Homonymous Hemianopia in Childhood

Homonymous Hemianopia Clinical Trial

— HHIC  

Official title:

Homonymous Hemianopia in Childhood

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06115317
• Other study ID #: 18BA25
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: October 2023
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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?".

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: July 1, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Hemianopsia
• Homonymous Hemianopia

Intervention

Other:
• Prism
Prism
• Sham
Sham

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Chidlren	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?"	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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).	2 years