SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter

NCT05674890 | Completed Results FDA Device

• 1 other identifier: 202206347
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare a new device for testing peripheral vision (the SmartSystem virtual reality headset) to the currently most commonly used standard testing device (the Humphrey HFA-III). The main questions this clinical trials aims to answer are:

1. 1.How comparable in performance, accuracy, and patient comfort the SmartSystem VR headset is to the Humphrey HFA-III, and
2. 2.Surveying patients about the perceived ease of use and patient experience with the SmartSystem VR headset, compared to the Humphrey HFA-III.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (3)

• Visual Field Performance Metric #1 - Mean Deviation

  Mean deviation indicates how much, on average, an entire visual field deviates from the age-normal value. It is the center-weighted average of the decibel deviations at each point tested in the visual field test. The measurement is reported in decibels.

  This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period.

• Visual Field Performance Metric #2 - Pattern Standard Deviation

  Pattern standard deviation reflects irregularities in a visual field, such as those caused by localized defects. This metric shows sensitivity losses after adjusting for generalized depression or elevation in the overall hill of vision (e.g. cataracts). The measurement is reported in decibels.

  This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period.

• Visual Field Performance Metric #3 - Test Duration

  This metric indicates how long each visual field test took to complete per eye.

  These measurements will be derived during data analysis following study completion. The exact study duration is unclear; however, we aim to recruit enough patients to analyze 80 eyes worth of data. We estimate this will take 3-6 months.

Secondary Outcomes (7)

• Visual Field User Experience Question #1 - "How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

  Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period.

• Visual Field User Experience Question #2 - "How Hard or Easy Was it to Understand the Instructions Given to You for How to do the Visual Field Test Using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

  Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period.

• Visual Field User Experience Question #3 - "How Hard or Easy Was it to Use and/or Perform the Visual Field Test Using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

  Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period.

• Visual Field User Experience Question #4 - "How Much Anxiety or Concern Did You Have About Your Test Performance While Using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

  Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period.

• Visual Field User Experience Question #5 - "Given Instruction and Training, Would You Feel Comfortable Performing Visual Field Testing by Yourself at Home Using the Smart System Virtual Reality Headset?"

  Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period.

Study Arms (2)

Group A: HFA followed by SSVR

OTHER

Patients will have one or both eyes (dependent on inclusion/exclusion criteria) tested with both the Humphrey HFA-III perimeter and the SmartSystem VR headset on the same clinic visit, spaced roughly 10-15 minutes apart. The sequence in which each patient undertakes the two tests will be randomized. Group A includes participants who tested using the HFA, followed by a 15 minute rest period, then tested with the SSVR.

Diagnostic Test: SmartSystem VR Headset perimeter

Group B: SSVR followed by HFA

OTHER

Patients will have one or both eyes (dependent on inclusion/exclusion criteria) tested with both the Humphrey HFA-III perimeter and the SmartSystem VR headset on the same clinic visit, spaced roughly 10-15 minutes apart. The sequence in which each patient undertakes the two tests will be randomized. Group B includes participants who tested using the SSVR, followed by a 15 minute rest period, then tested with the HFA.

Diagnostic Test: SmartSystem VR Headset perimeter

Interventions

SmartSystem VR Headset perimeter DIAGNOSTIC_TEST

Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.

Group A: HFA followed by SSVR; Group B: SSVR followed by HFA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18-100 years of age with suspected, mild, moderate, or severe glaucoma

You may not qualify if:

• Non-English speakers, patients with systemic or ocular disease affecting central vision, best corrected visual acuity less than 20/80, neurocognitive or psychiatric disorders that would confound visual field testing, those with physical inability to perform testing, and astigmatism with absolute values greater than 2.00 diopters

Sponsors & Collaborators

• Andrew Pouw, MD: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (6)

• Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.

  PMID: 8695555 BACKGROUND

• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

  PMID: 16488940 BACKGROUND

• Beck RW, Bergstrom TJ, Lichter PR. A clinical comparison of visual field testing with a new automated perimeter, the Humphrey Field Analyzer, and the Goldmann perimeter. Ophthalmology. 1985 Jan;92(1):77-82. doi: 10.1016/s0161-6420(85)34065-4.

  PMID: 3974997 BACKGROUND

• Hollander DA, Volpe NJ, Moster ML, Liu GT, Balcer LJ, Judy KD, Galetta SL. Use of a portable head mounted perimetry system to assess bedside visual fields. Br J Ophthalmol. 2000 Oct;84(10):1185-90. doi: 10.1136/bjo.84.10.1185.

  PMID: 11004108 BACKGROUND

• Mees L, Upadhyaya S, Kumar P, Kotawala S, Haran S, Rajasekar S, Friedman DS, Venkatesh R. Validation of a Head-mounted Virtual Reality Visual Field Screening Device. J Glaucoma. 2020 Feb;29(2):86-91. doi: 10.1097/IJG.0000000000001415.

  PMID: 31790067 BACKGROUND

• Nakai Y, Bessho K, Shono Y, Taoka K, Nakai Y. Comparison of imo and Humphrey field analyzer perimeters in glaucomatous eyes. Int J Ophthalmol. 2021 Dec 18;14(12):1882-1887. doi: 10.18240/ijo.2021.12.11. eCollection 2021.

  PMID: 34926203 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Dr. Andrew Pouw
• Organization: University of Iowa Hospitals and Clinics Department of Ophthalmology and Visual Sciences

andrew-pouw@uiowa.edu

3193562928

Study Officials

• Andrew Pouw, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The described study was a validation study comparing a novel testing device to the current clinical standard. The order of testing was randomized, so the design is that of a crossover study.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 9, 2023
• Study Start: January 3, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)