Choroidal Changes Post Short Term Exposure To Virtual Rea... | NCT04140877

Studies
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices

NCT04140877

Sponsor

Visu, Inc.

Status

Withdrawn

Last Update Posted

Jun 4, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

Visu

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Strategy change

Expanded Access Info

Start Date

Jul 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Oct 23, 2019

First Posted Date

Oct 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Visu OD, Control OS	Other	Contralateral eye study	Device: Visu
Control OD, Visu OS	Other	Contralateral eye study	Device: Visu

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visu	Device	An experimental (test) virtual reality display	Control OD, Visu OS Visu OD, Control OS

Measure	Description	Time Frame
Choroidal thickness		2 hours

Measure	Description	Time Frame
Choroidal thickness		3 months
Axial length		3 months

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lyndon Jones, PhD, FCOptom	Centre for Ocular Research and Education	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided