Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

NCT ID: NCT04140877

Last Updated: 2020-06-04

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-01-31

Brief Summary

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This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, contralateral eye study
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Visu OD, Control OS

Contralateral eye study

Group Type OTHER

Visu

Intervention Type DEVICE

An experimental (test) virtual reality display

Control OD, Visu OS

Contralateral eye study

Group Type OTHER

Visu

Intervention Type DEVICE

An experimental (test) virtual reality display

Interventions

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Visu

An experimental (test) virtual reality display

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is at least 13 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Visual Acuity of +0.20 logMAR or better in each eye;
* Is willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is amblyopic in either eye;
* Has a colour vision abnormality;
* Commonly experiences motion sickness.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Visu, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research and Education

Other Identifiers

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P/689/19/VU

Identifier Type: -

Identifier Source: org_study_id

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