Object Finder for a Retinal Prosthesis
Phase: NA
Conditions: Retinitis Pigmentosa
Sponsor: Minnesota HealthSolutions

Title: Object Finder for a Retinal Prosthesis
NCT# NCT04319809
Date: 10/26/2018

 
 
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Date: 10/26/18____________________    
Principal Investigator: __ Gislin Dagnelie, Ph.D _______________ 
Application Number: _IRB00045074__________ 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
 Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
 When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
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1. 
Abstract 
 
In outer retinal degeneration, such as retinitis pigmentosa (RP), the photoreceptors and their supporting 
retinal pigment epithelium are gradually damaged and destroyed. In RP (incidence 1:4000) legal blindness 
is reached after 25 years. In many RP patients over sixty years of age, rudimentary vision with only gross 
movement or bright light perception remains, with little or no appreciable peripheral vision. Eventually, 
even light perception may recede. Currently, there is no treatment that stops or reverses the loss of 
photoreceptors in retinitis pigmentosa. 
 
The Argus II Retinal Stimulation System developed by Second Sight is a second generation system 
following the first generation Argus 16. The main differences are that the Argus II provides more 
independent channels for stimulation and that the Argus II Implant antenna and electronics are attached to 
the outside of the eye. Like the Argus 16 System, the Argus II system comprises three sub-system 
components: the internal Implant, the external Video Processing Unit (VPU) and Glasses, and the 
supporting Clinical Fitting System. The critical steps leading to the present application are provided below. 
The device was approved by the FDA in February 2013. 
 
Patients being implanted with the Argus II at JHU will be invited to join the FDA-mandated, SSMP-
sponsored post-approval study (PAS; NA_00087968). The FDA and SSMP have authorized participating 
centers to supplement the FDA protocol with their own ancillary research protocols aimed at improved 
understanding of the Argus II and the potential benefits obtained by implantees, who choose to enroll in the 
PAS (NA_00087968) and ancillary studies. 
 
In this ancillary study we are asking Argus II users to perform visual activities under different experimental 
conditions, created by modifying either the settings on the VPU or the imagery provided to the VPU. 
 
In an amendment (July 2017) we are inviting sighted individuals to perform experiments similar to those of 
the Argus II users, viewing simulated prosthetic imagery in a video headset. 
 
2. 
Objectives  
The objective of this study is to supplement the FDA-mandated post-approval study (PAS; 
NA_00087968) with additional functional tests and image manipulations that will help us gain a 
better understanding of Argus II use, and potential benefits for the implantees.  We will be 
presenting the same visual information (in simulated form to sighted individuals, to compare their 
performance to that of Argus II users. 

 
 
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3. 
Background 
The Argus II System was developed to provide electrical stimulation of the retina to induce visual 
perception in blind individuals with retinitis pigmentosa. The Argus II System was extensively 
studied in 30 clinical trial subjects who met this indication for use. Subjects were implanted 
between June 2007 and August 2009. As of November 2012, all subjects had been implanted for 
more than 3 years (with exception of one subject whose device was explanted after 14 months), and 
half of the subjects were followed for over 4 years. Collectively these subjects have been implanted 
(as of November 2012) for a total of over 125 implant-years. Data collected from this trial through 
March 2012 were reported to the FDA in a Humanitarian Device Exemption (HDE) application. 
The Argus II device was granted HDE status by the FDA in Feb 2013. 
 
4. 
Study Procedures 
In addition to the outlined testing in the post-approval study (PAS; NA_00087968) participants who 
have previously been implanted with an Argus II will be asked to practice specific tasks using their 
Argus II retinal prosthesis system, and perform multiple other functional tests to gain better 
understanding of their use of the device and  potential benefits for future implantees.  These practice 
tasks and tests may be carried out in the laboratory, at Johns Hopkins Hospital (JHH), at 
participant’s home or in the participant’s community. Typical examples include object localization 
and manipulation, interaction with stationary or moving individuals and obstacles, wayfinding in 
familiar and unfamiliar settings, and self-care.  The imagery provided to implantees may be filtered 
or enhanced with the objective to improve the understanding by the prosthesis wearer.  Two specific 
changes made to the imagery will be the use of a thermal camera that enhances human bodies and 
warm objects in the image, and the use of a distance-filtering mechanism that allows us to reduce 
image clutter by suppressing information coming from closer or farther away than the user’s range 
of interest. 
In order to test the performance of these systems in realistic situations it is important that they are 
tested in environments where other people are present, such as public spaces around the East 
Baltimore campus.  This raises the issue of video recordings, needed for post-hoc analysis of the 
study participant's interaction with the environment, in terms of correct detection and identification 
of events, but also of timing, e.g., how long it takes a subject to respond to a person passing by, or 
to a potential collision while walking.  In order to avoid inadvertent disclosure of JHM patients 
through such recordings we propose the following measures: 
- 
All video recordings made in JHH areas accessible to patients will avoid recording faces by 
lowering the camera angle 
- 
Any videos that inadvertently do capture identifiable 3rd persons will be promptly analyzed for 
participants' performance data, and destroyed 
- 
Any videos that will be saved for later analysis will be stored on a server that is not network 
connected 
- 
Videos to be shown at scientific gatherings will be carefully selected so no identifiable features 
of 3rd persons are shown 
We will recruit a small cohort of sighted individuals and ask them to perform the same experiments 
as the Argus II users, albeit with simulated rather than real prosthetic vision. 
All participants will be asked to agree to having their tests audio and/or video recorded. 
 
