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Vision DisordersVINCHNCT03603301

Vision in Children Born to Opioid-dependent Methadone-maintained Mothers

An observational study of Vision Disorders and Strabismus, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators will re-investigate 150 children studied extensively in the past. 100 of these children were born to mothers prescribed methadone during their pregnancy because of opiate dependency, and 50 were comparison children who were not exposed to drugs. Read more about this study

Who is it for?
Ages 7 to 10 years
Conditions the study is for
Vision Disorders, Strabismus, Nystagmus
How many people
200 participants
Where
1 siteUnited Kingdom
Study dates
1 Jul 2017to Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 10 years
  • All sexes
  • Child

Study population: 100 drug-exposed neonates and 50 comparison infants, all born between 13/08/2008 and 30/04/2009 at the Princess Royal Maternity in Glasgow, previously recruited to the VIDI study; an additional 50 classroom comparison children.

Who may be able to join

  • cases: born to opioid-dependent mothers prescribed substitute methadone during pregnancy and delivered after 36 completed weeks' gestation.
  • comparisons: healthy, non drug-exposed infants delivered within the same maternity unit, matched for gestation, birthweight ± 250g and Carstairs deprivation score ± 1; attempted match for smoking

Who cannot join

  • congenital ocular abnormality; significant neonatal illness

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Children's Clinical Research Facility (CRF), Queen Elizabeth University Hospital

    Glasgow, G51 4TF

Other trials in United Kingdom

About this study

The investigators will re-investigate 150 children studied extensively in the past. 100 of these children were born to mothers prescribed methadone during their pregnancy because of opiate dependency, and 50 were comparison children who were not exposed to drugs. These children were investigated when they were newborn babies, and again when they were six months old, and a quarter of the drug-exposed babies had problems with their eyesight, whilst very few of the comparison children has eyesight problems. The investigators would like to see whether the eyesight problems are still present in the children now that they are older. Because they are older, more detailed testing can be undertaken which will help to understand how drug exposure in the womb may have affected their eyesight. The investigators will recruit new, comparison children to the study to match the number of comparison children with the number of drug-exposed children. The findings will be relevant and important when advising mothers on drug use - both prescribed and illicit - when they are pregnant.

Read the detailed description

Multiple researchers across the world over many decades have noted eyesight problems in children born to mothers who use drugs during pregnancy. From our earlier work on this group of children, we have detailed knowledge of which drugs each mother used, making this group of children uniquely important for understanding the consequences of drug use during pregnancy. Although methadone use in the UK is dropping as heroin misuse falls, there is currently an international epidemic of babies being born to mothers using illicit or prescribed opioid drugs (e.g. methadone, heroin, opiate-based painkillers). These babies may be at risk of the same eyesight problems as this Scottish cohort. Knowing the longer-term consequences and disseminating the findings to relevant international clinical groups could help to alleviate the consequential damage, through better information for mothers and through better and prompter management of affected children.

The study is planned to run for 2 years. It is anticipated that a maximum of 65 drug-exposed children (out of the original 100) will attend, and will therefore aim to also investigate 65 comparison children, as many as possible of whom will belong to the original cohort of 50 comparison children.

Testing will take place in the Children's Clinical Research Facility (CRF), on the campus of the Queen Elizabeth University Hospital and Royal Hospital for Children, Glasgow. A CRF paediatric nurse will recruit, coordinate and administrate the study. They will manage the child's progress through the assessment session, measure height, weight and head circumference, document demographic, social and educational details from the child's carer, and will apply two questionnaires to the carers. Eyesight tests will be done by a specialist paediatric orthoptist, and will include acuity (the smallest letter correctly identified), stereoacuity (perception of depth) and looking for squints or nystagmus (shaking or wobbling of the eyes).

Highly specialised eye tests (eye movement recordings and visual evoked potentials) will also be undertaken.

If any abnormalities are noted from these tests, the child will be given eyedrops to dilate their pupils. All children will be seen by a paediatric ophthalmologist who will look at the back of their eyes, and check whether they need glasses, or whether their glasses are correct. A medical history will be taken. If any problems are noted during the visit (e.g. visual, medical, social), the child will be referred to relevant services after discussion with their carer.

The data will be added to the existing database for these children, and the test results correlated with the results found at birth and at six months, and with the any known drug exposure of each child.

Medical subject headings
Vision Disorders, Strabismus, Nystagmus, Pathologic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. presence of strabismus, nystagmus, reduced acuity, significant refractive error

    natural history of visual abnormalities following in utero exposure to methadone +/- other drugs

    Measured: 2 years

Secondary outcomes (1)
  1. correlation of abnormality or normality with prenatal drug exposure

    to map visual findings to the known prenatal drug exposure and infant visual findings for each child

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start1 Jul 2017
  3. Primary completionFeb 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603301
Sponsor's protocol ID
GN16OP130p
Acronym
VINCH
Status last verified
Jul 2018
First submitted
22 Mar 2017
Last updated
1 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hamilton R, Mulvihill A, Butler L, Chow A, Irving E, McCulloch DL, McNeil A, Michael K, Spowart KM, Waterson-Wilson J, Mactier H. Impaired vision in children prenatally exposed to methadone: an observational cohort study. Eye (Lond). 2024 Jan;38(1):118-126. doi: 10.1038/s41433-023-02644-3. Epub 2023 Jul 4.

    PubMed 37402864

Questions about this trial

What is this clinical trial studying?

An observational study of Vision Disorders and Strabismus, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of strabismus, nystagmus, reduced acuity, significant refractive error (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.

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