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.
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
Show all 15Show fewer
- 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.
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?".
- Conditions
- Homonymous Hemianopia
- 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 group | Role | What they receive |
|---|---|---|
| Prism followed by sham | Other | Not described Receives: Other: Prism; Other: Sham |
| Sham followed by prism | Other | Not described Receives: Other: Prism; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted3 Nov 2023
- Study start4 May 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homonymous HemianopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jugnoo Rahi, Principal investigator, GOSH Institute of Child Health
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homonymous Hemianopia in Childhood
- ClinicalTrials.gov ID
- NCT06115317
- Acronym / sponsor ID
- HHIC / 18BA25
- Conditions
- Homonymous Hemianopia
- Keywords
- Homonymous Hemianopia, Children and Young People
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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?".
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind cross over.
| Arm | Type | Receives |
|---|---|---|
| Prism followed by sham | Other | Other: Prism, Other: Sham |
| Sham followed by prism | Other | Other: Prism, Other: Sham |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrismPrism | Other | Prism followed by sham, Sham followed by prism |
| ShamSham | Other | Prism followed by sham, Sham followed by prism |
Primary outcome
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
My primary outcome is asking participants "if the trial ended would you want to continue wearing these glasses?"
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Related trials for Homonymous Hemianopia
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Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
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Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
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Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
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Home-based Vision Rehabilitation Guided by Brain Imaging
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jugnoo Rahi principal investigator
GOSH Institute of Child Health
1 site in 1 country: see every site and its status.
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.