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

June 3, 2022 updated by: M. Reza Razeghinejad MD, Wills Eye

How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Diagnostic test: 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.
Other Names:
  • SAP HFA
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.
Other Names:
  • vFA
Experimental: 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.
Diagnostic test: 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.
Other Names:
  • SAP HFA
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.
Other Names:
  • vFA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Retinal Sensitivity From Two Machines
Time Frame: three hours
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)
Time Frame: three hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
Time Frame: three hours
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal 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 inferior (lower) nasal portion of the visual field, between two testing machines.
three hours
Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
Time Frame: three hours
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the 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 in the superior hemifield, between two testing machines.
three hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wills Eye

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Olleyes, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: M Reza Razeghinejad, MD, Wills Eye

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB Control #18-768E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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