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Homonymous HemianopiaHHICNCT06115317

Homonymous Hemianopia in Childhood

A study testing Prism in people with Homonymous Hemianopia, run by Institute of Child Health 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study will consist of two connected components at a single centre. Phase 1 is observational, phenotyping children with Homonymous hemianopia (HH). Phase 2 is a pilot double blind cross over RCT in which segmental prisms are compared with sham prisms in glasses. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Homonymous Hemianopia
What is being tested?
Prism
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited Kingdom
Study dates
4 May 2023to 1 Jul 2025
Phase
Interventional
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 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Phase 1 inclusion criteria:
  • Clinical diagnosis of homonymous hemianopia
  • Age 5 to 17
  • Corrected visual acuity within normal limits for age,
  • No evidence of eye pathology (pathology of the eye its self that causes additional visual impairment on top of the homonymous hemianopia) including no nystagmus
  • No marked refractive error > +/-5.00DS
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  • Complete homonymous hemianopia of more than 6 months - to avoid any natural recovery or adaptation (i.e. in stroke)
  • Phase 2 inclusion criteria:
  • Participation in phase 1 or copy of a detailed clinical assessment in the last 6 months from GOSH or a PIC site.
  • No hemispatial visual neglect detected in phase one or a clinical assessment
  • Aged 7 to 17
  • Corrected visual acuity within normal limits for age,
  • No evidence of eye pathology (pathology of the eye its self that causes additional visual impairment on top of the homonymous hemianopia) including no nystagmus
  • No marked refractive error > +/-5.00DS
  • Complete homonymous hemianopia of more than 6 months - to avoid any natural recovery or adaptation (i.e. in stroke)

Who cannot join

  • Phase 1 exclusion criteria:
  • Cannot establish definite clinical diagnosis of homonymous hemianopia
  • Have participated in other studies undertaking intervention for homonymous hemianopia
  • Reduced corrected visual acuity for age and/or high glasses prescription.
  • Eye pathology (that causes additional visual impairment to the homonymous hemianopia) and/or nystagmus
  • Homonymous hemianopia incomplete or less than 6 months old
Show all 17Show fewer
  • Suspected or proven deficit of the unaffected hemisphere of the brain
  • Phase 2 exclusion criteria:
  • No participation in phase 1 or copy of a detailed ophthalmology assessment in the last 6 months from GOSH or a PIC site.
  • Hemispatial visual neglect
  • Cannot establish definite clinical diagnosis of homonymous hemianopia
  • Age/ability/additional disability means cannot give subjective responses
  • Have participated in other studies doing intervention for homonymous hemianopia
  • Reduced corrected visual acuity for age and/or high glasses prescription
  • Eye pathology (that causes additional visual impairment to the homonymous hemianopia) and/or nystagmus
  • Homonymous hemianopia incomplete or less than 6 months old
  • Suspected or proven deficit of the unaffected hemisphere of the brain

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Great Ormond Street Hospital for Chidlren

    London

Other trials in United Kingdom

About this study

The study will consist of two connected components at a single centre. Phase 1 is observational, phenotyping children with Homonymous hemianopia (HH). Phase 2 is a pilot double blind cross over RCT in which segmental prisms are compared with sham prisms in glasses.

Read the detailed description

The project will consist of two connected pieces of work. The primary phase of the study will examine children with a diagnosis of homonymous hemianopia to investigate the clinical spectrum, and undertake questionnaires to measure vision related quality of life and visual function. Functional evaluation will also include optical coherence tomography, electrophysiological and eye movement studies.

If the recruited children or young people meet the inclusion criteria for phase two they will then be given the option of taking part in phase 2 - a pilot randomised cross-over trial of prism glasses. The order in which the prism lenses and the sham lenses are given will be randomised, with each worn for four weeks. The child or young person and their parent carer will be asked for their opinion on each pair, with the primary outcome question "If the trial was to end today would you want to continue wearing these lenses?" (Yes/no). Visual function will be measured behaviourally using a questionnaire based tool, and functionally utilising an eye movement recording of a visual search task.

The project consists of two connected studies. The primary phase of the study will examine children with homonymous hemianopia to investigate the spectrum of eye features. This will involve doing several different eye tests, similar to ones used in clinical practice. All children will have a photo of their eye taken that measures the thickness of the nerve at the back of the eye. They will also have electrodes put on their head and around their eyes that will measure the brains response to different visual stimuli. This is not painful and they children can choose a carton to watch during it to make it more entertaining. The children will also have their eye movements measured as they follow a target on a TV screen towards the non-seeing and seeing half of the vision. The children will also be asked to do some drawing tasks such as putting numbers on a clock face, or drawing a house to see how much they do or don't ignore the side with the visual impairment. They will also undertake age appropriate questionnaires to measure their vision related quality of life and visual function. This will give us more information about what impact the HH has on different aspects of their lives.

If the recruited children in phase 1 meet the inclusion criteria for phase 2 they will be invited to take part. Phase 2 is a trial of prisms glasses. Participants will be told they are trialing two different pairs of glasses one with the full prism and one with a weaker (sham) prism, and will be unaware which one is which, as will the study investigator. The order in which they wear the glasses will be random. They will wear each pair for four weeks and return for an assessment at the end of each four weeks of wear. At each assessment the children will complete a questionnaire to measure if or how the glasses helped them.

They will also have their eye movements measured to see if they make more compensatory movements towards the blind side. Patient's opinions will also be recorded including responses to the question "If the trial was to end today would you want to continue wearing these glasses?".

Being tested
Prism, Sham
Keywords
Homonymous Hemianopia, Children and Young People
Medical subject headings
Hemianopsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrismOther

    Prism

  • ShamOther

    Sham

Study groups in NCT06115317
Study groupRoleWhat they receive
Prism followed by shamOtherNot described
Receives: Other: Prism; Other: Sham
Sham followed by prismOtherNot described
Receives: Other: Prism; Other: Sham

What is being measured

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

  1. Is it possible to run a full randomised control trial of the use of segmental prisms in children with Homonymous Hemianopia?

    My primary outcome is asking participants "if the trial ended would you want to continue wearing these glasses?"

    Measured: 2 years

Secondary outcomes (3)
  1. Is it possible to run a full randomised control trial of the use of segmental prisms in children with Homonymous Hemianopia?

    Recruitment rates using descriptive statistics.

    Measured: 2 years

  2. Is it possible to run a full randomised control trial of the use of segmental prisms in children with Homonymous Hemianopia?

    Retention rate using descriptive statistics.

    Measured: 2 years

  3. Is it possible to run a full randomised control trial of the use of segmental prisms in children with Homonymous Hemianopia?

    Reporting any harms or unintended effects (descriptive statistics).

    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 posted3 Nov 2023
  2. Study start4 May 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Double blind cross over.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115317
Sponsor's protocol ID
18BA25
Acronym
HHIC
Status last verified
Oct 2023
First submitted
30 Aug 2023
Last updated
3 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Prism in people with Homonymous Hemianopia, run by Institute of Child Health 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 15 inclusion and 17 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 3 Nov 2023. 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?

Is it possible to run a full randomised control trial of the use of segmental prisms in children with Homonymous Hemianopia? (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Nov 2023.

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