Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness
Phase: NA
Conditions: Corneal Disease, Corneal Opacity, Corneal Injuries
Sponsor: CorNeat Vision Ltd.

Company Confidential
Document Name :KPro - FIH - Canada - Clinical Investigational Protocol
Doc No :DMS-15012
Revision :L-2
Approved Date :20-Oct-2022
Cover Page
File Name :KPro-FIH-Canada-Clinical
Investigational Protocol.docx
Routing State : Approved
Approvals :
Job Title
Approved by
Quality Role
Date
Signature status
Comment
CRA
Ido Klein
Approver
20-Oct-2022
Approved
CMO
Gilad Litvin
Approver
20-Oct-2022
Approved
VP QA / RA /
CA
Gerry Tal
Approver
20-Oct-2022
Approved
Change Revision History :
Rev.
Date
Change Description
ECO
Release Date
L
20-Oct-2022
Section 10.11 - Premature
Termination or Suspension of the
Study was added
K
23-May-2021
Section 4.2.3 - Table 1 (CorNeat
KPro lens features) - revised per
updated IFU
•
Section 4.2.7 - Implantation
procedure - revised to include a
description of the removal of flanges
procedure and per updated IFU
•
Section 8.1.5 - Post-operative
supportive care - added a
requirement to instruct the patient to
wear UV-blocking sunglasses after
surgery. 
•
ECO-27286
13-Jul-2021
J
06-Jan-2021
Added section 10.9 - Device
Explantation
•
Added reference to IOP
measurements in section 8.1.6
•
Added section 8.1.5 - Post operative
Supportive Care
•

I
01-Oct-2020
Changes were made to section 4.2.2.
"Optics" per Health Canada's
comments received on 24.9.2020
H
06-Jul-2020
Safety management was revised to
state that SAE reporting to the
Sponsor will be done via the EDC
system
G
01-Jul-2020
Pseudophakia was added as an
inclusion criteria
•
References pertaining IOL
implantation during the CorNeat
KPro surgical procedure were
omitted
•
Unanticipated Adverse Device-
related Event (UADE) definition was
added (section 10.5)
•
F
11-May-2020
Hospitaization period will be per the
PI's discretion (estimated 1 day)
E
07-May-2020
The word "plan" was replaced with the
word "Protocol"
D
28-Apr-2020
Added specification for IOP
measurement technique
•
Added a recommendation for
hospitalization of 2 days after the
surgery
•
C
10-Feb-2020
Format correction (PDF was uploaded
to QMS)
B
10-Feb-2020
typographical errors correction and
minor phrasing improvements were
made.
1.
Section 2 - Abbreviations were
added
2.
Section 8.2 – Minor inclusion &
exclusion criteria adjustments were
made
3.
Section 5.2.3 – Two notes were
added: 1. Regarding the preference
that patients should be
pseudophakic at the end of the
procedure; 2. Regarding the
requirement that an extra CorNeat
KPro unit and a corneal graft will be
4.

ready in the operating room
Section 9.1.3 – Intraoperative
evaluation procedure was
corrected
5.
Section 9.2 – Table of
Assessments was corrected
according to the actual planned
schedule of procedures
6.
Section 11.7 – Known Potential
Risks section was added.
7.
Header and footer were changed to
comply with document control
format of the QMS
8.
A
10-Feb-2020
Baseline
Document Control / Clinical Affairs / KPro / FIH Study / Canada / Study Documents/ KPro - FIH - Canada -
Clinical Investigational Protocol

CorNeat KPro - Clinical Investigational Protocol 
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Page 1 of 41 
 
 
 
CLINICAL INVESTIGATIONAL PROTOCOL 
 
Study Name: 
Prospective, open label, single arm, First in Human (FIH) clinical 
study to assess Safety and efficacy of the CorNeat 
Keratoprosthesis for the treatment of corneal blindness 
 
Sponsor: 
CorNeat Vision 
Email: info@CorNeat.com 
4 Hasheizaf St. Raanana, Israel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to 
anyone other than the Sponsor, the Investigator Team, regulatory authorities, and 
members of the Research Ethics Committee. 
 

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Page 2 of 41 
 
Table of Contents 
1 
Abbreviations ............................................................................................................... 4 
2 
Investigator Agreement ............................................................................................... 5 
3 
Study Synopsis ............................................................................................................ 6 
4 
Introduction .................................................................................................................. 9 
4.1 
Background Information ................................................................................................... 9 
4.1.1 
Clinical Context ......................................................................................................... 9 
4.1.2 
Standard Of Care (SOC) ........................................................................................ 10 
4.2 
Device Description ......................................................................................................... 11 
4.2.1 
Product Overview .................................................................................................... 11 
4.2.2 
Optics ...................................................................................................................... 12 
4.2.3 
Properties Relevant to the Clinical Function .......................................................... 13 
4.2.4 
Indications for Use .................................................................................................. 15 
4.2.5 
KPro Indications ...................................................................................................... 16 
4.2.6 
PKP Indications ....................................................................................................... 16 
4.2.7 
Implantation Procedure ........................................................................................... 16 
4.2.8 
Principles of Operation ........................................................................................... 20 
4.2.9 
Regulatory History .................................................................................................. 24 
5 
Study Objectives And Endpoints ............................................................................... 24 
5.1 
Objective ......................................................................................................................... 24 
5.2 
Endpoints........................................................................................................................ 25 
5.2.1 
Primary Safety Endpoint ......................................................................................... 25 
5.2.2 
Effectiveness Endpoints: ........................................................................................ 25 
6 
Study Design .............................................................................................................. 25 
7 
Study Population and Subject Selection ................................................................... 25 
7.1 
Study Population ............................................................................................................ 25 
7.2 
Subject Selection............................................................................................................ 26 
7.2.1 
Inclusion Criteria ..................................................................................................... 26 
7.2.2 
Exclusion Criteria .................................................................................................... 26 
7.3 
Informed Consent ........................................................................................................... 27 
7.4 
Replacement of Dropouts .............................................................................................. 27 
8 
Trial Procedures......................................................................................................... 27 
8.1 
Visit Schedule ................................................................................................................. 27 

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8.1.1 
Screening and Consent .......................................................................................... 27 
8.1.2 
Implantation............................................................................................................. 28 
8.1.3 
Operative Evaluation............................................................................................... 28 
8.1.4 
Procedural Failures ................................................................................................. 28 
8.1.5 
Post-Operative Supportive Care............................................................................. 28 
8.1.6 
Follow Up ................................................................................................................ 29 
8.2 
Table Of Assessment ..................................................................................................... 30 
9 
Training ...................................................................................................................... 31 
10 
Safety Parameter ................................................................................................... 31 
10.1 
Adverse Event Definition ................................................................................................ 31 
10.2 
Severity of an Adverse Event ......................................................................................... 31 
10.3 
Relationship to Study Device ......................................................................................... 32 
10.4 
Serious Adverse Event Definition .................................................................................. 32 
10.5 
Unanticipated Adverse Device-related Event Definition ................................................ 32 
10.6 
Adverse Event Reporting ............................................................................................... 33 
10.7 
Serious Adverse Events Reporting and Unanticipated Adverse Device-Related Events 
(UADE) ...................................................................................................................................... 33 
10.8 
Known Potential Risks ................................................................................................... 34 
10.9 
Device Explantation ....................................................................................................... 35 
10.9.1 
Potential Clinical Scenarios Resulting in Device Explantation .............................. 35 
10.9.2 
Device Explantation Procedure .............................................................................. 36 
10.10 
DSMB .......................................................................................................................... 36 
10.11 
Premature Termination or Suspension of the Study .................................................. 36 
11 
Insurance ................................................................................................................ 37 
12 
Data Collection, Processing and Statistical Analysis ............................................ 37 
12.1 
Data Collection and Processing ..................................................................................... 37 
12.1.1 
Subject Data Protection .......................................................................................... 37 
12.2 
Statistical Analysis and Sample Size ............................................................................. 37 
12.2.1 
Sample Size Consideration .................................................................................... 37 
12.2.2 
Sample Size Justification ........................................................................................ 38 
12.2.3 
Statistical Analysis .................................................................................................. 38 
12.3 
Monitoring Procedures ................................................................................................... 38 
12.3.1 
On-Site Monitoring .................................................................................................. 38 
12.4 
Study Site Initiation ........................................................................................................ 39 
12.5 
Protocol Changes or Amendments ................................................................................ 39 

