Back to resultsChoroidal Changes Post Short Term Exposure To Virtual Reality Devices (MIRABILE)
Primary Purpose
Myopia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visu
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Choroidal thickness, Virtual reality
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Visu OD, Control OS
Control OD, Visu OS
Arm Description
Contralateral eye study
Contralateral eye study
Outcomes
Primary Outcome Measures
Choroidal thickness
Secondary Outcome Measures
Choroidal thickness
Axial length
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04140877
Brief Title
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Acronym
MIRABILE
Official Title
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Strategy change
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visu, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Choroidal thickness, Virtual reality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, contralateral eye study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visu OD, Control OS
Arm Type
Other
Arm Description
Contralateral eye study
Arm Title
Control OD, Visu OS
Arm Type
Other
Arm Description
Contralateral eye study
Intervention Type
Device
Intervention Name(s)
Visu
Intervention Description
An experimental (test) virtual reality display
Primary Outcome Measure Information:
Title
Choroidal thickness
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Choroidal thickness
Time Frame
3 months
Title
Axial length
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FCOptom
Organizational Affiliation
Centre for Ocular Research and Education
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
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