NCT06549010 Perimetric Testing With Virtual Reality
| NCT ID | NCT06549010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Envision Health Technologies, Inc. |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2024-09 |
Trial Parameters
Eligibility Fast-Check
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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.
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 he