Patient Performance and Acceptance of Virtual Reality Visual Field Devices

March 3, 2021 updated by: Alana L Grajewski, University of Miami
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operational Effectiveness
Time Frame: 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.
Day 1
Medical Effectiveness as Measured by Visual Field Indexes
Time Frame: 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.
Day 1
Medical Effectiveness as Measured by Glaucoma Hemifield Test
Time Frame: 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.
Day 1
Reliability Indices
Time Frame: Day 1
Reliability index is generated based on the participants' performance in the visual field exam.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190679

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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