Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001)
Phase: NA
Conditions: Anterior Segment of Eye
Sponsor: Lightfield Medical

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN
Official Title:
Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic
Camera Model Vscan001)
NCT Number:
Pending Assignment
Document Date:
May 22, 2023
Sponsor:
Lightfield Medical
Protocol Number:
001

Sponsor: Lightfield Medical
3400 W Bde Maka Ska Parkway, Mpls, MN 55416
763-438-8697
John Berestka, MD and Jan Bonel, PhD
Monitor: Same
Medical Expert: John S. Berestka, MD
8501 Golden Valley Road, Suite 100, Golden Valley, MN 55427
763-438-8697
Investigators: Principal Investigator
John S. Berestka, MD
763-438-8697
Associate Investigator
Chris B. Kruthoff, OD
641-330-3572
Study Coordinator
Helen Kim, COA
612-812-5411
Technical Officer/Device Trainer
Matthew L. Berestka
612-383-5553
Research Assistant
Joshua Schlueter, COA
763-567-0703
Research Assistant
Mimi Oenthenthapanya, COMT
612-419-6249
Research Assistant/Software Specialist
Brandon Lu
763-383-4186

All staff can be reached at:
Northwest Eye
8501 Golden Valley Road, Golden Valley, MN 55427
763-416-7600
Study Product: Lightfield Medical Model Vscan001
Protocol Number: 001
Initial version date: 5/22/2023
Study Protocol
1. Introduction
Background
The primary instrument used in eye examinations—the ophthalmic slit lamp—has not changed in over
75 years. The main improvement has been the transition from an incandescent light source to an LED
light source. Ophthalmic devices for imaging the back of the eye have been in widespread use for over
two decades. Ophthalmic devices to image the front of the eye such as a conventional slit lamp
camera, on the other hand, are rarely used because they can only be done by a highly trained
physician/optometrist or specialized ophthalmic photographer. Other problems make imaging the front
of the eye with a conventional slit lamp camera difficult. Specifically, only a small portion of the exam
can be recorded, focus is very difficult, lighting and aperture settings are challenging, and glare artifacts
and resolution limits hinder their use.
Lightfield Medical has developed an automated slit lamp using high speed photography and high speed
liquid lenses that can capture all of the typical views obtained in a slit lamp exam. The exam can be
performed within minutes and uses an LED light source that is no brighter than a conventional slit lamp.
High quality images have been obtained on the inventor’s own eyes. The device is capable of capturing
slit-illuminated eye images from multiple angles and lighting scenarios. Variables such as the optimal
number of image views, image resolution, and viewing angles still need to be determined.
Investigational or Study Product
The Lightfield Medical Automated Slit Lamp Camera model Vscan001 is a semi-portable device that
looks similar to an ophthalmic slit lamp or other ophthalmic imaging devices such as a the corneal

