RecruitingRecruiting
Perimetric Testing With Virtual Reality
NCT06549010 · Envision Health Technologies, Inc.
In plain English
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Official title
A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.
About this study
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.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-03
Estimated completion: 2024-10
Last updated: 2024-08-12
Interventions
Diagnostic Test: Perimetric test
Primary outcomes
- • Visual field perimetry light sensitivity (1 day)
- • Visual field perimetry foveal sensitivity (1 day)
- • Visual field perimetry test duration (1 day)
Sponsor
Envision Health Technologies, Inc. · industry
With: Illinois College of Optometry
Contacts & investigators
ContactMichael Chaglasian, OD · contact · mchaglas@ico.edu · 312-949-7303
InvestigatorMichael Chaglasian, OD · principal_investigator, Illinois College of Optometry
All locations (1)
Illinois College of Optometry / Illinois Eye InstituteRecruiting
Chicago, Illinois, United States