Illinois College of Optometry / Illinois Eye Institute
Chicago, Illinois, 60616, United States
Location status: Recruiting
NCT Number: NCT06549010
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.
Interested in participating?
Request Info25 year–70 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60616, United States
Location status: Recruiting
Procedures:
(a) Visual acuity, slit lamp exam, rebound tonometry (all subjects)
(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.
(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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion / Exclusion Criteria:
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.
Time frame: 1 day
Localized differential light sensitivity threshold measured in decibels (dB)
Time frame: 1 day
Foveal threshold in decibels (dB)
Time frame: 1 day
Test duration measured in minutes
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.
Contact information is provided by the study sponsor or research team.
Envision Health Technologies, Inc.
Industry
A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.
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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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