Cerebral visual impairment |
| Intervention | Eligible children with consenting parents will be screened for severe refractive error prior to randomisation by the research optometrist. Evidence of severe refractive error will result in a referral to ophthalmology and exclusion from the study. We will randomise children using random permuted blocks. Children will be stratified and blocked by diagnosis (HIE vs preterm) and then randomised using Sealed Envelope. Children will be randomised to one of 3 arms: Group A (control arm): First assessment at 8 weeks corrected gestational age (CGA). No glasses prescribed. Group B1 (intervention arm): First assessment and given intervention at 8 weeks (CGA). Add+3.00DS to the cycloplegic refraction and prescribe. Group B2 (intervention arm): First assessment and given intervention at 16 weeks (CGA). Add+3.00DS to the cycloplegic refraction and prescribe. Full time spectacle wear is prescribed to group B1 and B2 (use of an existing product within its CE market intended purpose) and spectacles will be changed to reflect changes in refractive error or frame fit as appropriate at follow up. Random monthly interviews with a semi-structured questionnaire will be conducted on random days of the week from when they are dispensed. Infants in all 3 arms will be followed up 3- and 6-months (+/- 3 weeks) after the first assessment. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | glasses |
| Primary outcome measure(s) |
Feasibility is assessed using the acceptance of randomisation over the 10-month recruitment period – this will be measured as the proportion of patients/parents who accept the offer of randomisation |
| Key secondary outcome measure(s) |
1. 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. Time frame: 6 months |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 75 |
| Key inclusion criteria | 1. Term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE) 2. Preterm infants born at <29 weeks’ gestational age 3. No gender criteria 4. Age range: new-born to <8 weeks CGA |
| Key exclusion criteria | 1. Infants who are still an inpatient at 8 weeks CGA 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 severe refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent) |
| Date of first enrolment | 09/06/2021 |
| Date of final enrolment | 09/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
WC1E 6DB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/09/2022 | 22/09/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | version v5 | 16/10/2020 | 27/07/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40078_PIS_v5 _16Oct2020.pdf
- Participant information sheet
Editorial Notes
12/01/2024: The intention to publish date has been changed from 14/01/2024 to 14/01/2025.
28/09/2022: The contact confirmed the record is up to date.
22/09/2022: Publication reference added.
05/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 09/04/2022 to 09/09/2022.
2. The overall trial end date has been changed from 28/02/2023 to 31/07/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 28/02/2024 to 14/01/2024.
4. The ClinicalTrials.gov number has been added.
29/06/2021: Trial's existence confirmed by South-Central Oxford C Research Ethics Committee.
