Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

Myopia Clinical Trial

— MIRABILE  

Official title:

Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04140877
• Other study ID #: P/689/19/VU
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: January 2021

Study information

• Verified date: June 2020
• Source: Visu, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Visu
An experimental (test) virtual reality display

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Visu, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal thickness		2 hours
Secondary	Choroidal thickness		3 months
Secondary	Axial length		3 months