Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549010
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Perimetric Testing With Virtual Reality
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None