topographer or ocular coherence tomographer. It consists of a chin and head rest to stabilize the
patient’s head and a joy-stick mounted base with a similar design to a normal slit lamp. Instead of the
usual slit-lamp eyepieces, a high speed 5 megapixel main camera sensor is positioned in front of the
patient’s eye. A liquid lens capable of focusing every 4 milliseconds is optically coupled to this sensor to
control focus in the z-axis of the eye. A wide angle 5 megapixel auxiliary camera is positioned below
this main camera to get wide angle views of the eye and to assist with focusing. An LED-based
projector is used to move a slit image across the eye in the x-axis. This slit image is focused through a
high speed liquid lens which is synced to the camera’s liquid lens so a well-focused light slit on the
cornea or lens can be imaged. The slit projector is mounted on a rotating base with a pivot point located
below the patient’s chin (which is, in turn, located directly below the patient’s eye) much like a
conventional slit lamp arm. A microprocessor controls the slit lamp movement across the eye and other
parameters such as slit width and position relative to ocular structures. The operator moves the joystick
to obtain initial focus. The operator also manually swings the slit projector arm in an arc to various
positions (for instance 0, 22 and 45 degrees off center. (Future models will automate this step.) The unit
is coupled to a Windows computer using USB connections. Images will be stored on an encrypted hard
drive as both Raw and JPEG images.
The device meets all of the criteria of the FDA PJZ classification for a slit lamp camera and is
considered FDA Class 2 exempt. It also meets FDA criteria for non-significant risk classification (see
section 5)
Preclinical Data
Successful images have been taken of calibration grids and model eyes. Nomograms have been
established to determine the microprocessor instructions to control the slit projector and the liquid
lenses to focus both the slit image and the camera.
Clinical Data to Date
Clinical data has been obtained on the inventors’ eyes in the development laboratory in the European
Union. The images are sharp and mimic those that can seen during a conventional slit lamp exam. See
example data.
Risks/Benefits
The main risk is the light energy delivered to the eye. The LED-based light energy is similar or less than
a conventional slit lamp examination. The energy output has been tested by Diestia Laboratories and
meets group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy
conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic
Instruments. The FDA uses this ANSI standard to determine if a slit lamp camera is Class 2 exempt,
and this device would qualify. There are no other source of energy introduced into the human body, and
this device would qualify as a non-significant risk device, under FDA guidelines.
The only other risks envisioned would be possible minor soft tissue mechanical injury during the
examination if the patient has trouble putting their chin on the chinrest or their forehead up to the
forehead rest. Much like a conventional slit lamp, there is also a small chance that the illumination arm
could bump into the patient’s nose. These types of minor injuries would be expected to be quite rare
and similar in frequency to those incurred during a conventional slit lamp exam.

The benefit of the device is that it would automate the slit lamp exam and allow it to be delegated to a
technician. The eye exam can be automatically photo-documented for both the patient and the doctor.
Ophthalmologists could review the exam on a computer screen in the room with the patient. Patients
could see their pathology and would be better educated about their condition. Telemedicine would now
be possible in ophthalmology. Underserved populations throughout the world could get eye care
without the presence of an ophthalmologist or optometrist. The only requirements would be a minimally
trained technician and a USB memory stick or internet connection.
Study Objectives
The study aims to determine the feasibility of performing an automated slit lamp exam in a clinical
setting.
Study Design
General Design
Patients will be recruited to be subjects of this automated slit lamp camera feasibility study. Some of the
subjects will have ocular pathology and others will not—the goal of the study is only to determine the
feasibility of automated photo documentation in a wide range of patients. A goal of at least 50 patients
will be studied, with an option to extend the study to 200 patients. Patients can be examined more than
once, particularly if they have pathology that changes over time.
The study will take place in two phases: Optimization/Calibration and General Recruitment
The Optimization/Calibration phase will consist of lengthier examinations (lasting 5-20 minutes) as
various settings (shutter speed, aperture, sensor gain, illumination angles and slit widths) are optimized
before general recruitment starts. Subjects for this phase may be study personnel or clinic employees
who volunteer to also be participants in the study. Study personnel or employees will be under no
obligation to participate. Subjects in this category will have a special informed consent (see ICD). The
ethical considerations of using study personnel or employees as study subjects have been considered,
but their inclusion seems more ethical than making volunteer clinic patients sit through these tedious
optimization exams. The medical risks of participating as study subjects are extremely low, and are
about the same level of medical risk as a regular slit lamp eye examination. There may also be times
when the study personnel will need to recalibrate the instrument and FDA regulations only allow use of
the device on humans under IRB review. Allowing study personnel to quickly calibrate on each other
will be much more advantageous than recruiting a separate patient subject for this purpose. It is
estimated that 5-10 subjects will fall into this category.
The General Recruitment phase of the study will include a much larger number of patients who will be
recruited through Northwest Eye Clinic and its associated clinic, Minnesota Eye Consultants who both
operate under the umbrella of Unifeye Vision Partners. Some patients may be referred from other
surrounding clinics. An email to patients of Northwest Eye Clinic will be sent out. (copy attached). A
separate email will also be sent out to potential referring doctors who work in other eye care practices.
(copy attached)
Primary/Secondary Study Endpoints

