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?
Phase: NA
Conditions: Glaucoma, Open-Angle
Sponsor: Wills Eye

840 Walnut Street 
Philadelphia, PA 19107 
215-928-3000 
1-877-AT-WILLS 
www.willseye.org 
 
                                                                                                                     
 
 
 
 
 
 
 
 
 
visuALL Validation Study 1.2 
Principal Investigator: M. Reza Razeghinejad, MD 
 
 
NCT03804684 
IRB# 18-768E 
 
 
Study Protocol 
November 6, 2018 

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visuALL Validation Study 1.2 
 
Protocol Number 
001 
Principal Investigator (PI) 
M. Reza Razeghinejad MD 
PI email 
mrazeghi@willseye.org 
Coordinating Center 
Wills Eye Hospital; 840 Walnut Street, Philadelphia, PA 19107 
Protocol Version 
1.2 
Date 
October 1, 2018; rev. November 6, 2018 
Protocol Authors 
L. Jay Katz, MD 
Dr. Alberto Gonzalez Garcia 
Liaison/Olleyes  
Dr. Alberto Gonzalez Garcia 
gonzalezao@olleyes.com 
Sponsor 
Olleyes, Inc. 
11 Hillcrest Dr, Randolph 
NJ 07869 
973-567-8068 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Objective 
To determine age-adjusted reference values of the visuALL Field Analyzer 
(vFA), to assess the repeatability for each parameter and correlate them 
with a Standard Automatic Perimetry (SAP) parameters. 
Study Rationale 
Standard Automatic Perimetry (SAP) is the gold standard test for the 
evaluation of different diseases of the visual pathway like glaucoma. Its 
main goal is to measure the differential light sensitivity at several 
locations of the central field of vision. Nevertheless, the accuracy of the 
current device is limited by several factors like the inherent inconsistency 
of the psychophysical test, stressful examinations and frequency of 
testing among others.1,2 
Several devices have been developed since the advent of the Octopus 
Perimeter3-5 and the Humphrey Field Analyzer (HFA),6,7 in an effort to 
improve the early detection glaucoma.8,9 Examples of these visual field 
test variants are implemented using laptops and iPads and virtual reality 
headsets.10-13  
These modalities bring portability but the lack of fixation methods, 
environmental control and hardware standardization may limit its wide 
usage. 
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 the 
evaluation of its correlation with HFA parameters. 
 
Study Design 
visuALL-1 is a cross-sectional observational study. The primary endpoint 
of the study will be at end of the recruitment phase. 
Participants 
A group of healthy subjects and patients with glaucoma; between 21 and 
80 years old will be invited to participate in the study. A total of 50 
healthy eyes and an additional 50 eyes with glaucoma will be recruited 
for this study. 
All subjects will undergo a complete ophthalmologic examination at the 
glaucoma department of Wills Eye Hospital. Each examination will 
include refraction, slit lamp biomicroscopy of the anterior segment, IOP 
measurement, BCVA, visual field and visuALL Field Analyzer (vFA) testing, 
gonioscopy and dilated stereoscopic fundus examination of the retina 
and optic nerve head. Data about family history of glaucoma will also be 
recorded.  

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Study Groups: 
1. Control group: Healthy eyes (n=50) 
2. Glaucoma group: Chronic Open Angle Glaucoma (COAG) eyes 
(n=50) 
- 
30 eyes with mild COAG 
- 
20 eyes with moderate COAG 
The recruitment process of healthy subjects will include a stratification 
based on age as indicated in the table below. 
Age Group (years) 
Eyes 
30 - 39 
10 
40 - 49 
10 
50 - 59 
10 
60 - 69 
10 
70 and more 
10 
 
