Recruiting

Virtual Reality

Sponsor:

Envision Health Technologies, Inc.

Code:

NCT06549010

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

Interventions

Perimetric test

Study Details

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.

Conditions

Glaucoma

Study ID

NCT06549010

Start date

Jul 3, 2024

Status verified date

Aug, 2024

Completion date

Oct, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Healthy subjects

30 healthy subjects

other: Glaucoma subjects

30 glaucoma patients, 10 mild, 10 moderate, 10 severe

Interventions

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 measure

  • Visual field perimetry light sensitivity [ Time Frame: 1 day ]
  • Visual field perimetry foveal sensitivity [ Time Frame: 1 day ]
  • Visual field perimetry test duration [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Michael Chaglasian, OD

312-949-7303mchaglas@ico.edu

Locations

Illinois College of Optometry / Illinois Eye Institute

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Michael Chaglasian, OD

312-949-7303mchaglas@ico.edu

More Information

Sponsor

Envision Health Technologies, Inc.

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Keywords

  • Glaucoma
  • Perimetric test
  • virtual reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Envision Health Technologies, Inc. on 2024-08-12.