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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Virtual Reality Visual Field; Diagnostic test: Standard Automated Perimetry

• Study Type: Observational
• Enrollment (Actual): 287

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of VRVF compared to SAP	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	Day 1
Specificity of VRVF compared to SAP	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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of Mean Deviation	Variability of the mean deviation scores obtained from VRVF and SAP	Day 1

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Elena Bitrian, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2021
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Visual Field
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 20210472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No