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
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.
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?".
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 →Institute of Child Health is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Phase 1 inclusion criteria:
Phase 2 inclusion criteria:
Exclusion Criteria:
Phase 1 exclusion criteria:
Phase 2 exclusion criteria:
Other: Prism · Other: Sham
Other: Prism · Other: Sham
Prism
Sham
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
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
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
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
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.
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Institute of Child Health