Perimetric Testing With Virtual Reality

A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.

Perimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Visual field (VF) testing provided by the HFA is standard-of-care in glaucoma clinics and other ophthalmology and optometry practices. However, the HFA is a large device that does not allow for examination outside the clinic and can be uncomfortable for patients with limited mobility.

This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. The results of this study will potentially serve as pilot data for the design of a larger study that involves the full assessment of the VR headset and its VF test, based on various testing strategies.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Diagnostic test: Perimetric test

Detailed Description

Procedures:

1. Ophthalmic screening:

   (a) Visual acuity, slit lamp exam, rebound tonometry (all subjects)

2. OCT examination of the study eye with the Topcon Maestro2 Optical Coherence Tomography (OCT):

   (a) Standard Retinal Nerve Fiber Layer (RNFL), Optic Disc and Ganglion Cell Complex (GCC) scan patterns (i) Fundus photo is automatically obtained. (b) Abnormalities consistent with ophthalmic disease will be an exclusion for the healthy group of subjects. Reasonable and common artifacts that do not significantly impair the scan report will be accepted.

   (c) OCT abnormalities consistent with glaucoma are expected on the 30 glaucoma subjects.

3. Once eligible, each patient will perform four (4) visual field tests:

   (a) once with the HFA Swedish Interactive Threshold Algorithm (SITA) Standard 24-2 pattern (i) Reliability criteria: False Positives no higher than 15% (b) three tests with the VR headset: (i) two tests with ZEST strategy (ii) one test with gamified ZEST strategy (c) Counter-balancing will be used to determine the order of (a) and (b). In particular, a study participant will either start with the HFA visual field test and then proceed to the three tests with the VR headset; or, start with the three VR tests and finish with the HFA visual field test. The sequence of the visual field tests for each study ID will be provided by the sponsor.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Chaglasian, OD; Phone Number: 312-949-7303; Email: mchaglas@ico.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Recruiting
      • Illinois College of Optometry / Illinois Eye Institute
      • Contact: Michael Chaglasian, OD; Phone Number: 312-949-7303; Email: mchaglas@ico.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion / Exclusion Criteria:

1. Age range: 25-70 years

2. For normal subjects:

   1. Patient is free of any current or prior ophthalmic pathologies that would potentially cause visual field defects: e.g. retina pathology, glaucoma, cataracts, keratoconus
   2. No ocular surgery other than cataract surgery within 6 months prior to the study visit

3. For glaucoma subjects:

   1. Patient has a diagnosis of primary open-angle glaucoma
   2. Patient is free of any other current or prior ophthalmic pathologies that would potentially cause visual field defects.
   3. No other ocular surgery other than glaucoma or cataract surgery within 6 months prior to the study visit
   4. No IOP lower than 10 mm/Hg or higher than 30 mm/Hg

4. Refractive Error:

   1. Sphere = up to -6.00 D to and up +3.00
   2. Cylinder = up to -3.00 is common
5. No past refractive eye surgery
6. No Multifocal or phakic (ICLs) IOL; no multifocal CLs
7. One eligible eye
8. Ability to sit for standard VF bowl exam. Ability to wear VR perimetry headset device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy subjects; 30 healthy subjects	Diagnostic test: Perimetric test; This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients.
Other: Glaucoma subjects; 30 glaucoma patients, 10 mild, 10 moderate, 10 severe	Diagnostic test: Perimetric test; This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual field perimetry light sensitivity	Localized differential light sensitivity threshold measured in decibels (dB)	1 day
Visual field perimetry foveal sensitivity	Foveal threshold in decibels (dB)	1 day
Visual field perimetry test duration	Test duration measured in minutes	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT) thickness values may be used, such as Retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness, measured in microns.	1 day

Collaborators and Investigators

• Sponsor: Envision Health Technologies, Inc.
• Collaborators: Illinois College of Optometry
• Investigators: Principal Investigator: Michael Chaglasian, OD, Illinois College of Optometry

Publications and helpful links

General Publications

• Montesano G, Bryan SR, Crabb DP, Fogagnolo P, Oddone F, McKendrick AM, Turpin A, Lanzetta P, Perdicchi A, Johnson CA, Garway-Heath DF, Brusini P, Rossetti LM. A Comparison between the Compass Fundus Perimeter and the Humphrey Field Analyzer. Ophthalmology. 2019 Feb;126(2):242-251. doi: 10.1016/j.ophtha.2018.08.010. Epub 2018 Aug 14.
• Marin-Franch I, Turpin A, Artes PH, Chong LX, McKendrick AM, Alawa KA, Wall M. The Open Perimetry Initiative: A framework for cross-platform development for the new generation of portable perimeters. J Vis. 2022 Apr 6;22(5):1. doi: 10.1167/jov.22.5.1.
• Marin-Franch I, Swanson WH. The visualFields package: a tool for analysis and visualization of visual fields. J Vis. 2013 Mar 14;13(4):10. doi: 10.1167/13.4.10.
• Bradley C, Ahmed IIK, Samuelson TW, Chaglasian M, Barnebey H, Radcliffe N, Bacharach J. Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment. Transl Vis Sci Technol. 2024 Mar 1;13(3):10. doi: 10.1167/tvst.13.3.10.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: virtual reality; Glaucoma; Perimetric test
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: ENV1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data and data analysis will be shared for communication of results and learning conclusions.
• IPD Sharing Time Frame: The data will submitted for publication in a medical journal, within 3-6 months of completion of the data analysis of the monitored and locked database.
• IPD Sharing Access Criteria: The trial results will be published in an open-access medical journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No