Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

NCT04140877 | Withdrawn

• 1 other identifier: P/689/19/VU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

Choroidal thickness; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  2 hours

Secondary Outcomes (2)

• Choroidal thickness

  3 months

• Axial length

  3 months

Study Arms (2)

Visu OD, Control OS

OTHER

Contralateral eye study

Device: Visu

Control OD, Visu OS

OTHER

Contralateral eye study

Device: Visu

Interventions

Visu DEVICE

An experimental (test) virtual reality display

Control OD, Visu OS; Visu OD, Control OS

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visu, Inc.: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, contralateral eye study

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 28, 2019
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share