Actively Recruiting

Phase Not Applicable
Age: 25Years - 70Years
All Genders
Healthy Volunteers
NCT06549010

Perimetric Testing With Virtual Reality

Led by Envision Health Technologies, Inc. · Updated on 2024-08-12

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

E

Envision Health Technologies, Inc.

Lead Sponsor

I

Illinois College of Optometry

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Perimetric Testing With Virtual Reality

Who Can Participate

Age: 25Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 25 and 70 years
  • For healthy subjects: no current or past eye diseases causing visual field defects such as retina disease, glaucoma, cataracts, or keratoconus
  • No eye surgery other than cataract surgery within 6 months before the study visit for healthy subjects
  • For glaucoma patients: diagnosed with primary open-angle glaucoma
  • No other eye diseases causing visual field defects for glaucoma patients
  • No eye surgery other than glaucoma or cataract surgery within 6 months before the study visit for glaucoma patients
  • Intraocular pressure between 10 and 30 mm/Hg for glaucoma patients
  • Refractive error sphere between -6.00 and +3.00 and cylinder up to -3.00
  • No past refractive eye surgery
  • No multifocal or phakic intraocular lenses or multifocal contact lenses
  • Only one eligible eye
  • Ability to sit for standard visual field exam and wear the VR headset
Not Eligible

You will not qualify if you...

  • Presence of any ophthalmic pathology causing visual field defects (for healthy subjects)
  • Eye surgery other than cataract or glaucoma surgery within 6 months prior to study visit
  • Intraocular pressure lower than 10 mm/Hg or higher than 30 mm/Hg (for glaucoma patients)
  • Past refractive eye surgery
  • Use of multifocal or phakic intraocular lenses or multifocal contact lenses
  • Inability to sit for the visual field exam or wear the VR headset

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Illinois College of Optometry / Illinois Eye Institute

Chicago, Illinois, United States, 60616

Actively Recruiting

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Research Team

M

Michael Chaglasian, OD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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