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

NCT ID: NCT03804684

Last Updated: 2022-06-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2020-10-20

Brief Summary

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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).

Detailed Description

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Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.

Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.

The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Controls

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.

Group Type EXPERIMENTAL

Standard Automatic Perimetry Humphrey Field Analyzer

Intervention Type 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.

visuALL Field Analyzer

Intervention Type 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.

Mild and Moderate Glaucoma

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.

Group Type EXPERIMENTAL

Standard Automatic Perimetry Humphrey Field Analyzer

Intervention Type 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.

visuALL Field Analyzer

Intervention Type 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.

Interventions

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Standard Automatic Perimetry Humphrey Field Analyzer

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.

Intervention Type DIAGNOSTIC_TEST

visuALL Field Analyzer

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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SAP HFA vFA

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Olleyes, Inc.

INDUSTRY

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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M. Reza Razeghinejad MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M Reza Razeghinejad, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye

Locations

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Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 32941320 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB Control #18-768E

Identifier Type: -

Identifier Source: org_study_id

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