Clinical trial NCT06549010: Perimetric Testing With Virtual Reality
Official title: A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Perimetric test
virtual reality
Lead sponsor: Envision Health Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Illinois College of Optometry
First posted: 2024-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 30 healthy subjects 30 glaucoma subjects
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual field perimetry light sensitivity
timeFrame: 1 day
measure: Visual field perimetry foveal sensitivity
timeFrame: 1 day
measure: Visual field perimetry test duration
timeFrame: 1 day
Secondary outcomes:
measure: Optical Coherence Tomography (OCT)
timeFrame: 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois College of Optometry / Illinois Eye Institute
state: Illinois
Study officials:
affiliation: Illinois College of Optometry
name: Michael Chaglasian, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.