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12.6 
Case Report Forms (CRF) ............................................................................................. 39 
12.7 
Maintenance of Study File ............................................................................................. 40 
12.8 
Device Accountability ..................................................................................................... 40 
12.9 
On-Site Audits ................................................................................................................ 40 
12.10 
Reports ....................................................................................................................... 40 
12.11 
Disclosure and Publication of Information.................................................................. 40 
 
 
1 Abbreviations 
ICF 
Informed Consent Form  
FIH 
First In Human 
OCT 
Optical coherence tomography 
DSMB 
Data-safety-monitoring-board 
REB 
Research Ethics Board 
MedDRA,  Medical Dictionary for Regulatory Activities 
EC 
Ethics Committee  
KPro 
Keratoprosthesis 
PT 
Preferred Term 
OD 
Right eye 
OS  
Left eye 
SAE 
Serious Adverse Events 
eCRF 
Electronic Case Report Form 
BCVA 
Best Corrected Visual Acuity 
VAS 
Visual Analogue Scale 
SOC 
Standard Of Care 
SAP 
Statistical Analysis Plan  
UADE 
Unanticipated Adverse Device-related Events  
 
 
 

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2 Investigator Agreement 
I have read and understand the protocol and agree that it contains all the ethical, legal 
and scientific information necessary to conduct the Study. I confirm that I am legally and 
technically qualified to serve as an investigator for this clinical trial and agree to 
personally conduct and supervise the described study. I agree to conduct the study as 
detailed herein and in compliance with ISO 14155 and applicable regulatory 
requirements. I will provide copies of the protocol to all physicians, nurses and other 
professional personnel who will participate in the study. I will discuss the protocol with 
them to assure myself that they are sufficiently informed regarding the investigational 
device used in the trial, the permitted concurrent medications, the efficacy and safety 
parameters, the conduct of the study and their roles and responsibilities in the study. 
Furthermore, I understand that any changes in the protocol must be approved in writing 
by the Sponsor and subsequently must be approved by the reviewing Ethics 
Committee/ Research Ethics Board, prior to their implementation; except when 
necessary to protect the safety, the rights or welfare of subjects. 
I agree to allow sponsor monitors and auditors as well as inspectors from regulatory 
authorities, full access to all source documents, including medical records, at the 
research facility for subjects screened in the study. 
A signed, written informed consent form will be obtained from all subjects or the 
subject’s legally authorized representative and the date that this consent was obtained 
will be appropriately documented in the subject’s medical file.  
I further agree to report to the sponsor any adverse experiences in accordance with the 
terms of this protocol, local regulation, and ISO 14155. 
______________________________________________________________________ 
 
Principal Investigator Name (Print) _______________________________  
 
Principal Investigator (Signature) _________________Date ___________________ 
 
Medical Center Name: ___________________ 
 
 
 
 
 

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3 Study Synopsis 
Study Name:   
Prospective, open label, single arm, First in Human clinical study to assess Safety and efficacy 
of the CorNeat Keratoprosthesis for the treatment of corneal blindness   
Objectives: The objective of this clinical study is to prove the safety of the CorNeat 
Keratoprosthesis (KPro).  
Study endpoints:  
Primary Safety Endpoint: 
The frequency and severity of all unanticipated adverse device-related events (UADE) or 
treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 
12 months should be less than SOC (as detailed in section Known Potential Risks). 
Effectiveness Endpoints: 
Primary Endpoint: Retention of implant 
Secondary Endpoint: Improved visual acuity 
Intended uses: The CorNeat KPro’s intended use is to treat corneal blindness, by providing a 
clear optical media, in patients with an opaque cornea, who are not suitable candidates for 
Keratoplasty. 
Study Population: 10 subjects suffering from unilateral or bi-lateral corneal blindness, not 
reasonably amenable by transplanting human tissue. The KPro can be implanted in OD or OS 
(selection is according to PI discretion).  
Study Duration: Subjects will be followed up for 12 months following device implantation  
  
Inclusion criteria – (i) Male or female aged ≥ 18 and ≤ 80 years on the day of screening; (ii) 
Candidates must have the ability and willingness to attend all scheduled visits and comply with 
all study procedures; (iii) keratoprosthesis surgery is indicated in cases when keratoplasty is not 
a reasonable option or following a verifiable history of prior failed corneal transplantation. 
(iv)Indications that fall under poor candidate for keratoplasty include but are not limited to: 
herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven 
Johnson Syndrome, and limbal stem cell deficiency; (v) pseudophakia; (vi) adequate tear film 
and lid function; (vii) perception of light in all quadrants; (viii) Female patients of childbearing age 
must have negative pregnancy test at screening and agree to use an effective method of 
contraception throughout the study. 
Exclusion criteria – (i) reasonable chance of success with traditional keratoplasty; (ii) current 
retinal detachment; (iii) connective tissue diseases; (iv) end stage glaucoma; (v) history or 
evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes 
within 6 months prior to planned implantation; (vi) history of ocular or periocular malignancy; (vii) 
history of extensive keloid formation; (viii) any known intolerance or hypersensitivity to topical 
anaesthetics, mydriatics, or component of the device; (ix) signs of current infection, including 
fever and current treatment with antibiotics; (x) severe generalized disease that results in a life 
expectancy shorter than a year; (xi) any clinical evidence that the investigator feels would place 

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Page 7 of 41 
 
the subject at increased risk with the placement of the device; (xii) corneal thickness less than 
400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be 
operated; (xiii) currently pregnant or breastfeeding; (xiv) participation in any study involving an 
investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever 
longer) or ongoing participation in a study with an investigational drug or device and; (xv) 
intraoperative complication that would preclude implantation of the study device; (xvi) Vulnerable 
populations 
Patients who meet all inclusion criteria and none of the exclusion criteria will be enrolled 
in the protocol and implanted with the CorNeat Kpro device. 
 
Visit Schedule:  
• Screening: 
Day -14-0, Subjects will sign ICF on screening visit and baseline assessment will be 
performed.  
• Baseline examinations and Implantation:  
Implantation day will be recorded as day 0; enrolment day.  
• Follow Up- (up to 12 months) visit schedule: One day post op, one week, one, two three, six, 
nine- and twelve-months post-surgery. 
On each follow-up visit, subjects will be subjected to the following examinations: (i) slit-lamp 
biomicroscopy, (ii) visual acuity (BCVA), (iii) IOP, (iv) concomitant medications record, (v) Pain 
assessment and (vi) Adverse events recording. In addition, OCT/UBM imaging will be performed 
on screening visit, on 1week post-op and every 3 months starting at 3 months post-surgery. 
 
Sample size consideration: 
Sample size of 10 patients for FIH study to assess the safety of the application on a non-
statistical basis According to FDA guidance document for Keratoprosthesis, a sample size of 20 
patients is required for product 510(k) approval Guidance dated March 3, 1999 
 
Sample size justification: 
Reference to FDA guidance for Keratoprosthesis 510K where proving safety is the target and 20 
subjects with a minimum of 330 days of follow up is needed.  
 
Safety Assessment: A record of UADE, Incidence and nature of serious adverse events (SAE), 
Incidence and nature of adverse events 
will be collected throughout the study starting from implantation visit. 
The ten first implanted subjects will comprise the FIH cohort. Once the 10th subject successfully 
completes the 6th month post-surgery follow-up, an independent data-safety-monitoring-board 
(DSMB) will review the data and submit its conclusions to the ethics committee/REB and 
regulatory authority.  

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All adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA, 
most updated version) terminology and presented in tables by System Organ Class (SOC) and 
Preferred Term (PT).  
AE data will be listed individually and summarized by SOC and by PT within a system organ 
class. 
Additional tables will present adverse events by PT, SOC and severity and by relatedness to 
study device.   
 
Ethics Committee /REB and regulatory authority 
The study protocol, IB describing the device, its materials, manufacturing process, verification 
and validation tests and the ICF, which will be in compliance with the study protocol will be 
submitted to the ethics committees in the participating clinical sites and the respective governing 
regulatory authorities. The study can start once ethics committees and regulatory authority 
approval is granted.  
 
