ClinicalTrials.gg
Enrolling by invitationNCT06115317HHICUpdated Nov 3, 2023

Homonymous Hemianopia in Childhood

An interventional study of Prism and Sham in Homonymous Hemianopia, sponsored by Institute of Child Health. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Institute of Child Health · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 3 months after the study started (first participant enrolled May 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study 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 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?".

02

Conditions studied

  • Homonymous Hemianopia

Browse trials for

Keywords

  • Homonymous Hemianopia
  • Children and Young People
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's planned enrollment of 25 is below the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

Institute of Child Health is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Phase 1 inclusion criteria:

  1. Clinical diagnosis of homonymous hemianopia
  2. Age 5 to 17
  3. Corrected visual acuity within normal limits for age,
  4. 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
  5. No marked refractive error > +/-5.00DS
  6. Complete homonymous hemianopia of more than 6 months - to avoid any natural recovery or adaptation (i.e. in stroke)

Phase 2 inclusion criteria:

  1. Participation in phase 1 or copy of a detailed clinical assessment in the last 6 months from GOSH or a PIC site.
  2. No hemispatial visual neglect detected in phase one or a clinical assessment
  3. Aged 7 to 17
  4. Corrected visual acuity within normal limits for age,
  5. 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
  6. No marked refractive error > +/-5.00DS
  7. Complete homonymous hemianopia of more than 6 months - to avoid any natural recovery or adaptation (i.e. in stroke)

Exclusion criteria

Exclusion Criteria:

Phase 1 exclusion criteria:

  1. Cannot establish definite clinical diagnosis of homonymous hemianopia
  2. Have participated in other studies undertaking intervention for homonymous hemianopia
  3. Reduced corrected visual acuity for age and/or high glasses prescription.
  4. Eye pathology (that causes additional visual impairment to the homonymous hemianopia) and/or nystagmus
  5. Homonymous hemianopia incomplete or less than 6 months old
  6. Suspected or proven deficit of the unaffected hemisphere of the brain

Phase 2 exclusion criteria:

  1. No participation in phase 1 or copy of a detailed ophthalmology assessment in the last 6 months from GOSH or a PIC site.
  2. Hemispatial visual neglect
  3. Cannot establish definite clinical diagnosis of homonymous hemianopia
  4. Age/ability/additional disability means cannot give subjective responses
  5. Have participated in other studies doing intervention for homonymous hemianopia
  6. Reduced corrected visual acuity for age and/or high glasses prescription
  7. Eye pathology (that causes additional visual impairment to the homonymous hemianopia) and/or nystagmus
  8. Homonymous hemianopia incomplete or less than 6 months old
  9. Suspected or proven deficit of the unaffected hemisphere of the brain
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Other
    Prism followed by sham

    Other: Prism · Other: Sham

  • Other
    Sham followed by prism

    Other: Prism · Other: Sham

Interventions

  • OtherPrism

    Prism

  • OtherSham

    Sham

06

What researchers measure

Primary outcomes

  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?"

    Time frame: 2 years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 2 years

07

Study locations

1 site
  • Great Ormond Street Hospital for Chidlren
    London, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Mar 2024, 10 months after the start.

Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2023
First posted
Nov 3, 2023
StartActual
May 4, 2023
Primary completionEst.
Mar 31, 2024
CompletionEst.
Jul 1, 2025
Last update
Nov 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06115317
Lead sponsor
Institute of Child Health
Responsible party
Sponsor
First posted
Nov 3, 2023
Start date
May 4, 2023
Primary completion
Mar 31, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Nov 3, 2023

Study contacts

Jugnoo Rahi
principal investigator · GOSH Institute of Child Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion