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

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.

Study Overview

• Status: Unknown
• Conditions: Retinitis Pigmentosa; Low Vision; Albinism; Stargardt Disease 1; Stargardt Disease 3; Stargardt Disease 4
• Intervention / Treatment: Device: Virtual Reality Headset based tests

Detailed Description

Aims of the Research Project:

1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
2. To quantify the reproducibility of the performance-based tests.
3. To gather acceptability and ease-of-use data from patients.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Recruiting
      • NI Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male and female participants
2. Age 20-50
3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.

4. 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use and acceptability questionnaire	Modified from Tay et al, Br J Ophthalmol 2004;88:719-720 Ask the following questions for virtual reality test: Was the test comfortable? If no- How?; Was the test too long?; How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?; How would you feel if you knew you had to perform this test at every clinic appointment?; Do you have any other comments about the test?	Responses from all participants will be collated and summarised at the end of the study, average 1 year.

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: University of Sussex

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Virtual Reality
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Skin Diseases; Eye Diseases; Neurologic Manifestations; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Eye Diseases, Hereditary; Retinal Dystrophies; Metabolism, Inborn Errors; Sensation Disorders; Amino Acid Metabolism, Inborn Errors; Pigmentation Disorders; Vision Disorders; Hypopigmentation; Macular Degeneration; Retinitis; Retinitis Pigmentosa; Vision, Low; Stargardt Disease; Albinism
• Other Study ID Numbers: 17/NI/0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No