This is primarily a feasibility study. The primary endpoint will be the number of patients who can be
successfully imaged compared to the number of patients who could not be successfully imaged. There
are several photographic and illumination settings that can be adjusted on the device. The various
combinations of shutter speed, aperture, sensor gain, and illumination will be used as exploratory
endpoints to come up with the optimal settings for a follow-on study.
Subject Selection and Withdrawal
4.1 Inclusion Criteria
Patients over the age of 18 who have the mobility and ability to rest on the chin and forehead rests will
be eligible to be studied. Patients will be allowed to have multiple examinations if they have changing
pathologies. Most patients will only have one examination.
4.2 Exclusion Criteria
Patients younger than 18, patients physically unable to position at the device, patients with movement
disorders and patients with significant photophobia will be excluded from the study.
4.3 Subject Recruitment and Screening
Patients will be recruited primarily out of the Northwest Eye clinic population. Patients with appropriate
ocular pathology will be made aware of the study and offered to join the study. Some subjects may be
referred in by doctors in other Minneapolis are clinics. No reimbursement will be provided to either
subjects or referring providers. Recruitment will be done through an email to potential patients as well
as a recruitment letter sent out to nearby doctors in other clinics.
4.4 Early Withdrawal of Subjects
Patients will be allowed to withdraw from the study at any time.
5. Investigational Product
5.1 Description
The Vscan001 device is a semiportable device that looks similar to an ophthalmic slit lamp and other
ophthalmic imaging devices such as a corneal topographer of ocular coherence tomographer. It
consists of a chin and head rest to stabilize the patient’s head and then a joy-stick mounted base with a
design similar to a normal slit lamp. Instead of the usual slit-lamp optics, a high speed 5 megapixel
main camera sensor is positioned in front of the patient’s eye. A liquid lens capable of focusing every 4
milliseconds is optically coupled to this sensor to control focus in the z-axis of the eye. A wide angle 5
megapixel auxiliary camera is positioned below this main camera to get wide angle views of the eye
and to assist with focusing. A projector is used to move a slit image across the eye in the x-axis. This is
coupled to a high speed liquid lens that is synced to the camera’s liquid lens so that slit image can be
focused on various eye structures and the image of the slit itself will be in focus on the main camera’s
sensor. The slit projector is mounted on a rotating base, much like a conventional slit lamp arm. A
microprocessor controls the slit lamp movement across the eye, and it also controls other parameters
such as slit width and position relative to ocular structures. The operator will need to move the joystick

to obtain initial focus. The operator will also need to manually swing the slit projector arm to various
positions. (Future models will automate the rotation of the slit projector arm.) The unit will be coupled to
a laptop computer using USB and HDMI connections. During image acquisition, the projected light slit
will move across the the eye and the cameras will take a series of images at different depths. Wide
angle views will also be obtained in various gaze directions. A library of images will be obtained for
each patients. Images will be stored on an encrypted hard drive as both Raw and JPEG images.
The device is considered non-siginficant risk per the FDA guidelines outlined in 21 CFR 812.3(m):
What is a Significant Risk Device Study?
Under 21 CFR 812.3(m), an SR device means an investigational device that:
Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a
subject—NO
Is purported or represented to be for use supporting or sustaining human life and presents a potential
for serious risk to the health, safety, or welfare of a subject—NO
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a potential for serious risk to the health, safety, or
welfare of a subject—NO
or,
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject—NO
B. What is a Nonsignificant Risk Device Study?
An NSR device study is one that does not meet the definition for an SR device study—SATISFIED
The device also qualifies as a Class 2 exempt device. The FDA has a PJZ classification for slit lamp
cameras that establishes whether a device qualifies as 510(k) exempt and this device meets all of the
established criteria:
FDA Title 21, Chapter 1, Subchapter H, Section 886.1120
(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the
eye and the surrounding area.—SATISFIED
(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use
ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of
this chapter subject to the limitations in § 886.9.
PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye
and surrounding area in the general population. PJZ cameras cannot be indicated for any specific
population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in
diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do
not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light
energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for
Ophthalmic Instruments.—SATISFIED, SEE ANSI CERTIFICATION

