Back to resultsPatient Performance and Acceptance of Virtual Reality Visual Field Devices
Primary Purpose
Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIrtual Reality Visual Field Exam
Sponsored by
About this trial
This is an interventional diagnostic trial for Visual Field Defect, Peripheral focused on measuring Retinal Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Any patient >13 years old at Bascom Palmer Eye Institute
- Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma
Exclusion Criteria:
- Adults unable to consent, pregnant women, prisoners
- Patients under the age of 13
Sites / Locations
- Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Reality Visual Field Group
Arm Description
Participants in this group will have virtual reality visual field testing during standard of care follow-up visit.
Outcomes
Primary Outcome Measures
Operational Effectiveness
Operational effectiveness will be reported as the length of the visit and virtual reality visual field exam testing times. Both will be measured in minutes.
Medical Effectiveness as Measured by Visual Field Indexes
Medical effectiveness will be evaluated by visual field indexes, such as mean deviation, pattern standard deviation, and foveal threshold, which are all measured in decibels. These values are generated based on the participants' performance in the visual field exam.
Medical Effectiveness as Measured by Glaucoma Hemifield Test
Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam.
Reliability Indices
Reliability index is generated based on the participants' performance in the visual field exam.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04786886
Brief Title
Patient Performance and Acceptance of Virtual Reality Visual Field Devices
Official Title
Patient Performance and Acceptance of Virtual Reality Visual Field Devices
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
Keywords
Retinal Sensitivity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Visual Field Group
Arm Type
Experimental
Arm Description
Participants in this group will have virtual reality visual field testing during standard of care follow-up visit.
Intervention Type
Other
Intervention Name(s)
VIrtual Reality Visual Field Exam
Intervention Description
Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.
Primary Outcome Measure Information:
Title
Operational Effectiveness
Description
Operational effectiveness will be reported as the length of the visit and virtual reality visual field exam testing times. Both will be measured in minutes.
Time Frame
Day 1
Title
Medical Effectiveness as Measured by Visual Field Indexes
Description
Medical effectiveness will be evaluated by visual field indexes, such as mean deviation, pattern standard deviation, and foveal threshold, which are all measured in decibels. These values are generated based on the participants' performance in the visual field exam.
Time Frame
Day 1
Title
Medical Effectiveness as Measured by Glaucoma Hemifield Test
Description
Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam.
Time Frame
Day 1
Title
Reliability Indices
Description
Reliability index is generated based on the participants' performance in the visual field exam.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient >13 years old at Bascom Palmer Eye Institute
Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma
Exclusion Criteria:
Adults unable to consent, pregnant women, prisoners
Patients under the age of 13
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Grajewski, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Performance and Acceptance of Virtual Reality Visual Field Devices
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