Status:

COMPLETED

Assessment of an Augmented Reality Low Visual Aid in Children and Young People With Visual Impairment

Lead Sponsor:

Sheffield Children's NHS Foundation Trust

Conditions:

Vision Disability

Eligibility:

All Genders

8-16 years

Phase:

NA

Brief Summary

Approximately 24,500 children and young people (CYP) in England have a visual impairment (VI). VI refers to a loss of vision that cannot be corrected with glasses or contact lenses. Low vision aids (...

Detailed Description

This study aims to assess the impact of a head-mounted augmented reality low vision aid (SightPlus) on vision and quality of life in CYP aged 8-16 years with moderate or severe VI. There are 24,500 c...

Eligibility Criteria

Inclusion

  • Aged 8-16 years
  • Corrected visual acuity equal to lower than 6/18 and equal to or better than 3/60 with both eyes open
  • Central vision loss or vision loss affecting the whole visual field
  • Currently cared for by the Eye Department at Sheffield Children's Hospital
  • Patient and parents/guardians fluent in verbal and written English
  • No physical or cognitive difficulties which indicate the child or young person would struggle to use device or complete the study activities

Exclusion

  • Aged \<8 years or \>17 years
  • Corrected visual acuity not lower than 6/18 or equal to or better than 3/60 with both eyes open
  • History of neurological conditions, such as epilepsy or seizures
  • Children with a pacemaker or other implanted medical device
  • Not currently cared for by the Eye Department at Sheffield Children's Hospital
  • Patients or parents/guardian non-fluent in verbal and written English
  • Physical or cognitive difficulties which indicate the child or young person would struggle to use device or complete the study activities

Key Trial Info

Start Date :

October 5 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 3 2022

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT05201482

Start Date

October 5 2021

End Date

May 3 2022

Last Update

September 8 2022

Active Locations (1)

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Clinical Research Facility

Sheffield, Sheffield (South Yorkshire District), United Kingdom, S10 2TH