PJZ cameras are designed for true color or monochrome imaging in visible spectrum of light and
consists of an incoherent light source, image forming lens, aperture, and a sensitive photodetector
array (e.g., a CCD array) in the image plane. PJZ excludes cameras that make use of advanced
imaging technology (e.g., confocal imaging, adaptive optics, two photon imaging, stroboscopic or
scanning illumination). PJZ excludes cameras that feature any special imaging modalities, such as
multispectral imaging, fluorescence, autofluorescence, fluorescein angiography, indocyanine green
(ICG) angiography, etc. PJZ exclude cameras that designed to contact cornea or any other ocular
structure for imaging.—ALL COMPONENTS SATISFIED
The device meets all of the criteria of the FDA PJZ classification for a slit lamp camera and is
considered FDA Class 2 exempt.
The study will also comply with the labeling and record-keeping regulations in FDA Title 21, Chapter 1,
Subchapter H, Section 812.2(b):
An investigation of a device other than a significant risk device, if the device is not a banned device and
the sponsor:
(i) Labels the device in accordance with § 812.5;
(ii) Obtains IRB approval of the investigation after presenting the reviewing IRB with a brief explanation
of why the device is not a significant risk device, and maintains such approval;
(iii) Ensures that each investigator participating in an investigation of the device obtains from each
subject under the investigator's care, informed consent under part 50 and documents it, unless
documentation is waived by an IRB under § 56.109(c).
(iv) Complies with the requirements of § 812.46 with respect to monitoring investigations;
(v) Maintains the records required under § 812.140(b) (4) and (5) and makes the reports required under
§ 812.150(b) (1) through (3) and (5) through (10);
(vi) Ensures that participating investigators maintain the records required by § 812.140(a)(3)(i) and
make the reports required under § 812.150(a) (1), (2), (5), and (7); and
(vii) Complies with the prohibitions in § 812.7 against promotion and other practices.
5.2 Treatment Regimen
Not applicable as no treatment is administered.
5.3 Method for Assigning Subjects to Treatment Groups
Not applicable as no treatment is administered.
5.4 Subject Compliance Monitoring
Subjects will be monitored to see if they can complete the examination.
5.5 Prior and Concomitant Therapy
Not applicable as there is no therapeutic component to this study.

5.6 Packaging, Receiving, Storage, Dispensing and Return
Not applicable except as it regards to the delivery and receiving of the device which is documented in
the device log.
6. Study Procedures
Patients will be recruited to the study as outlined above. Informed consent will be obtained by
explaining the risks and benefits of the study and using the attached informed consent document. Any
research staff with a financial conflict of interest (specifically John S. Berestka and Matthew Berestka)
will not be involved in obtaining informed consent. Subjects will be screened for the study by using the
inclusion criteria and exclusion criteria.
Subjects who meet the screening criteria, who volunteer to participate, and sign the informed consent
document will be brought to a dedicated room and seated at the instrument. They will be positioned
much like they would be for a normal ophthalmic slit lamp exam. The device operator will obtain focus
by moving the joystick until the eye is centered and the two focusing lines are in sync. The device will
be activated and the automated exam will begin. The device operator will move the illumination arm
through five preset positions to capture images from different angles. Subjects will be allowed to abort
the exam just by sitting back and pulling their head back from the device. Images will be captured to an
encrypted hard drive. No treatment effect will be derived from the device, as it is merely taking
photographs.
Patients will typically only have one examination and that will be the extent of their study involvement. A
small number of patients with changing pathology may come back for additional examinations.
Subjects will be evaluated by whether or not they were able to be examined using the Vscan001
medical device.
An exploratory endpoint will be the quality of the photographic images. Various combinations of
aperture, shutter speed, sensor gain, slit characteristics and view angles will be subjectively evaluated
by the study team, but these endpoints will not be evaluated statistically. These exploratory endpoints
will be used to design future studies with the best photographic quality.
No diagnostic or medical decisions will be made or attempted with this technology as it is merely a
photo-documentary technology.
7. Statistical Plan
7.1 Sample Size Determination
This study’s endpoint will be a simple count of subjects able to be examined and those unable to be
examined. The comparison of these to numbers will be expressed as simple percentage of those
subjects able to be examined compared to the total number of subjects in the General Recruitment
(non-calibration) phase. The sample size is an arbitrary choice as no statistical analysis will be
performed. We will enroll between 50 and 200 patients.
7.2 Statistical Methods