Individuals of different races will be included but no single ethnic group 
will encompass more than 50%. 15% of gender differences will be 
allowed. 
The clinical study plan will be reviewed and approved by Wills Eye 
Hospital Institutional Review Board (IRB). 
Healthy criteria 
 Normal appearing optic nerve and retina 
 IOP < 19 mmHg. 
 Normal SAP results in both eyes. (See SAP criteria) 
COAG criteria 
 Glaucomatous appearing optic nerve and/or retina (i.e. increased 
cup to disc area ratio, rim thinning or RNFL defects indicative of 
glaucoma) 
 Abnormal SAP results in the study eye. (See SAP criteria) 
Exclusion criteria 
1. 
A spherical refraction outside ± 3.0 D and cylinder correction 
outside 2.0 D. 
2. 
Unreliable SAP (false positives, fixation losses and false negatives 
>25% and/or observable testing artifacts).  
3. 
Unreliable vFA (>25% false positive, excessive fixation losses) 
4. 
SAP abnormality with a pattern of loss which is consistent with a 
neurologic and/or other ocular diseases than glaucoma. 

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5. 
Intraocular surgery in the study eye (except non-complicated 
cataract or refractive surgery performed more than 6 months 
before enrollment and without posterior capsule opacification). 
6. 
History of systemic condition known to affect visual function. 
7. 
History of medication known to affect visual function. 
Instrumentation 
1. 
Refraction (autorefractor)  
2. 
Tonometry (Goldmann) 
3. 
SAP Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive 
Threshold Algorithm (SITA) Standard Strategy (Carl Zeiss Meditec, 
Inc. Dublin, CA) (single session). 
4. 
visuALL Pro (Olleyes, Inc. Randolph, NJ) (single session).  
Within Normal 
Limits SAP criteria 
Pattern Standard Deviation significant within 95% normal limits, 
Glaucoma Hemifield test within normal limits, and no other pattern of 
loss which is consistent with a neurologic and/or ocular disease. 
vFA reliability 
criteria 
False positives, fixation losses and false negatives >25% and/or 
observable testing artifacts 
vFA Description 
 vFA Pro will be used for this validation study. The visuALL system is 
composed of two main parts - the hardware and the software. 
The hardware includes three main components: A Head Mounted Device 
(HMD) also known as Virtual Reality (VR) headset, a Laptop and a 
Bluetooth connected handpiece.  
The HMD is powered by FOVE (Fove, Inc. Tokyo, Japan). This HMD weight 
520g and includes a Wide Quad High Definition Organic Light Emitted 
Diode (WQHD OLED) display with a resolution of 2560x1440 pixels with a 
refresh rate pf 70Hz. The display is divided in two halves (one for each 
eye) with a resultant resolution of 1280x1440 pixels on each half. The 
display measures 125.4 x 70.56 mm and it is placed at a distance to 
subtend a field of view (FOV) up to 100 degrees.  
The HMD includes several tracking systems, inertial measurement units 
(IMUs) consisting of gyroscopes and accelerometers, in addition to 
infrared-based (IR) position tracking with two arrays of 6 IR sensors. 
The HMD uses 2 eye-tracking system including infrared cameras with a 
frame rate of 120fps. The eye-tracking system has a resolution of less 
than 1 degree.  
The main PC components are a graphic processing units (GPU) NVIDIA 
GeForce GTX 970, a central processing unit (CPU) Intel Core i7 7th Gen 
7820HK (2.90 GHz), random access memory (RAM) of 32GB, a hard disk 

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drive (HDD) of 1 TB and 3 main interfaces: one High Definition Media 
Interface (HDMI), one Universal Serial Bus (USB) 3.0 and two USB 2.0. 
The PC runs and Operating System (OS) WINDOWS 10 64-bit. The PC 
networking protocols are Killer Ethernet E2400 10/100/1000 Gigabit 
Ethernet LAN (RJ-45 port), Wi-Fi Dual-Band (WLAN) 2.4GHz and 5GHz 
and Bluetooth 4.1 
The visuALL software includes three main testing protocols.  
Parameters 
SupraT 
NormalT 
FlickerT 
Range (degrees) 
24 
24 
24 
Background Illumination (cd/m2) 
10 
10 
50 
Stimulus Locations 
54 
54 
54 
Stimulus Size (degrees) 
0.43 
0.43 
5 
Stimulus Duration (ms) 
150 
150 
Up to 200 
Stimulus Intensity (cd s/m2) 
100 
Variable 
50 
Inter-stimulus Time (ms) 
Random 
Random 
Random 
Fixation Control 
Eye tracking with dynamic stimulation-grid 
adjustment within a threshold area, 
otherwise paused. Blinking control 
  
