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

NCT ID: NCT04281732

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Headset based tests

Visual task tests based on Oculus Rift

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sussex

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruth Hogg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ruth E Hogg, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NI Clinical Research Facility

Belfast, Northern Ireland, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ruth Hogg, PhD

Role: CONTACT

02890971654

Lucie Dalton, BSc

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ruth Hogg

Role: primary

028 90635018

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17/NI/0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Variability in Perimetry Study
NCT01051739 COMPLETED