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NCT Number: NCT06549010

Perimetric Testing With Virtual Reality

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.

Recruiting

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illinois College of Optometry / Illinois Eye Institute

Chicago, Illinois, 60616, United States

Location status: Recruiting

Location contact

Michael Chaglasian, OD

CONTACT

[email protected]

312-949-7303

About this study

Procedures:

  • Ophthalmic screening:

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

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion / Exclusion Criteria:

  • Age range: 25-70 years
  • For normal subjects:
  • Patient is free of any current or prior ophthalmic pathologies that would potentially cause visual field defects: e.g. retina pathology, glaucoma, cataracts, keratoconus
  • No ocular surgery other than cataract surgery within 6 months prior to the study visit
  • For glaucoma subjects:
  • Patient has a diagnosis of primary open-angle glaucoma
  • Patient is free of any other current or prior ophthalmic pathologies that would potentially cause visual field defects.
  • No other ocular surgery other than glaucoma or cataract surgery within 6 months prior to the study visit
  • No IOP lower than 10 mm/Hg or higher than 30 mm/Hg
  • Refractive Error:
  • Sphere = up to -6.00 D to and up +3.00
  • Cylinder = up to -3.00 is common
  • No past refractive eye surgery
  • No Multifocal or phakic (ICLs) IOL; no multifocal CLs
  • One eligible eye
  • Ability to sit for standard VF bowl exam. Ability to wear VR perimetry headset device.

Treatment and study plan

Perimetric test

Diagnostic 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.

Primary outcomes

  1. Visual field perimetry light sensitivity

    Time frame: 1 day

    Localized differential light sensitivity threshold measured in decibels (dB)

  2. Visual field perimetry foveal sensitivity

    Time frame: 1 day

    Foveal threshold in decibels (dB)

  3. Visual field perimetry test duration

    Time frame: 1 day

    Test duration measured in minutes

Secondary outcomes

  1. Optical Coherence Tomography (OCT)

    Time frame: 1 day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Chaglasian, OD

CONTACT

[email protected]

312-949-7303

Sponsors and collaborators

Lead sponsor

Envision Health Technologies, Inc.

Industry

Collaborators

  • Illinois College of Optometry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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