Choroidal Changes Post Short Term Exposure To Virtual Reality Devices (MIRABILE)

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.

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Device: Visu

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Visu OD, Control OS; Contralateral eye study	Device: Visu; An experimental (test) virtual reality display
Other: Control OD, Visu OS; Contralateral eye study	Device: Visu; An experimental (test) virtual reality display

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Choroidal thickness	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Axial length	3 months
Choroidal thickness	3 months

Collaborators and Investigators

• Sponsor: Visu, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Virtual reality; Choroidal thickness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P/689/19/VU

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
• product manufactured in and exported from the U.S.: Yes