vFA Outcome 
Measurements 
 Retinal sensitivity at each location 
 Mean retinal sensitivity at each quadrant 
 Mean retinal sensitivity at each hemifield 
 Mean retinal sensitivity 
Analyses 
 
1. Descriptive statistics and demographics 
2. References values 
3. Reliability indexes for HFA and vFA variables 
4. Agreement between HFA and vFA variables 
References 
1. Heijl A, Lindgren A, Lindgren G. Test-retest variability in 
glaucomatous visual fields. Am J Ophthalmol. 1989;108:130-135. 
2. Russell RA, Crabb DP, Malik R, Garway-Heath DF. The relationship 
between variability and sensitivity in large-scale longitudinal visual 
field data. Invest Ophthalmol Vis Sci. 2012;53:5985-5990. 
3. Spahr J, Fankhauser F, Bebié H. Advances in the automation of 
perimetry. Klin Monbl Augenheilkd. 1976;168:84-6. 
4. Spahr J, Fankhauser F, Jenni A, Bebie H. Practical experiences with 
the Octopus automatic perimeter. Klin Monbl Augenheilkd. 
1978;172:470-7. 
5. Portney GL, Krohn MA. Automated perimetry: background, 
instruments and methods. Surv Ophthalmol. 1978;22:271-8. 

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This material is the property of Olleyes, Inc. Do not disclose or use except as authorized in writing by the study sponsor 
6. Beck RW, Bergstrom TJ, Lichter PR. A clinical comparison of visual 
field testing with a new automated perimeter, the Humphrey Field 
Analyzer, and the Goldmann perimeter. Ophthalmology. 
1985;92:77-82. 
7. Brenton RS, Phelps CD. The normal visual field on the Humphrey 
field analyzer. Ophthalmologica. 1986;193:56-74. 
8. Bosworth CF, Sample PA, Johnson CA, Weinreb RN. Cur- rent 
practice with standard automated perimetry. Semin Ophthalmol 
2000;15:172–181. 
9. Delgado MF, Nguyen NTA, Cox TA et al. Automated perimetry: a 
report by the American Academy of Ophthalmology. 
Ophthalmology 2002;12:2362–2374. 
10. Wu Z, Guymer RH, Jung CJ, et al. Measurement of retinal sensitivity 
on tablet devices in agerelated macular degeneration. Trans Vis Sci 
Tech. 2015;4:13. 
11. Tahir HJ, Murray IJ, Parry NRA, Aslam TM. Optimization and 
Assessment of Three Modern Touch Screen Tablet Computers for 
Clinical Vision Testing. PLoS ONE 2014;9: e95074. 
12. Vingrys AJ, Healey JK, Liew S, et al. Validation of a tablet as a 
tangent perimeter. Trans Vis Sci Tech. 2016;5:3. 
13. Prea SM, Yu Kong YXG, Mehta A, He M, Crowston JG, Gupta V, 
Martin KR, Vingrys AJ. Six-month Longitudinal Comparison of a 
Portable Tablet Perimeter With the Humphrey Field Analyzer. Am J 
Ophthalmol 2018;190:9–16. 
Proposed Due Date 
for Analysis of 
Primary End Point 
Data: 
February 2019 
Planned 
Publications & 
Abstract 
Submissions: 
The Study will plan to submit abstracts for 2019 ARVO. Subsequently two 
manuscripts will be written and submitted to Journal of Glaucoma and 
Ophthalmology.