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

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

Miss Raimonda Bullaj
Public

Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

ORCID ID	0000-0002-2687-1926
Phone	+44 (0)7761054397
Email	raimonda.bullaj@gosh.nhs.uk

Mr Richard Bowman
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
Email	richard.bowman@gosh.nhs.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Great Ormond Street Hospital for Children NHS Foundation Trust
Hospital/treatment centre

Great Ormond Street Hospital
Great Ormond Street
London
WC1V 3JH
England
United Kingdom

Phone	+44 (0)207 905 2271
Email	research.governance@gosh.nhs.uk
Website	http://www.gosh.nhs.uk/
"ROR"	https://ror.org/03zydm450

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

40078_PIS_v5 _16Oct2020.pdf

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.