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

V

Visu, Inc.

Status

Withdrawn

Conditions

Myopia

Treatments

Device: Visu

Study type

Interventional

Funder types

Industry

Identifiers

NCT04140877
P/689/19/VU

Details and patient eligibility

About

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.

Sex

All

Ages

13+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Visu OD, Control OS
Other group
Description:
Contralateral eye study
Treatment:
Device: Visu
Control OD, Visu OS
Other group
Description:
Contralateral eye study
Treatment:
Device: Visu

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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