visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry

NCT03804684 | Completed Results FDA Device

• 1 other identifier: IRB Control #18-768E
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).

Conditions

Glaucoma, Open-Angle

Keywords

open angle glaucoma; visual field; Standard Automatic Perimetry

Outcome Measures

Primary Outcomes (2)

• Mean Retinal Sensitivity From Two Machines

  Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.

  three hours

• Global Correlation (Agreement Between Two Machines in the Overall Visual Field)

  Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.

  three hours

Secondary Outcomes (2)

• Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)

  three hours

• Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field

  three hours

Study Arms (2)

Healthy Controls

EXPERIMENTAL

Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.

Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer

Mild and Moderate Glaucoma

EXPERIMENTAL

Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field.

Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer

Interventions

Standard Automatic Perimetry Humphrey Field Analyzer DIAGNOSTIC_TEST

Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.

Also known as: SAP HFA

Healthy Controls; Mild and Moderate Glaucoma

visuALL Field Analyzer DIAGNOSTIC_TEST

visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.

Also known as: vFA

Healthy Controls; Mild and Moderate Glaucoma

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 21 to 80 years
• Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
• mild glaucoma subjects with less than -6 mean deviation
• moderate glaucoma subjects with -6 to -12 mean deviation

You may not qualify if:

• spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
• Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
• Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
• SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
• Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
• History of systemic condition known to affect visual function
• History of medication known to affect visual function

Sponsors & Collaborators

• Wills Eye: lead
• Olleyes, Inc.: collaborator

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.

  PMID: 32941320 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Limitations and Caveats

Disadvantages of VisuALL are similar to standard automated perimetry. They rely on patient cooperation and concentration during visual field examination. In addition, the system does not include follow-up analysis. The head-mounted device may not be preferred by subjects with claustrophobic tendencies.

Results Point of Contact

• Title: M. Reza Razeghinejad, MD
• Organization: Wills Eye Hospital

reza@willseye.org

12159283197

Study Officials

• M Reza Razeghinejad, MD

  Wills Eye

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 8, 2019
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: June 29, 2022
• Results First Posted: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)