Surgeons training for conduct of the clinical trial  
• 
Ophthalmologist training prior to subject enrolment: presentation and wet lab to practice, 
leveraging a real animal model and where available Human cadaver eyes. The goal of 
this phase is to train the ophthalmologists who will participate in the study.  
 
Preparation of eCRF and EDC database for data management 
The electronic Case Report Form (eCRF) will collect subjects’ data during study visits. These 
include: (i) recording of adverse events; (ii) any concomitant medications if applicable; (iii) 
demographic data; (iv) medical history; (v) surgical outcome and; (vi) primary and secondary 
endpoint parameters. The data collected by the eCRF will be accumulated in an Electronic Data 
Capture (EDC) system database. Data will be entered by study staff during the study and at its 
conclusion by data management personnel corresponding with the study monitor and site 
investigators. It will be collected by data improvement through queries, which is automatic using 
the system’s edit checks while data is typed in, and manually following source data verification 
(performed at monitoring visits). The EDC system will be in compliance with GCP and with 
Directive 95/46/EC of the European Parliament and of the Council of 24th of October 1995 on the 
“Protection of individuals with regard to the processing of personal data and on the free 
movement of such data”.  
 
Statistical considerations 
Statistical calculations are not required in this FIH study 
 
Conduct of clinical study   
Subjects will be screened by the participating clinical sites’ clinical team (physician and study 
staff) during a screening visit. Each subject will sign the ICF (Informed Consent Form) prior to 
any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible 

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Page 9 of 41 
 
subjects will be enrolled in the study. Demographic data, medical history and concomitant 
medication use data will be collected from enrolled subjects. Subjects will be implanted with the 
CorNeat KPro, and followed-up over a period of 12 months in 8 clinic visits. During follow up 
visits safety data and use of concomitant medication will be documented. Subjects accrual is 
planned for a maximum of 12 months and overall first subject in to last subject out is planned for 
24 months.  
Follow up plan will include complete clinical exam, anterior segment photography and a 
questionnaire assessing pain and other possible subjective ramifications.  
Monitoring of the clinical study 
The sponsor will ascertain that the clinical trial is adequately conducted and perform monitoring 
activities including: sites’ initiation, monitoring visits to ensure adherence of sites to the study 
protocol and GCP, data management activities, sites close out and preparation of final clinical 
study report. During monitoring visit source data verification will be performed. The CRA will 
assist in the application submission to the ethics committees and regulatory authorities. The 
CRA will be responsible for ongoing communication with the ethics committees and regulatory 
authorities as applicable and as required during the trial. 
The CRA will perform its activities following a written and signed delegation of responsibility 
letter. 
Safety management 
Any adverse events will be documented and monitored according to the monitoring plan. 
Reporting of adverse events and serious adverse events will be done as per GCP, ISO 
14155:2011 and local regulations. PI will document all serious adverse events (SAE) on the SAE 
Report Form. SAE will be transmitted to CorNeat Vision via the EDC system.  Sponsor’s medical 
monitor will oversee safety management of the study.  
 
4 Introduction 
4.1 
Background Information 
4.1.1 Clinical Context 
Corneal pathology is a leading cause of blindness worldwide with 20-30 million patients in need 
of a remedy and around 2 million new cases/year.1 The epidemiology of corneal blindness is 
complex and encompasses injury and a wide variety of infectious, genetic, and inflammatory 
eye diseases, which cause corneal scarring or opacity and lead to functional blindness. Current 
solutions for corneal blindness and disease include penetrating keratoplasty (PKP; corneal 
transplantation), lamellar keratoplasty (DMEK, DALK), and rarely keratoprosthesis (KPro; 
artificial cornea implantation). Together, keratoplasty and to a much lesser extent KPros 
 
1  Corneal blindness: a global perspective, John P. Whitcher; M. Srinivasan; Madan P. Upadhyay; Bulletin 
 of the World Health Organization, 2001.  

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Page 10 of 41 
 
address 5%-10% of global cases.2 Though a profound cause of distress and disability, 
transplanting tissue is carried out only around 200,000 times/year worldwide.3  
In the USA, where there is no shortage in corneal tissue,2 51,294 corneal transplantations were 
performed during 2018, of them the number of PKP grafts was 17,347.4 Long term graft survival 
rate following PKP is estimated at 90% after 5 years and 82% at 10 years for first time grafts 
and 53% and 41% for first re-grafts.5 These performance rates, plus the fact that some corneal 
blindness indications are not suitable for keratoplasty, translates to an ever-growing number of 
patients for whom there is no suitable solution. Moreover, given the fact that visual acuity 
following PKP depends on the tissue quality, the surgery, the medical indication, and the patient 
vision potential, many of the patients undergoing PKP are left with poor vision. 
Several attempts to develop an artificial cornea have failed in creating robust, scalable and 
reliable solutions. As such, there exists an unmet need for an efficient, long-lasting and 
affordable solution to corneal pathology, injury and blindness, which would alleviate this 
suffering and disability and enable patients to fully exploit their vision potential.  
4.1.2 Standard Of Care (SOC) 
The transplantation of corneal tissue – keratoplasty – is the method of choice for the 
replacement of damaged and/or diseased corneal tissue. However, keratoplasty, as a mean for 
restoring the patient’s vision has not effectively resolved all, or even most cases of corneal 
pathology, due to graft failure, graft retention, and the paucity of harvested, viable, tissue.  
In the USA and other countries with mature eye banking, approximately 20% of patients have 
either failed one or more transplantations or are not a suitable candidate for one. Indications 
such as recurrent herpes keratitis, ocular cicatricial Pemphigoid, Steven Johnson’s syndrome, 
rejected graft and vascularized cornea are not suitable for keratoplasty and currently have no 
available solution. 
An artificial solution would solve many shortcomings of the Standard of Care (SOC) and 
therefore alleviate the suffering of scores of affected individuals, predominantly in the 
developing world. So far, attempts at creating scalable KPros have failed. Whereas previous 
keratoprostheses (KPros; see Appendix I for comparison to the Boston KPro) have integrated 
an artificial lens into a biological substrate and was then implanted into the eye, the CorNeat 
KPro is completely synthetic, involving a microporous skirt and leveraging the subconjunctival 
space.  
 
2  Global Survey of Corneal Transplantation and Eye Banking. Gain P1, Jullienne R; He Z; Aldossary M; 
 Acquart S; Cognasse F; Thuret G 
3 The value of corneal transplantation in reducing blindness; Garg P; Krishna PV; Stratis AK; Gopinathan 
 U; Eye (Lond). 2005 Oct;19(10):1106-14. 
4  Eye bank association of America 2018 statistical report. 
5  Long-term graft survival after penetrating keratoplasty, Robert W Thompson Jr.,Marianne O Price, Patrick 
 J Bowers, Francis W Price Jr., Ophthalmology, July 2003, Volume 110, Issue 7. 

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Page 11 of 41 
 
4.2 
Device Description 
4.2.1 Product Overview 
The CorNeat KPro is a synthetic cornea developed to provide a long-lasting medical solution for 
corneal blindness, pathology and injury. The solution is designed to provide an accessible, 
efficient, effective and reliable remedy for people with cornea-related visual impairments.  
The CorNeat KPro implant is a patented synthetic cornea that utilizes a novel polymeric bio-
integrating skirt to assimilate synthetic optics within resident ocular tissue. Currently available 
solutions rely either on donor tissue (keratoplasty) or on synthetic implants mounted on 
biological carrier tissues then attached to the native corneal tissue – a tissue lacking blood 
vessels and healing capacity. In contrast, the CorNeat KPro integrates seamlessly with the 
eyewall, underneath the fibroblast-rich and aggressively scarring site of the conjunctiva. 
The CorNeat KPro implant (Figure 1) consists of two main components: a lens made of 
polymethyl methacrylate (PMMA) and a porous integrating skirt surrounding it, made of non-
woven and non-degradable medical grade polyurethane mesh.  
 
Figure 1: CorNeat KPro main components 
The CorNeat KPro is supplied with a set of dedicated implantation tools meant to facilitate a 
novel and relatively simple surgical procedure, which does not require human tissue and can be 
performed by most ophthalmic surgeons. The CorNeat KPro implantation kit is depicted in 
Figure 2. The CorNeat KPro solution, its principles of operation, and corresponding surgical 
procedure have been proven safe and reliable in multiple preclinical studies and animal 
implantations. The solution is poised to significantly impact US and global corneal blindness 
treatment as it is significantly superior to any available alternatives. 

