NCT06115317

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

August 30, 2023

Last Update Submit

October 31, 2023

Conditions

Homonymous Hemianopia

Keywords

Homonymous HemianopiaChildren and Young People

Outcome Measures

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?"

    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?

    2 years

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

    2 years

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

    2 years

Study Arms (2)

Prism followed by sham

OTHER
Other: PrismOther: Sham

Sham followed by prism

OTHER
Other: PrismOther: Sham

Interventions

PrismOTHER

Prism

Prism followed by shamSham followed by prism
ShamOTHER

Sham

Prism followed by shamSham followed by prism

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Complete homonymous hemianopia of more than 6 months - to avoid any natural recovery or adaptation (i.e. in stroke)
  • 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)

You may not qualify if:

  • 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
  • Suspected or proven deficit of the unaffected hemisphere of the brain
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital for Chidlren

London, United Kingdom

Location

MeSH Terms

Conditions

Hemianopsia

Interventions

PRDM6, protein, mousesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jugnoo Rahi

    GOSH Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double blind cross over.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

November 3, 2023

Study Start

May 4, 2023

Primary Completion

March 31, 2024

Study Completion

July 1, 2025

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

GB(1)