Patient Performance and Acceptance of Virtual Reality Visual Field Devices

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT04786886
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 3.9

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
Visual Field Defect, Peripheral; Visual Field Defect, Nasal Step; Visual Field Defect, Paracentral Scotoma of Both Eyes	Other: VIrtual Reality Visual Field Exam	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Patient Performance and Acceptance of Virtual Reality Visual Field Devices
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Feb 2, 2021
• Actual Study Completion Date: Feb 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality Visual Field Group Participants in this group will have virtual reality visual field testing during standard of care follow-up visit.	Other: VIrtual Reality Visual Field Exam; Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.

Outcome Measures

Primary Outcome Measures

1. Operational Effectiveness [Day 1]

   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.

2. Medical Effectiveness as Measured by Visual Field Indexes [Day 1]

   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.

3. Medical Effectiveness as Measured by Glaucoma Hemifield Test [Day 1]

   Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam.

4. Reliability Indices [Day 1]

   Reliability index is generated based on the participants' performance in the visual field exam.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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 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: NCT04786886
• Other Study ID Numbers: 20190679
• First Posted: Mar 8, 2021
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Alana L Grajewski, Professor, University of Miami: Retinal Sensitivity
• Additional relevant MeSH terms: Scotoma

Study Results

No Results Posted as of Mar 8, 2021