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NCT04994457 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04994457
Other study ID # 20210472
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 30, 2021
Est. completion date June 30, 2024

Study information
Verified date March 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 400
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Bascom Palmer Eye Institute Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Variability of Mean Deviation Variability of the mean deviation scores obtained from VRVF and SAP Day 1
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