A simple proportion of subjects who could complete the imaging process compared to all enrolled
subjects will be computed and expressed as a percentage.
7.3 Subject Population(s) for Analysis
The study population will English-speaking adults over 18 who have at least one eye and meet the
inclusionary and exclusionary criteria. The subjects will demographically correlate with the demographic
criteria of the Northwest Eye patient base which is largely white, elderly and suburban, but still
somewhat ethnically and racially diverse.
8. Safety and Adverse Events
8.1 Definitions
Patients will be monitored for any physical or optical injury to the eye or body.
8.2 Assessment of Safety and Efficacy
Any patient who has sustains an injury by either physical signs or symptoms will be evaluated by an
ophthalmologist or primary care physician who is not part of the study. The ophthalmologist or primary
care physician’s report will be communicated to the principal investigator as soon as it is completed so
a determination of adverse event can be made.
8.3 Recording and Reporting of Adverse Events
Adverse events will be communicated to the IRB within 72 hours. Severe adverse events will be
communicated to the IRB within 24 hours.
The study will comply with FDA Title 21, Chapter 1, Subchapter H, Section 812.46:
(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed
agreement, the investigational plan, the requirements of this part or other applicable FDA regulations,
or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either secure
compliance, or discontinue shipments of the device to the investigator and terminate the investigator's
participation in the investigation. A sponsor shall also require such an investigator to dispose of or
return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.
(b) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any
unanticipated adverse device effect.
(2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable
risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon
as possible. Termination shall occur not later than 5 working days—Lightfield Medical is the sponsor
and will comply with these regulations.
See additional procedures for handling adverse events in section 10 or this protocol
8.4 Unblinding Procedures
No randomization will be used.

8.5 Stopping Rules
The study will be stopped if less than 50% of patients are able to be imaged adequately.
8.6 Medical Monitoring
Injury is not expected, but the imaging will take place in a busy ophthalmic practice where there is
always an ophthalmologist or optometrist present during open hours. Referral for non-ophthalmic
injuries outside of the scope of an eye care provider will be made to a primary care physician.
9. Data Handling and Record Keeping
9.1 Confidentiality
Data will be kept in a locked cabinet in a locked room and on an encrypted hard drive in a
password-protected desktop computer.
9.2 Source Documents
The source documents will be electronic raw and jpeg images stored on an encyrpted hard drive. The
encrypted hard drive will be backed up to an online service.
9.3 Records Retention
All records will be retained until study completion and for an additional 2 years.
10. Study Monitoring, Auditing, and Inspecting
The study will be monitored by the principal investigator, the sponsor and IRB. All study staff will
successful obtain a GCP certification for device studies. Logs of training and staff status will be kept for
audits.
The study will comply with FDA Title 21, Chapter 1, Subchapter H, Section 812.140
(a) Investigator records. A participating investigator shall maintain the following accurate, complete, and
current records relating to the investigator's participation in an investigation:
(1) All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including
required reports.
(2) Records of receipt, use or disposition of a device that relate to:
(i) The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
(ii) The names of all persons who received, used, or disposed of each device.
(iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise
disposed of.
(3) Records of each subject's case history and exposure to the device. Case histories include the case
report forms and supporting data including, for example, signed and dated consent forms and medical
records including, for example, progress notes of the physician, the individual's hospital chart(s), and
the nurses' notes. Such records shall include:

