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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04140877
Recruitment Status : Withdrawn (Strategy change)
First Posted : October 28, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Visu, Inc.

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.

Condition or disease Intervention/treatment Phase
Myopia Device: Visu Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, contralateral eye study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Visu OD, Control OS
Contralateral eye study
Device: Visu
An experimental (test) virtual reality display

Control OD, Visu OS
Contralateral eye study
Device: Visu
An experimental (test) virtual reality display




Primary Outcome Measures :
  1. Choroidal thickness [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Choroidal thickness [ Time Frame: 3 months ]
  2. Axial length [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT04140877


Sponsors and Collaborators
Visu, Inc.
Investigators
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Principal Investigator: Lyndon Jones, PhD, FCOptom Centre for Ocular Research and Education
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Responsible Party: Visu, Inc.
ClinicalTrials.gov Identifier: NCT04140877    
Other Study ID Numbers: P/689/19/VU
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Visu, Inc.:
Choroidal thickness
Virtual reality
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases