Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04994457

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Virtual Reality Visual Field Diagnostic Test: Standard Automated Perimetry

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Adults with Glaucoma or Suspected Glaucoma Adults with Glaucoma or Suspected Glaucoma, who have previously had standard automated perimetry (SAP) and will receive virtual reality visual field (VRVF) as part of the standard of care	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses
Visual Field Naive Adults Visual Field Naive Adults will receive SAP and VRVF	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses Diagnostic Test: Standard Automated Perimetry Standard of care perimeter
Children with Glaucoma or Suspected Glaucoma Children with Glaucoma or Suspected Glaucoma, who have previously had SAP and will receive VRVF as part of the standard of care	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses
Visual Field Naive Children Visual Field Naive Children will receive SAP and VRVF	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses Diagnostic Test: Standard Automated Perimetry Standard of care perimeter
Remote Care Arm Glaucoma or Suspected Glaucoma participants, who have previously had SAP and will receive VRVF at their home	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses
Ptosis Arm Patients diagnosed with Ptosis, brow ptosis, or dermatochalasis, will receive a specialized version of VRVF and SAP, specifically to detect ptosis	Device: Virtual Reality Visual Field A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses Diagnostic Test: Standard Automated Perimetry Standard of care perimeter

Outcome Measures

Primary Outcome Measures

Sensitivity of VRVF compared to SAP [Day 1]
Sensitivity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP
Specificity of VRVF compared to SAP [Day 1]
Specificity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP

Secondary Outcome Measures

Variability of Mean Deviation [Day 1]
Variability of the mean deviation scores obtained from VRVF and SAP

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion:

Any individual who is physically able to take a virtual reality visual field test
Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)

Exclusion:

Adults unable to consent, prisoners
Participants who are too tired to take a visual field test
Participants who refuse to consent
Individuals who are functionally unable to use VRVF

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bascom Palmer Eye Institute	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Alana L Grajewski, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alana L Grajewski, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04994457

Other Study ID Numbers:

20210472

First Posted:

Aug 6, 2021

Last Update Posted:

Jan 14, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Alana L Grajewski, Professor, University of Miami

Visual Field

Virtual Reality

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Jan 14, 2022