NCT06549010 · Envision Health Technologies, Inc.
Perimetric Testing With Virtual Reality
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Perimetric 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 outcome measures
Visual field perimetry light sensitivity
Time frame: 1 day
Localized differential light sensitivity threshold measured in decibels (dB)
Visual field perimetry foveal sensitivity
Time frame: 1 day
Foveal threshold in decibels (dB)
Visual field perimetry test duration
Time frame: 1 day
Test duration measured in minutes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Collaborators
Illinois College of Optometry
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2024 · Source of record for eligibility and locations