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Figure 2: The CorNeat KPro implantation kit 
4.2.2 Optics 
a. The CorNeat KPro’s optical element is made of medical-grade PMMA. It provides excellent 
light transmission as well as UV and hydro stability. The lens is designed to provide a fixed 
optical power, which is equivalent to that of a normal cornea. The lens, which extends 
almost the entire way to the limbus (10mm in diameter), provides an effective optical zone 
approximately 6.5mm in diameter, enabling the patient to benefit from a wide field of view. It 
also enables the ophthalmologist to examine the patient’s eye and perform cataract and 
retinal surgery post implantation, if necessary. Such surgical procedures can be performed 
through the 4 access ports located on the rim of the PMMA optics.  
The current optical power of the CorNeat KPro is normalized to 42 D (Figure 3), similar to 
the naitive cornea and will enable patients to regain sight.. The CorNeat KPro optical design 
is expected to deliver unprecedented Best Corrected Visual Acuity (BCVA) with no 
astigmatism.  
b. In order to eliminate potential astigmatism due to device malposition/decentration, the 
CorNeat KPro lens’ surfaces are spherical. 
c. Any previously implemented IOL was chosen with a dioptric power that has been calculated 
to enable optimal visual acuity with the patient’s native or previously implanted cornea, prior 
to becoming opaque and requiring Kpro implantation. The range of corneal optical power is 
not as extensive as that of IOLs. IOL power is mainly influenced by axial length. The 
residual, post-surgical, optical error is expected to be mild to moderate and one that can be 
corrected by the aid of spectacles in case of need. The CorNeat KPro can be implanted in 
any pseudophakic patient and following the implantation the refractive error will be 
determined and spectacle correction will be prescribed in case of need. 
Patients meeting the inclusion and exclusion criteria suffer from serious vision impairment 
in one or both eyes. These patients will regain vision but to achieve their full vision potential 
might need to use spectacles. We believe regaining sight outweighs the surgical and post-
surgical risks which are mitigated as far as possible.  

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Figure 3: Schematic eye (ZEMAX Ray diagram) with (a, left) natural cornea, and (b, right) KPro 
cornea. 
4.2.3 Properties Relevant to the Clinical Function 
The following Figure 4 depicts the CorNeat KPro’s anterior and posterior sides. The sections 
below outline the device features relevant to the clinical function. 
 
Figure 4: CorNeat KPro - anterior and posterior sides 
Lens 
The CorNeat KPro lens (Figure 5) is made from medical grade PMMA. This material is known to 
be safe and has been used extensively for manufacturing intra-ocular lenses. PMMA is used 
also for manufacturing FDA-approved KPros, such as the Boston KPro and Osteo-Odonto KPro. 
Figure 5 depicts the CorNeat KPro lens Figure 5. Figure 6 and Table 1 outline the CorNeat KPro 
lens’ features relevant to clinical functions. 
 
Figure 5: CorNeat KPro Lens 

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Figure 6: CorNeat KPro lens features 
 
Table 1: CorNeat KPro lens features 
Feature 
Relevance to clinical function  
Corneal undercut/Corneal 
opening 
The lip on the posterior side of the lens hosts the patient’s corneal 
stump. It has a wide opening that can accommodate thick or 
edematous corneas (up to 1.5mm think). This wide opening also allows 
for aqueous humor to reach the edge of the cornea, maintain its health 
and avoid or minimize thinning or melting. 
In order to keep the eye watertight immediately post-implantation, the 
undercut wall diameter is slightly larger than the trephination diameter. 
Posterior turret 
 
A set of flanges on the posterior side of the lens assist the surgeon 
with the implant fitting process, and secure the remnant cornea in 
place. The flanges enable a methodological fitting process as they 
eliminate the chances of the cornea slipping out of the undercut after 
being placed into it. 
Integration rim 
Suturing 
holes 
3 pairs of suturing holes are positioned on the lens’ rim, 120 degrees 
apart. These holes enable suturing the lens to the eye wall at the area 
of the limbus using non-degradable sutures. The suturing of the device 
to the eye ensures its centration, retention and bio-integration. It also 
facilitates the process of fitting the patient’s cornea into the KPro 
corneal undercut.  
Superior 
Suturing 
holes 
The superior suturing holes are placed at the 12 o’clock position 
assisting in correct alignment of the device. 
Access 
ports 
4 access ports (openings) on the rim of the PMMA lens positioned 
around the limbus enable penetrating the anterior chamber with 
surgical tools . Insertion of surgical instruments into the anterior 
chamber or vitreous cavity allows intraocular surgical procedures to be 
performed after CorNeat KPro implantation, if necessary. Ports are 
positioned in locations consistent with current best practices for 
cataract and retinal surgery for both right and left eyes.   
Main 
access port 
The main access port, which should be positioned at 11 o’clock, is 
2.6mm wide. This port is designed to enable IOL injection following 
KPro implantation. 

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Port 
indicators 
 
Following implantation, the integration rim, including the access ports, 
are expected to be covered by conjunctiva. A set of indicators on the 
optic’s edge that are visible under a microscope assist the surgeon in 
locating the access ports post implantation. 
The port indicators, which are essentially tiny “bumps” on the surface 
of the PMMA, are placed on the edge of the central optical zone; one 
opposite each access port, and two opposite the main access port. 
Integration 
holes 
 
The integration holes on the rim of the lens are filled with the skirt 
material. Connective tissue is expected to grow through these holes, 
practically “biostitching” the PMMA lens onto the sclera. This 
mechanism further ensures device attachment, mitigating risks of 
detachment in case the skirt fibers weaken or detaches from the lens. 
 
Integrating skirt 
The CorNeat KPro integrating skirt is made from a flexible, durable and non-degradable porous 
material that stimulates cellular proliferation. The skirt is 250 microns thick and easily placed 
under the conjunctiva. The skirt extends 6mm from the edge of the lens transparent zone (1cm 
in diameter) and ends approximately 1mm from the closest insertion of the extraocular muscles 
(spiral of tillaux). 
The skirt dimensions are designed to fit most eyes. Nonetheless, it can be easily cut and 
adjusted by the surgeon to fit any eye.  
4.2.4 Indications for Use 
The ultimate intent of CorNeat Vision is to approve the CorNeat KPro as an alternative to SOC 
- penetrating, or full thickness, corneal transplantation (Penetrating Keratoplasty, PKP) 
where patient tissue is replaced with donor tissue. Section 4.2.6 below outlines PKP indications. 
Given the commercial and clinical risks involved, CorNeat Vision plans to undertake a stepwise 
approach, initially seeking approval of the CorNeat KPro device and implantation kit for patients 
who are poor candidates for PKP. For these indications there is a regulatory precedent as 
documented in FDA guidance on 510(k) submissions for KPros dated March 3, 1999. These 
initial indications for use are similar to those that apply to commercially available synthetic 
corneal implants, such as the Boston KPro. Section 4.2.54.2.5 outlines current indications of 
use for KPros. The initial intended use for the CorNeat KPro is defined below and is consistent 
with the FDA’s definition of Class II special controls. 
Per the FDA guidance for the initial first step, The CorNeat KPro device will be defined as a 
“keratoprosthesis device implanted permanently to provide a transparent optical pathway 
through an opacified cornea in an eye that is not a reasonable candidate for a corneal 
transplant.” 
As a second step, and once the device safety is validated in a limited clinical study (per the 
applicable FDA guidance), CorNeat Vision plans to take the necessary steps and initiate 
additional clinical trial/s and expand the indications for use to also cover those of PKP.  
In the treatment of corneal opacities, keratoplasty is the SOC. For some medical indications 
causing corneal opacities, failure rates of keratoplasty are unacceptable. Patients not suitable 

