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

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ClinicalTrials.gov Identifier: NCT04281732
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
University of Sussex
Information provided by (Responsible Party):
Ruth Hogg, Queen's University, Belfast

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.


Condition or disease Intervention/treatment
Low Vision Retinitis Pigmentosa Stargardt Disease 1 Stargardt Disease 3 Stargardt Disease 4 Albinism 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020



Intervention Details:
  • Device: Virtual Reality Headset based tests
    Visual task tests based on Oculus Rift


Primary Outcome Measures :
  1. Test repeatability [ Time Frame: All statistical analysis will take place once all data collection has ended, average 1 year. ]
    Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.


Secondary Outcome Measures :
  1. Ease of use and acceptability questionnaire [ Time Frame: Responses from all participants will be collated and summarised at the end of the study, average 1 year. ]

    Modified from Tay et al, Br J Ophthalmol 2004;88:719-720

    Ask the following questions for virtual reality test:

    1. Was the test comfortable? If no- How?
    2. Was the test too long?
    3. How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?
    4. How would you feel if you knew you had to perform this test at every clinic appointment?
    5. Do you have any other comments about the test?



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281732


Contacts
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Contact: Ruth Hogg, PhD 02890971654 r.e.hogg@qub.ac.uk
Contact: Lucie Dalton, BSc l.dalton@qub.ac.uk

Locations
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United Kingdom
NI Clinical Research Facility Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Contact: Ruth Hogg    028 90635018    r.e.hogg@qub.ac.uk   
Sponsors and Collaborators
Queen's University, Belfast
University of Sussex
Investigators
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Principal Investigator: Ruth E Hogg, PhD Queen's University, Belfast
  Study Documents (Full-Text)

Documents provided by Ruth Hogg, Queen's University, Belfast:
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Responsible Party: Ruth Hogg, Principal Investigator, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT04281732    
Other Study ID Numbers: 17/NI/0002
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruth Hogg, Queen's University, Belfast:
Virtual Reality
Quality of life
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Nervous System Diseases
Skin Diseases, Genetic
Pigmentation Disorders
Skin Diseases
Metabolic Diseases
Vision, Low
Retinitis
Retinitis Pigmentosa
Macular Degeneration
Albinism
Retinal Dystrophies
Retinal Degeneration
Neurologic Manifestations
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Hypopigmentation