Perimetric Testing With Virtual Reality

NCT06549010 | Recruiting FDA Device

• 1 other identifier: ENV1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Glaucoma; Perimetric test; virtual reality

Outcome Measures

Primary Outcomes (3)

• Visual field perimetry light sensitivity

  Localized differential light sensitivity threshold measured in decibels (dB)

  1 day

• Visual field perimetry foveal sensitivity

  Foveal threshold in decibels (dB)

  1 day

• Visual field perimetry test duration

  Test duration measured in minutes

  1 day

Secondary Outcomes (1)

• Optical Coherence Tomography (OCT)

  1 day

Study Arms (2)

Healthy subjects

OTHER

30 healthy subjects

Diagnostic Test: Perimetric test

Glaucoma subjects

OTHER

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

Diagnostic Test: Perimetric test

Interventions

Perimetric test DIAGNOSTIC_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.

Glaucoma subjects; Healthy subjects

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Envision Health Technologies, Inc.: lead
• Illinois College of Optometry: collaborator

Study Sites (1)

Illinois College of Optometry / Illinois Eye Institute

Chicago, Illinois, 60616, United States

RECRUITING

Related Publications (4)

• Montesano G, Bryan SR, Crabb DP, Fogagnolo P, Oddone F, McKendrick AM, Turpin A, Lanzetta P, Perdicchi A, Johnson CA, Garway-Heath DF, Brusini P, Rossetti LM. A Comparison between the Compass Fundus Perimeter and the Humphrey Field Analyzer. Ophthalmology. 2019 Feb;126(2):242-251. doi: 10.1016/j.ophtha.2018.08.010. Epub 2018 Aug 14.

  PMID: 30114416 BACKGROUND

• Marin-Franch I, Turpin A, Artes PH, Chong LX, McKendrick AM, Alawa KA, Wall M. The Open Perimetry Initiative: A framework for cross-platform development for the new generation of portable perimeters. J Vis. 2022 Apr 6;22(5):1. doi: 10.1167/jov.22.5.1.

  PMID: 35385053 BACKGROUND

• Marin-Franch I, Swanson WH. The visualFields package: a tool for analysis and visualization of visual fields. J Vis. 2013 Mar 14;13(4):10. doi: 10.1167/13.4.10.

  PMID: 23492926 BACKGROUND

• Bradley C, Ahmed IIK, Samuelson TW, Chaglasian M, Barnebey H, Radcliffe N, Bacharach J. Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment. Transl Vis Sci Technol. 2024 Mar 1;13(3):10. doi: 10.1167/tvst.13.3.10.

  PMID: 38488433 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Michael Chaglasian, OD

  Illinois College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Chaglasian, OD

CONTACT

312-949-7303; mchaglas@ico.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 30 healthy subjects 30 glaucoma subjects

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 12, 2024
• Study Start: July 3, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will submitted for publication in a medical journal, within 3-6 months of completion of the data analysis of the monitored and locked database.
• Access Criteria: The trial results will be published in an open-access medical journal.

Locations

US (1)