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

Glaucoma, Open-Angle Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804684
• Other study ID #: IRB Control #18-768E
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: June 2022
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Olleyes, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal 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 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
Secondary	Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield 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 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