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Clinical Trials/NCT04786886
NCT04786886CompletedNot Applicable

Patient Performance and Acceptance of Virtual Reality Visual Field Devices

University of Miami2 sites in 1 country58 target enrollmentStarted: November 4, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
2
Primary Endpoint
Operational Effectiveness

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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.

Reliability Indices

Time Frame: Day 1

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

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alana L Grajewski

Professor

University of Miami

Study Sites (2)

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