(i) Documents evidencing informed consent and, for any use of a device by the investigator without
informed consent, any written concurrence of a licensed physician and a brief description of the
circumstances justifying the failure to obtain informed consent. The case history for each individual
shall document that informed consent was obtained prior to participation in the study.
(ii) All relevant observations, including records concerning adverse device effects (whether anticipated
or unanticipated), information and data on the condition of each subject upon entering, and during the
course of, the investigation, including information about relevant previous medical history and the
results of all diagnostic tests.
(iii) A record of the exposure of each subject to the investigational device, including the date and time of
each use, and any other therapy.
(4) The protocol, with documents showing the dates of and reasons for each deviation from the
protocol.
(5) Any other records that FDA requires to be maintained by regulation or by specific requirement for a
category of investigations or a particular investigation.
(b) Sponsor records. A sponsor shall maintain the following accurate, complete, and current records
relating to an investigation:
(1) All correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA, including
required reports.
All of the components above will be recorded and logged.
(2) Records of shipment and disposition. Records of shipment shall include the name and address of
the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records
of disposition shall describe the batch number or code marks of any devices returned to the sponsor,
repaired, or disposed of in other ways by the investigator or another person, and the reasons for and
method of disposal.
(3) Signed investigator agreements including the financial disclosure information required to be
collected under § 812.43(c)(5) in accordance with part 54 of this chapter.
(4) For each investigation subject to § 812.2(b)(1) of a device other than a significant risk device, the
records described in paragraph (b)(5) of this section and the following records, consolidated in one
location and available for FDA inspection and copying:
(i) The name and intended use of the device and the objectives of the investigation;
(ii) A brief explanation of why the device is not a significant risk device:
(iii) The name and address of each investigator:
(iv) The name and address of each IRB that has reviewed the investigation:
(v) A statement of the extent to which the good manufacturing practice regulation in part 820 will be
followed in manufacturing the device; and
(vi) Any other information required by FDA.
(5) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints
and
(6) Any other records that FDA requires to be maintained by regulation or by specific requirement for a
category of investigation or a particular investigation.

(c) IRB records. An IRB shall maintain records in accordance with part 56 of this chapter.
(d) Retention period. An investigator or sponsor shall maintain the records required by this subpart
during the investigation and for a period of 2 years after the latter of the following two dates: The date
on which the investigation is terminated or completed, or the date that the records are no longer
required for purposes of supporting a premarket approval application, a notice of completion of a
product development protocol, a humanitarian device exemption application, a premarket notification
submission, or a request for De Novo classification.
(e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain
records for the period required in paragraph (d) of this section and transfer custody of the records to
any other person who will accept responsibility for them under this part, including the requirements of §
812.145. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.
All of the components above will be recorded and logged.
The study will also prepare reports as applicable and in compliance with FDA Title 21, Chapter 1,
Subchapter H, Section 812.150:
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and
timely reports:
(1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the
reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as
soon as possible, but in no event later than 10 working days after the investigator first learns of the
effect.
(2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working days, a
withdrawal of approval by the reviewing IRB of the investigator's part of an investigation.
(3) Progress. An investigator shall submit progress reports on the investigation to the sponsor, the
monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly.
(4) Deviations from the investigational plan. An investigator shall notify the sponsor and the reviewing
IRB (see § 56.108(a) (3) and (4)) of any deviation from the investigational plan to protect the life or
physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in
no event later than 5 working days after the emergency occurred. Except in such an emergency, prior
approval by the sponsor is required for changes in or deviations from a plan, and if these changes or
deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human
subjects, FDA and IRB in accordance with § 812.35(a) also is required.
(5) Informed consent. If an investigator uses a device without obtaining informed consent, the
investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the
use occurs.
(6) Final report. An investigator shall, within 3 months after termination or completion of the
investigation or the investigator's part of the investigation, submit a final report to the sponsor and the
reviewing IRB.
(7) Other. An investigator shall, upon request by a reviewing IRB or FDA, provide accurate, complete,
and current information about any aspect of the investigation.
(b) Sponsor reports. A sponsor shall prepare and submit the following complete, accurate, and timely
reports:

(1) Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated
adverse device effect under § 812.46(b) shall report the results of such evaluation to FDA and to all
reviewing IRB's and participating investigators within 10 working days after the sponsor first receives
notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as
FDA requests.
(2) Withdrawal of IRB approval. A sponsor shall notify FDA and all reviewing IRB's and participating
investigators of any withdrawal of approval of an investigation or a part of an investigation by a
reviewing IRB within 5 working days after receipt of the withdrawal of approval.
(3) Withdrawal of FDA approval. A sponsor shall notify all reviewing IRB's and participating
investigators of any withdrawal of FDA approval of the investigation, and shall do so within 5 working
days after receipt of notice of the withdrawal of approval.
(4) Current investigator list. A sponsor shall submit to FDA, at 6-month intervals, a current list of the
names and addresses of all investigators participating in the investigation. The sponsor shall submit the
first such list 6 months after FDA approval.
(5) Progress reports. At regular intervals, and at least yearly, a sponsor shall submit progress reports to
all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports
to FDA. A sponsor of a treatment IDE shall submit semi-annual progress reports to all reviewing IRB's
and FDA in accordance with § 812.36(f) and annual reports in accordance with this section.
(6) Recall and device disposition. A sponsor shall notify FDA and all reviewing IRB's of any request that
an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur
within 30 working days after the request is made and shall state why the request was made.
(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working
days of the completion or termination of the investigation and shall submit a final report to FDA and all
reviewing the IRB's and participating investigators within 6 months after completion or termination. In
the case of a device that is not a significant risk device, the sponsor shall submit a final report to all
reviewing IRB's within 6 months after termination or completion.
(8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under
paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 working
days of receipt of notice of such use.
(9) Significant risk device determinations. If an IRB determines that a device is a significant risk device,
and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the
sponsor shall submit to FDA a report of the IRB's determination within 5 working days after the sponsor
first learns of the IRB's determination.
(10) Other. A sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and
current information about any aspect of the investigation.
All of the reports above will be provided as indicated.
11. Ethical Considerations

The study is voluntary and prospective patients will be informed that participation in the study will not in
any way affect their access to care from Northwest Eye or Minnesota Eye Consultants. The
optimization/calibration phase of the study will be performed on study personnel and clinic employees.
There would be ethical concerns if study personnel or employees might feel coerced into having some
sort of treatment or be exposed to significant risk. In this study, this group of subjects will be voluntarily
participating, will sign a special consent, will need be receiving any treatment whatsoever, and will incur
no more risk than a conventional slit lamp examination. Consideration of recruiting patients to serve as
volunteers in this phase of the study was given, but this did not seem ethical as these calibrations can
be lengthy, somewhat tedious and physically fatiguing, especially for the predominately elderly clinic
population that subjects will be recruited from.
The sponsor, the principal investigator, and the technical officer/device trainer all have a financial
interest in the company that manufactures the device.
To minimize any conflict of interest, the prinicipal investigator, John S. Berestka, MD and the technical
officer/device trainer, Matthew L. Berestka, will be not allowed to be involved in the informed consent
process. Other staff members (all of whom have no financial or other conflict of interest) will perform the
informed consent process.
The study will comply with FDA Title 21, Chapter 1, Subchapter H, Section 812.43:
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to
investigate the device.
(b) Control of device. A sponsor shall ship investigational devices only to qualified investigators
participating in the investigation.
(c) Obtaining agreements. A sponsor shall obtain from each participating investigator a signed
agreement that includes:
(1) The investigator's curriculum vitae.
(2) Where applicable, a statement of the investigator's relevant experience, including the dates,
location, extent, and type of experience.
(3) If the investigator was involved in an investigation or other research that was terminated, an
explanation of the circumstances that led to termination.
(4) A statement of the investigator's commitment to:
(i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and
other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA;
(ii) Supervise all testing of the device involving human subjects; and
(iii) Ensure that the requirements for obtaining informed consent are met.
(5) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and
accurate certification or disclosure statement as required under part 54 of this chapter. The sponsor
shall obtain a commitment from the clinical investigator to promptly update this information if any
relevant changes occur during the course of the investigation and for 1 year following completion of the
study. This information shall not be submitted in an investigational device exemption application, but
shall be submitted in any marketing application involving the device.
(d) Selecting monitors. A sponsor shall select monitors qualified by training and experience to monitor
the investigational study in accordance with this part and other applicable FDA regulations.

All of the components above will be provided.
STUDY SUMMARY