Patient Performance and Acceptance of Virtual Reality Visual Field Devices

NCT04786886 | Completed

• 1 other identifier: 20190679
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Visual Field Defect, Peripheral; Visual Field Defect, Nasal Step; Visual Field Defect, Paracentral Scotoma of Both Eyes

Keywords

Retinal Sensitivity

Outcome Measures

Primary Outcomes (4)

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 1

• Reliability Indices

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

  Day 1

Study Arms (1)

Virtual Reality Visual Field Group

EXPERIMENTAL

Participants in this group will have virtual reality visual field testing during standard of care follow-up visit.

Other: VIrtual Reality Visual Field Exam

Interventions

VIrtual Reality Visual Field Exam OTHER

Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.

Virtual Reality Visual Field Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adults unable to consent, pregnant women, prisoners
• Patients under the age of 13

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Study Officials

• Alana Grajewski, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: November 4, 2019
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)