5. 
Inclusion/Exclusion Criteria 
Only those enrolled in the Argus II post-approval study(PAS; NA_00087968) or other interested 
post FDA-approval Argus II retinal implantees or the Argus II Retinal Implant System feasibility 
study (NA_00008133) will be enrolled in this study.  In the sighted comparison group we will enroll 
adults with normal vision who are in good general health.  JHU undergraduates and employees may 
be included. 

 
 
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6. 
Drugs/ Substances/ Devices 
 
ARGUS II SYSTEM DESCRIPTION: 
The Argus II Retinal Prosthesis System consists of the following main parts: 
• 
Argus II Retinal Prosthesis (referred to as the “Implant”) 
• 
Argus II Video Processing Unit (referred to as the “VPU”) 
• 
Argus II Glasses 
How Does the Argus II System Work? 
Patients will have the Argus II Retinal Prosthesis implanted in and around their eyeball. To turn on and 
use the implant, patients need to wear the glasses and VPU.  
When patients are using the system, a miniature video camera on the glasses captures images in real time. 
The glasses send these images to the VPU.  The VPU converts these video images into electrical signals 
and send them back to the glasses. The coil on the glasses sends the signals wirelessly to the implant. The 
implant then sends out small pulses of electricity to the retina in the patient's eye. These pulses stimulate 
their surviving secondary cells in the retina.  The retina sends the nerve signals along the optic nerve to the 
brain, and the prosthesis wearer perceives these pulses as patterns of light. Over time, they may learn how 
to interpret these visual patterns as objects and shapes.  
Argus II Retinal Prosthesis System(Implant) 
The implant consists of four parts: (1) the electronics case, (2) the implant coil, (3) the electrode array, and 
(4) the scleral band.  
 Only the electrode array goes inside the eye. The electronics case, the implant coil and the scleral band sit 
on the outside of the eye. The scleral band wraps around patient's eye and holds the implant in place.  The 
conjunctiva, a thin layer of tissue that covers the white part of the eye also covers the parts of the implant 
that sit on the outside of the eye.  
A ribbon cable connects the electronics package to the electrode array. This cable enters patient's eye 
through an incision made during surgery.  At the end of cable is the electrode array. The electrode array is 
fastened over the surface of the retina with a retinal tack. 
The electrode array provides electrical stimulation to patient's retina. It has 60 electrodes arranged in a 
rectangular grid.  Fifty-five of these electrodes are turned on at the time of implant. Up to 5 of the 
remaining electrodes may be functional and could be turned on to replace an electrode that is not working.  
Video Processing Unit (VPU) – External Equipment 
The VPU allows wearers to turn stimulation on and off.  Using the buttons on the VPU, they can change 
the stimulation program to suit their current environment.  
The VPU keeps track of when wearers turn it on and off, and it keeps a record of how well their implant 
and VPU are functioning.  The VPU also records when there is a disruption in the wireless link between 
the implant and glasses.  The clinician can check all of this information when the wearer visits the clinic. 
Glasses– External Equipment 
The glasses have a miniature video camera in the bridge above the nose.  The glasses also have a coil on 
one of the earpieces.  The coil sends power to the implant and communicates wirelessly with it. The glasses 
connect to the VPU with a cable. Patient must wear both the VPU and glasses for the system to work.  

 
 
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Equipment for simulations in sighted individuals 
Instead of the Argus II glasses and implant, sighted volunteers will be fitted with a pair of video goggles 
and an external graphics processor that will generate video imagery closely resembling the prosthetic 
iimagery perceived by the Argus II users.  The same image capture systems used to capture the scene for 
the Argus II users will be used in simulations with sighted individuals. 
 
7. 
Study Statistics 
NA 
 
8. 
Risks 
Similar to the Post-Approval Study (NA_00087968) and Argus II retinal Implant Feasibility Study 
(NA_00008133) , all practice and testing will take place under immediate supervision of study team 
members.  Moreover, these activities will be no different from those undertaken by blind and 
partially sighted individuals.  Therefore, the study will not add appreciable risk to that of being 
blind and having a retinal prosthesis system. 
No additional risks will exist for sighted participants, who will also be closely supervised. 
9. 
Benefits 
The direct benefits of participation in this study may include greater proficiency in the operation 
and use of the Argus II retinal prosthesis system.  There will be no benefit to sighted participants. 
 
10. 
Payment and Remuneration 
Sighted participants will receive a modest remuneration ($10/hr), while Argus II users will not be 
paid for this study. Travel reimbursement/lunch vouchers will be offered to all participants. 
 
11. 
Costs 
Tests will be at no cost to the participants. No additional costs anticipated.