Patient Performance and Acceptance of Virtual Reality Visual Field Devices

Visual Field Defect, Peripheral Clinical Trial

Official title:

Patient Performance and Acceptance of Virtual Reality Visual Field Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786886
• Other study ID #: 20190679
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Reliability Indices	Reliability index is generated based on the participants' performance in the visual field exam.	Day 1