Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

NCT04281732 | Unknown

• 1 other identifier: 17/NI/0002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

Conditions

Low Vision; Retinitis Pigmentosa; Stargardt Disease 1; Stargardt Disease 3; Stargardt Disease 4; Albinism

Keywords

Virtual Reality; Quality of life

Outcome Measures

Primary Outcomes (1)

• Test repeatability

  Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.

  All statistical analysis will take place once all data collection has ended, average 1 year.

Secondary Outcomes (1)

• Ease of use and acceptability questionnaire

  Responses from all participants will be collated and summarised at the end of the study, average 1 year.

Interventions

Virtual Reality Headset based tests DEVICE

Visual task tests based on Oculus Rift

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.

You may qualify if:

• Male and female participants
• Age 20-50
• Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
• Sight impairment criteria are as follows:
• Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
• Visual acuity of up to 6 / 24 with a moderate reduction of field of vision

You may not qualify if:

• Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
• A history of vertigo or dizziness.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University of Sussex: collaborator

Study Sites (1)

NI Clinical Research Facility

Belfast, Northern Ireland, BT9 7AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vision, Low; Retinitis Pigmentosa; Stargardt Disease; Stargardt disease 3; Stargardt disease 4; Albinism

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Macular Degeneration; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ruth E Hogg, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Hogg, PhD

CONTACT

02890971654; r.e.hogg@qub.ac.uk

Lucie Dalton, BSc

CONTACT

l.dalton@qub.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: February 24, 2020
• Study Start: October 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)