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for keratoplasty may attempt keratoprosthesis implantation as a last resort. The following 
sections outline the major indications for both patient groups. 
4.2.5 KPro Indications 
• 
Following corneal transplantation failure 
• 
Vascularized cornea (at least two quadrants) 
• 
Disciform corneal scar due to herpetic keratitis 
• 
Stevens-Johnson syndrome (SJS) 
• 
Ocular cicatricial pemphigoid (OCP) 
• 
Autoimmune diseases 
• 
Ocular burns (acid and alkali) with stem cell deficiency  
• 
Other conditions with poor prognosis with traditional PKP 
4.2.6 PKP Indications 
• 
Keratoconus and ectasias 
• 
Corneal degenerations 
• 
Corneal dystrophies including Fuchs endothelial dystrophy 
• 
Ulcerative keratitis infectious and non-infectious 
• 
Post infectious keratitis 
• 
Congenital opacities 
• 
Chemical injuries without stem cell deficiency  
• 
Mechanical trauma 
• 
Refractive indications 
• 
Regraft related to allograft rejection 
• 
Regraft unrelated to allograft rejection 
4.2.7 Implantation Procedure 
The CorNeat KPro implantation procedure is relatively short (30-45 minutes) and simple when 
compared to keratoplasty and other KPros. Unlike current practices requiring delicate suturing 
of transparent donor corneal tissue to the patient’s native cornea – a process which is 
performed by very skilled and well-trained ophthalmic surgeons – the CorNeat KPro snaps into 
the patient’s trephined cornea and is sutured to the eye wall using 3 non-degradable sutures. 
The provided Marker and Snapper tools enable precise fitting of the device, yielding a well-
developed implantation process, which can be taught in a few hours. The process itself 
minimizes the time the eye is trephined and open (also known as “open sky”) to less than one 
minute, significantly reducing the risk of infection, expulsive hemorrhage, and other 
complications.  
 
Optional: In cases where the recipient cornea is suspected of being overly stiff, it is 
recommended to remove two of the posterior rim flanges to facilitate extension of the trephined 
corneal stump around the posterior turret and insertion into the undercut. If required, place the 

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KPro on a sterile gauze pad under a microscope, and locate the 2 o’clock and 4 o’clock flanges 
using the port indicators (note that when viewing the implant from the posterior aspect, the clock 
positions are anti-clockwise- see Figure 5). Gently hold down the implant using a soft swab and 
using a needle holder or other tool, grasp the 2 o’clock flange. Bend the flange inward from the 
posterior turret to completely break it off. The flange stump should be nearly flush with the 
posterior rim or slightly recessed (see Figure 6). Repeat the procedure with the 4 o’clock flange. 
Examine the lens for any cracks, residual sharp edges, particles or lens damage before 
proceeding. 
 
Figure 7 - Note the clock positions of the 
posterior rim flanges relative to the port 
indicators. 
  
Figure 8 - Illustration of flange removal from 
the posterior turret 
 
 
 

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Table 2: CorNeat KPro implantation procedure steps 
Step 
# 
Description 
Illustration 
1. 
Perform peritomy 360°, creating a deep 
pocket.  
 
 
2. 
Completely debride the corneal epithelium  
 
3. 
Mark the center of the cornea with a surgical 
marker. This ensures that subsequent critical 
procedure steps are aligned. 
 
4. 
Cornea marking. Using the dedicated Marker 
tool, the cornea surface is marked. The 
marked pattern includes 3 pairs of suturing 
marks, 4 potential paracenteses lines, and a 
trephination edge mark. The marker head is 
transparent and includes a rounded hole 
centered on the cornea by aligning it with the 
central mark. The marker and implant are not 
symmetrical, and care should be taken to 
align the superior suturing marks with the 
corneal 12 o’clock position. 
 
 

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Step 
# 
Description 
Illustration 
5. 
Paracenteses + OVD. Two clear corneal 
incisions are created where indicated by the 
paracentesis line, and the eye is filled with 
viscoelastic (OVD).  
 
6. 
 Preplace 3 pairs of non-degradable sutures, 
passing first through dedicated holes on the 
rim of the KPro’s optics, and then through the 
cornea – entering at the suture hole marks, 
passing radially through the sclera. Double 
armed sutures are recommended. Be sure to 
align the sutures so that they do not cross or 
become entangled. Inspect the rim of the 
KPro implant to ensure its integrity before 
implantation. 
 
 
7. 
 Once all preparatory steps are completed, 
trephine the central cornea . Align the 
trephine crosshairs with the central corneal 
mark to achieve centration. 
 
8. 
Fasten the implant to the device is fastened 
to the eye wall by tightening the 3 sutures, 
and then tying them between the device skirt 
and the sclera.  
  
 

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Step 
# 
Description 
Illustration 
9. 
Using the Snapper, Insert the trephined 
corneal edge, which is stained for better 
visualization, into the KPro’s posterior 
(corneal) undercut. 
 
10. 
Exchange the viscoelastic (OVD) with 
balanced salt solution (BSS). 
 
11. 
Reposition the conjunctiva and suture into 
place using degradable sutures. The 
conjunctiva should completely cover the 
skirt.,Following conjunctival suturing, apply 
tissue adhesive to ensure tissue 
approximation during the initial healing 
period. 
 
In every implantation procedure, an extra CorNeat KPro unit and a corneal graft will be ready in 
the operating room and will be used in case of an unexpected intraoperative complication 
preventing implantation of the dispensed CorNeat KPro unit. 
A full animated video of the CorNeat KPro implantation procedure can be found on the CorNeat 
Vision website here: https://www.CorNeat.com/kpro-animation 
 
Figure 9: CorNeat KPro implantation animation (CTRL+Click to access) 
 
4.2.8 Principles of Operation 
The patented design of the CorNeat KPro and the unique implantation procedure include five 
mechanisms which ensure short- and long-term integration, retention, and water tightness (see 
Table 3 below). While short-term water tightness is achieved by mechanical means, long-term 
integration, retention, and water tightness are based on the device’s unique skirt, which is 
implanted subconjunctivally. This porous skirt, made from non-degradable and non-woven 
fibers, extends near the extraocular muscles’ insertions, serving as a scaffold for migration of 

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fibroblasts from Tenon’s capsule (thin membrane enveloping the eyeball from the extraocular 
muscle insertions to the limbus) and subconjunctival fibrous tissue into the skirt of the CorNeat 
KPro. This unique integration concept, which has been validated in multiple animal studies, 
permanently attaches the device to the eye and seals it. Within several weeks, fibroblasts 
colonize the skirt and sprout collagen within it (Figures 8-11).    
Table 3: Short and long-term retention features 
Time of action 
Short term retention 
Water tightness 
Ease of implantation 
Long term retention 
Globe integrity 
Mechanism  
Posterior undercut 
 
 
Posterior flanges 
 
 
3 non-degradable safety 
sutures 
 
 
Bio-integrative porous, 
polymeric skirt 
 
 
5 Bio-integration grooves 
 
 
 
Figure 10: CorNeat KPro skirt laid between the sclera and the conjunctiva 
NZW rabbit histopathology slide showing no inflammation/capsule around the skirt 1- month post 
implantation 
 

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Figure 11: NZW histopathology slide stained with Mason Trichome showing fibroblasts (pink) 
and collagen (blue) within the device's skirt as it is laid between the sclera and the conjunctiva 
 
Figure 12: NZW histopathology slide stained with Mason Trichome 6 months post operation. 
The device’s skirt is fully colonized with fibroblasts (pink) and collagen (purple) 
 
Figure 13: CorNeat KPro integration concept proven in an NZW rabbit (6 months post operation) 
 
The mechanisms that hold the device’s lens in place and seal the eye in the short term enable 
the skirt to integrate. These include the device posterior (corneal) undercut, which hosts the 
recipient corneal stump – a set of flanges on the posterior side mitigating the risk of the stump 
slipping out of the undercut – and 3 sets of non-degradable sutures securing the lens onto the 
sclera. This mechanism, which ensures water tightness, was tested in cadaver eyes and 
validated to withstand an Intra Ocular Pressure (IOP) greater than 3X the upper limit of normal 
IOP, with no leaks. The mechanism is based on the fact that the central cylinder, which 
traverses the native cornea, is larger in diameter than the trephination. The native corneal 
stump, which is pushed against the PMMA cylinder, creates a seal that prevents aqueous 
humor from leaking out. The short-term mechanisms that secure the device into place reduces 
the skirt’s movements and stabilizes it in a way that enables its biological integration (see 
Figures 12-15).  

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Figure 14: CorNeat KPro illustration showing how short-term water tightness is achieved. The 
lens’ cross section shows how the native corneal stump fits into the device’s corneal undercut 
as well as 2 of the 3 non-degradable sutures securing the device onto the sclera. 
 
Figure 15: CorNeat Lens water tightness test performed on cadaver eye 
Intraocular pressure raised to 3X the normal pressure using BSS infusion 
 
In order to further ensure long term retention, the KPro’s PMMA lens is surrounded by a set of 
curved integration holes. These holes are filled with skirt material, which stimulates cellular 
growth and colonization. It is expected that connecting tissue will grow through the holes, thus 
“bio-stitching” the PMMA to the eye wall. This function was validated in animal implantations. 

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Figure
 
16 : CorNeat KPro illustration - blue area represents optics integration rim sandwiched by 
the skirt material 
 
Figure 17: A cross section of the integration rim showing an integration hole filled with the skirt 
material 
4.2.9 Regulatory History 
There is no regulatory history for the CorNeat KPro device and respective implantation kit. For 
the initial indications for use, which are detailed in section 4.2.5, FDA submission will be based 
on guidance on 510(k) submissions for KPros dated March 3, 1999. Product will be classified as 
class II special controls.  
CorNeat Vision does not have regulatory history as all its products are currently in development 
phases. Company products are developed and validated in compliance with relevant standards 
and QMS system is implemented and audited as required.  
5 Study Objectives And Endpoints  
5.1 
Objective 
The objective of this clinical trial is to prove the safety and efficacy of the CorNeat KPro device 
intra and post-operatively. 
 

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5.2 
Endpoints 
5.2.1 Primary Safety Endpoint 
The frequency and severity of all unanticipated adverse device-related events (UADE) or 
treatment-related adverse events, during and after implantation of the CorNeat KPro device up 
to 12 months should be less than SOC (as detailed in section Known Potential Risks).  
5.2.2 Effectiveness Endpoints: 
Primary Effectiveness Endpoint: Device retention   
Secondary Effectiveness Endpoint: Improvement in visual acuity  
6 Study Design 
Prospective, open label, single arm, FIH clinical study to assess Safety and efficacy of the 
CorNeat Keratoprosthesis for the treatment of corneal blindness   
Subjects will be screened by the participating clinical site’s clinical team (physician and study 
staff) during a screening visit. Each subject will sign the ICF (Informed Consent Form) prior to 
any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible 
subjects will be enrolled in the study. Demographic data, medical history and concomitant 
medication use data will be collected from enrolled subjects. Subjects will be implanted with the 
CorNeat KPro,  and followed-up for Ocular wall integrity at the implantation site (primary 
endpoint) and absence of conjunctival irritation at implantation site (secondary endpoint) for 12 
months in 8 clinic visits. During follow up visits safety data and use of concomitant medication 
will be documented. Subjects successfully completing 12 months of follow-up will be monitored 
for device retention and other safety issues during 3 clinic visits spanning an additional 12 
months (not included in the scope of this trial). Subjects accrual is planned for 12 months and 
overall first subject in to last subject out is planned for 24 months.  
Follow up plan will include complete clinical exam, anterior segment photography and a 
questionnaire assessing pain and other possible subjective ramifications. 
7 Study Population and Subject Selection 
7.1 
Study Population 
10 subjects suffering from unilateral or bi-lateral corneal blindness not reasonably amenable by 
transplanting human tissue. The KPro can be implanted in OD or OS (selection is according to 
PI discretion).  

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7.2 
Subject Selection 
7.2.1 Inclusion Criteria 
7.2.1.1 Male or female aged ≥ 18 and ≤ 80 years on the day of screening 
7.2.1.2 Candidates must have the ability and willingness to attend all scheduled visits and 
comply with all study procedures 
7.2.1.3 Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable 
option or following a verifiable history of prior failed corneal transplantation.  
7.2.1.4 Indications that fall under poor candidate for keratoplasty include but are not limited to: 
herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, 
Steven Johnson Syndrome, and limbal stem cell deficiency;  
7.2.1.5 Pseudophakia 
7.2.1.6 Adequate tear film and lid function 
7.2.1.7 Perception of light in all quadrants 
7.2.1.8 Female patients of childbearing age must have negative pregnancy test at screening 
and agree to use an effective method of contraception throughout the study 
7.2.2 Exclusion Criteria  
7.2.2.1 Reasonable chance of success with traditional keratoplasty 
7.2.2.2 Current retinal detachment 
7.2.2.3 Connective tissue diseases 
7.2.2.4 End stage glaucoma 
7.2.2.5 History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) 
in one or both eyes within 6 months prior to planned implantation 
7.2.2.6 History of ocular or periocular malignancy 
7.2.2.7 History of extensive keloid formation 
7.2.2.8 Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or 
component of the device 
7.2.2.9 Signs of current infection, including fever and current treatment with antibiotics 
7.2.2.10 Severe generalized disease that results in a life expectancy shorter than a year 

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7.2.2.11 Any clinical evidence that the investigator feels would place the subject at increased 
risk with the placement of the device 
7.2.2.12 Corneal thickness less than 400 or higher than 1,200 microns in any region of the 
pachymetry map of the eye intended to be operated 
7.2.2.13 Currently pregnant or breastfeeding 
7.2.2.14 Participation in any study involving an investigational drug or device within the past 30 
days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study 
with an investigational drug or device  
7.2.2.15 Intraoperative complication that would preclude implantation of the study device. 
7.2.2.16 Vulnerable populations.  
Subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the 
protocol study and implanted with the CorNeat KPro device. 
7.3 
Informed Consent 
Written informed consent must be obtained for each study subject prior to the commencement 
of the study. The written informed consent (approved by the Institutional Ethics Committee/ 
REB) must be signed and dated by the investigator. A copy of the signed informed consent form 
will be given to the subject. The signed informed consent will be retained with the study records 
at the site. The investigator is responsible for assuring that informed consent is obtained 
regarding each subject in accordance with local guidelines and ISO14155 standard. 
 
7.4 
Replacement of Dropouts 
Subjects have the right to withdraw from the study at any time, for any reason, without 
jeopardizing their medical care. Subjects, who have not completed the 6-month follow-up visit 
and drop out of the study for any reason, may be replaced. Dropouts will be evaluated in the 
Intent to Treat (ITT) Cohort. A separate cohort will exclude these subjects. Every effort will be 
made to determine the reason for the subject dropping out of the study. Where possible, 
subjects will be followed for safety and encouraged to return for follow-up visits for any 
unresolved safety events. 
8 Trial Procedures 
8.1 
Visit Schedule 
8.1.1 Screening and Consent  
Potential participants will be provided with written information about the study describing the 
study, advising them of the study requirements, and possible risks. Study investigators must 

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ensure that potential participants understand the information provided, and review requirements 
and potential risks. Individuals agreeing to participate in the study must sign the informed 
consent form according to local regulations. Upon verification of eligibility and execution of 
informed consent, subjects will be assigned a study code.  
Screening visit will be performed up to 2 weeks before surgery and will include: 
• 
Best Corrected Visual Acuity (BCVA) 
• 
Slit Lamp Examination   
• 
IOP – will be measured either by tactile evaluation or using an appropriate tonometry 
technique 
• 
OCT/UBM imaging 
• 
Pain assessment with visual analogue scale (VAS) 
• 
Concomitant medications 
• 
Women of child-bearing potential must provide a negative pregnancy urine test. 
• 
Subject demographic and medical information acquired from subject's medical file.  
8.1.2 Implantation 
Implantation day will be recorded as day 0; enrolment day   
Safety data will be collected upon enrolment. 
 
Patients will be hospitalized as decided by the surgeon, estimated 1 hospitalization day will be 
required. Patients will be informed that they have the right to contact the PI or designee per their 
discretion 
8.1.3 Operative Evaluation 
During the procedure of each eye, most essential safety parameters, such as collapse and/or 
bleeding of the anterior chamber, iris or lens damage and unusual surgical problems will be 
recorded. Additionally, proper placement of the device's components (i.e. optic and skirt) will be 
confirmed and recorded. 
8.1.4 Procedural Failures 
Failure to perform study device procedure will be recorded in the CRF as an operative failure. 
8.1.5 Post-Operative Supportive Care 
Patients will be prescribed with prophylactic antibiotics and anti-inflammatory medications post 
implantation. Regimen for each medication and/or the addition of medications such as 
hypertension prophylaxis will be decided on a case by case basis and per the investigator’s 
discretion. 
The following options of treatment may be considered: 
• 
A flouroquinolone, preferably 4th generation, should be applied for the first month 
QID(4Xd) 

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If antibiotics are unavailable, 1% povidone iodine 2 to 4 times daily can be used for the 
short-term. 
• 
To control inflammation after KPro implantation, prednisolone 1% drops 2-4x per day for 
the first month are recommended either with or without additional non-steroidal anti-
inflammatory drugs (NSAID) such as Tromethamine. 
Patients will be advised to avoid eye rubbing since infectious or toxic debris may be pushed into 
the eye and will be instructed to wear sunglasses or UV-blocking contact lenses to protect 
against UV induced eye damage. 
8.1.6 Follow Up 
Follow Up- (up to 12 months) visit schedule: One day post op, one week (±2 days) one month (±7 
days), two months (±14 days)  three months (±14 days), six months (±14 days), nine months (±14 
days) and twelve-months (±14 days) post-surgery. 
On each follow-up visit, subjects will be subjected to the following examinations: (i) slit-lamp 
biomicroscopy, (ii) visual acuity (BCVA), (iii) IOP, (iv) concomitant medications record, (v) Pain 
assessment and (vi) Adverse events recording. 
In every follow up visit, IOP will be measured by tactile assessment as follows: Digital palpation 
of the globe will be performed with the patient gently looking down. Palpation directly over a 
glaucoma drainage device plate should be avoided in patients with tubes who should be instructed 
to look in an alternate direction. The eye should then be very gently balloted between the 
surgeon’s two index fingers, as his or her other fingers rest against the face and orbital rim. 
In addition, OCT/UBM imaging will be performed on screening visit, on 1-week post-op and every 
3 months starting at 3 months post-surgery. 
During all study period only safety data (i.e. possibly related or related AEs, SAEs, UADE) will 
be collected in the eCRF for visits performed outside of protocol visits timetable. 

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8.2 
Table Of Assessment 
Assessments/Procedur
es 
Screening  
Proce
dure 
Follow-up (time post surgery)  
 
Time in study 
-14 to -0 
0 
1 
day  
1 week   
±2 days  
1 month 
±1 week 
2 months 
±2 weeks 
3 months 
±2 weeks 
6 Months 
±2 weeks 
9 Months 
±2 weeks  
12 months 
±2 weeks 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Inclusion /exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
Medical history, 
Demographic, pregnancy 
test (women of child-
bearing potential only) 
X 
 
 
 
 
 
 
 
 
 
CorNeat KPro device 
implantation 
 
X 
 
 
 
 
 
 
 
 
Slit Lamp Examination, 
BCVA, IOP  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
OCT/UBM imaging 
X 
(Anterior) 
 
 
X 
(RNFL) 
 
 
X 
(RNFL) 
X 
(RNFL) 
X 
(RNFL) 
X 
(RNFL) 
Pain Assessment  
(Visual analogue scale-
VAS)  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
AE/SAE/UADE 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Only safety data will be collected in CRF for Post hospitalization period and visits performed between protocol scheduled visits (i.e., 
related or possibly related AE, SAEs, UADE)  

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9 Training 
CorNeat KPro implantation will be performed only by ophthalmic surgeons which are well 
trained in corneal surgery specifically keratoprosthesis implantations. Each ophthalmologist will 
be trained by implanting the CorNeat KPro implant in ex-vivo animal eyes prior to subject 
enrollment. Prior to the wet lab training, a presentation outlining the procedural step with an in-
depth discussion on the unique aspects of the device and procedure will be conducted. The 
Investigator formal training will be performed by the study sponsor prior to subject enrolment at 
the study center. Training certificate will be issued to investigators who successfully passed the 
wet lab. 
10 Safety Parameter 
 
10.1 
Adverse Event Definition  
An adverse event is any undesirable or unintentional event that occurs during the course of the 
study, whether or not considered related to the device. Regardless of severity or relationship to 
the investigational device, all adverse events occurring during the study must be recorded in the 
subject’s CRF  
All adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA, most updated version) terminology and presented in tables by System Organ Class 
(SOC) and Preferred Term (PT).  
AE data will be listed individually and summarized by SOC and by PT within a system organ 
class. 
Additional tables will present adverse events by PT, SOC and severity and by relatedness to 
study device.   
10.2 
Severity of an Adverse Event 
Mild Adverse Event 
A mild adverse event is one that its symptoms are barely noticeable to the subject.  It does not 
influence performance, require drug treatment or prevent the subject from carrying on with 
normal life activities. 
Moderate Adverse Event 
A moderate adverse event is one that its symptoms make the subject uncomfortable and 
causes some impairment to normal life activities.  Treatment for the symptom(s) may be 
required. 
Severe Adverse Event  
A severe event is one in which the symptoms cause severe discomfort to the subject and limits 
the subject’s normal life activities.  Treatment for the symptom(s) may be required . 
 
 
 

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10.3 
Relationship to Study Device 
The following definitions will be used to assess the relationship between an adverse event and 
the investigational device. 
Not Related 
The event is clearly related to other factors such as the subject's clinical state, therapeutic 
interventions or concomitant drugs. 
Possibly Related 
The event has a reasonable temporal relationship to the use of the investigational device and 
follows a known response pattern to the investigational device.  However, a potential alternate 
etiology may be responsible for the event.  The effect of device withdrawal is unclear.  Re-
challenge information is unclear or lacking. 
Related 
The event follows a temporal sequence from the time of use of the device and follows a known 
response pattern to the investigational device and either occurs immediately following 
investigational device use, or improves on stopping the use of the device, or reappears on 
repeat exposure to the device. 
 
10.4 
Serious Adverse Event Definition 
 
A serious adverse event is an event that is: (a) fatal, (b) life-threatening (c) results in persistent 
or significant disability/incapacity (d) requires or prolongs in subject hospitalization or (e) leads 
to a congenital anomaly or birth defect.  
Life threatening is defined as an event in which the subject is at risk of death at the time of the 
event.  It does not refer to an event that hypothetically might have caused death if it was more 
severe.   
Disability is defined as a substantial disruption of a person’s ability to conduct normal life 
functions.   
An unexpected adverse event is one that has not been previously observed or one that is a 
specificity or severity not consistent with the current investigator brochure. 
All pre-existing medical conditions will be recorded on medical history or physical exam case 
report forms.  
Hospitalization or prolonged hospitalization for diagnostic or elective procedures for pre-existing 
conditions will not be considered as SAE. Exceptions of adverse device effects are changes 
related to the underlying disease or medical conditions that are consistent with expected 
disease progression and will not be considered adverse device effects in this study. 
10.5 
Unanticipated Adverse Device-related Event Definition 
An unanticipated adverse device-related event is any serious adverse effect on health or safety, 
any life-threatening problem or death caused by, or associated with a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in 
section Known Potential Risks. 
 
 

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10.6 
Adverse Event Reporting  
When an adverse event occurs, the following information and assessments in the adverse event 
section of the CRF will be recorded:  
• 
The signs, symptoms or diagnosis of the event 
• 
The date and time of onset and termination of the event (24-hours clock format where          
midnight is 00:00 and noon is 12:00) 
• 
The adverse event severity using the criteria outlined above 
• 
The relationship of the event to the investigational device as outlined above 
• 
A description of any action taken regarding study device disposition  
• 
A list of any required therapy, medication, treatment or diagnostic procedure 
• 
Clinical behavior prior to the event, such as nutrition, medicine, physical activity etc. 
• 
Any additional data which might be relevant to the event  
The investigator is responsible for the appropriate medical management of all adverse events 
and for the personal safety and well-being of the subjects.   
10.7 
Serious Adverse Events Reporting and Unanticipated Adverse Device-Related 
Events (UADE) 
Any serious and/or unexpected and/or device related adverse event must be reported to the 
sponsor- CorNeat Vision and the Clinical Study Monitor via the EDC system. Full details of the 
event, treatment, and an assessment of the relationship between the investigational device 
must be provided in the report. The report shall be prepared by the principal investigator.  
Reports relating to the subject’s subsequent medical course must be submitted to the sponsor 
until the event has subsided or, in case of permanent impairment, until the event stabilizes, and 
the overall clinical outcome has been ascertained. 
CorNeat Vision will notify all investigators in writing of severe/serious or unexpected adverse 
events when this information is of global importance to subject safety and welfare. 
Reporting to the EC/REB will be done according to local regulation.  
 
 

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10.8 
Known Potential Risks 
Known risks from usage of similar artificial corneas are: 
• 
Postoperative Corneal Melt - is one of the most severe complications that can occur 
after keratoprosthesis surgery with incidence of up to 30%6,7,8. It may lead to scarring, 
irregular astigmatism, photophobia, decreased vision, and even endophthalmitis. 
• 
Lack of graft retention - Corneal grafts tissue artificial integration is limited and with time 
the bond between the implant and eye weakens. E.g. Boston KPro’s retention rates 
decreases over time with incidence of lack of retention of 6, 11 and 25% after 1, 2- and 
5-years post-op, respectively9,10. 
• 
Post-operative Glaucoma - is the most important threat to long-term preservation of 
vision following Boston KPro surgery with elevation of intraocular pressure in 19–38 % of 
patients postoperatively and progression of pre-operative glaucoma in 7–14 % of 
patients. Development of glaucoma de novo following Kpro placement has been 
reported in 2-28% of KPro recipients 11,12,13,14,15. 
• 
Poor post-operative visual quality - Eyes with current KPros have very limited visual field 
and poor visual function. About 50% of patients implanted with Boston KPro maintain 
20/200 CDVA after 8 years from surgery 16,17.  
 
6 Bouhout, S., Robert, M.C., Deli, S. and Harissi-Dagher, M., 2018. Corneal melt after Boston keratoprosthesis: Clinical 
presentation, management, outcomes and risk factor analysis. Ocular immunology and inflammation, 26(5), pp.693-
699. 
7 Schaub, F., Bachmann, B.O., Seyeddain, O., Moussa, S., Reitsamer, H.A. and Cursiefen, C., 2017. Mid-and longterm 
experiences with the Boston-keratoprosthesis. The Cologne and Salzburg Perspective. Klinische Monatsblatter fur 
Augenheilkunde, 234(6), p.770. 
8 Jin, B. and Zhu, X., 2017. The pathogenesis and prevention of corneal graft melting after keratoplasty. J Clin 
Ophthalmol, 1(1), p.10. 
9 Ciolino, J.B., Belin, M.W., Todani, A., Al-Arfaj, K., Rudnisky, C.J. and Boston Keratoprosthesis Type 1 Study Group, 
2013. Retention of the Boston keratoprosthesis type 1: multicenter study results. Ophthalmology, 120(6), pp.1195-
1200. 
10 Kang, K.B., Karas, F.I., Rai, R., Hallak, J.A., Kang, J.J., de la Cruz, J. and Cortina, M.S., 2018. Five year outcomes 
of Boston type I keratoprosthesis as primary versus secondary penetrating corneal procedure in a matched case 
control study. PloS one, 13(2). 
11 Vora, G.K. and Colby, K.A., 2012. Management of glaucoma following Boston keratoprosthesis. Eur Ophthal Rev, 6, 
pp.214-217. 
12 Chew, H.F., Ayres, B.D., Hammersmith, K.M., Rapuano, C.J., Laibson, P.R., Myers, J.S., Jin, Y.P. and Cohen, E.J., 
2009. Boston keratoprosthesis outcomes and complications. Cornea, 28(9), pp.989-996. 
13 Netland, P.A., Terada, H. and Dohlman, C.H., 1998. Glaucoma associated with keratoprosthesis. Ophthalmology, 
105(4), pp.751-757. 
14 Greiner, M.A., Li, J.Y. and Mannis, M.J., 2011. Longer-term vision outcomes and complications with the Boston type 
1 keratoprosthesis at the University of California, Davis. Ophthalmology, 118(8), pp.1543-1550. 
15 Sayegh, R.R., Ang, L.P., Foster, C.S. and Dohlman, C.H., 2008. The boston keratoprosthesis in Stevens-Johnson 
syndrome. American journal of ophthalmology, 145(3), pp.438-444. 
16 Aravena, C., Yu, F. and Aldave, A.J., 2018. Long-term visual outcomes, complications, and retention of the Boston 
type I keratoprosthesis. Cornea, 37(1), pp.3-10. 
17 Lee, R., Khoueir, Z., Tsikata, E., Chodosh, J., Dohlman, C.H. and Chen, T.C., 2017. Long-term visual outcomes and 
complications of Boston keratoprosthesis type II implantation. Ophthalmology, 124(1), pp.27-35. 

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Additionally, in eyes with Boston KPro, the visual field is estimated at approximately 40-45° of 
half-luminance field which is usually used to estimate the visual field through a device18.  
• 
Intra-operative suprachoroidal hemorrhage and vitreous prolapse - Conventional 
penetrating keratoplasty (PK) and current KPro procedures are performed after the 
cornea has been removed from the eye – aka “open-sky”. Open sky procedures entail 
high risk of expulsive suprachoroidal hemorrhage and vitreous prolapse19. 
• 
Retro-KPro membranes (RPM) formation- are the most common complication in KPro 
implanted patients, with an incidence of 27-47.6%.  
RPM is usually treated with Nd:YAG membranotomy which can cause retinal 
detachment in 26.7%20. 
• 
Endophthalmitis - The incidence of endophthalmitis in KPro patients is relatively high 
(1.2-11.4%) even in patients with prophylactic antibiotic topical treatment20. 
Other risks include: 
• 
Transient inflammatory reaction around the eye 
• 
Vitreous hemorrhage- bleeding inside the eye 
• 
Vitritis- sterile inflammation inside the eye 
• 
Retinal Detachment- separation of the retina from the wall of the eye resulting in loss of 
vision 
• 
Ptosis- a droopy eyelid 
• 
Foreign body sensation 
10.9 
Device Explantation 
10.9.1 Potential Clinical Scenarios Resulting in Device Explantation 
Potential clinical scenarios resulting in the removal of the CorNeat KPro can be attributed to the 
following three pathological processes: 
• 
Severe retroprosthetic membrane (RPM) formation - Most RPMs are typically treated 
with neodymium:yttrium-aluminum-garnet (Nd:YAG) laser membranotomy or by surgical 
membranectomy. However, when an aperture cannot be created in the membrane with 
either method, the keratoprosthesis should be replaced. 
• 
Infection – may occur due to bacterial, viral, fungal or parasitic pathogens that entered 
the eye. This will be prevented using prophylactic use of antibiotics and intra-surgical 
antiseptic technique. In the case of an active infection in the eye, the ophthalmologist will 
opt for urgent intervention to retrieve a specimen for cultures and to inject potent 
 
18 Sayegh, R.R., Diaz, L.A., Vargas-Martín, F., Webb, R.H., Dohlman, C.H. and Peli, E., 2010. Optical functional 
properties of the Boston keratoprosthesis. Investigative ophthalmology & visual science, 51(2), pp.857-863. 
19 Chen, W., 2015. Innovative Method to Avoid the Open-Sky Condition in Penetrating Keratoplasty and the Triple 
Procedure: Securing the Anterior Chamber. Cornea, 34, p.S113. 
20 Cortina, M.S. and de la Cruz, J., 2015. Keratoprostheses and Artificial Corneas. Fundamentals and Surgical 
Applications, p.2015. 

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antibiotics intravitreally. Endophthalmitis patients may also require an urgent surgery 
(pars plana vitrectomy), and evisceration may be necessary to remove a severe and 
intractable infection which could result in a blind and painful eye. 
• 
Tissue necrosis - can result in corneal perforation, hypotony, and / or instability, leading 
to extrusion of the device. Based on the severity and specific circumstances of each 
case, the surgeon may decide either to replace the CorNeat KPro with another artificial 
cornea, seal the eye with a donor cornea or perform an evisceration or enucleation 
procedures. 
10.9.2 Device Explantation Procedure 
Upon reaching the decision to remove the device, the surgeon may choose one of the following 
surgical approaches according to the specific ocular condition and per his/her discretion: 
1) Releasing the skirt component from under the overlying conjunctiva using sharp dissection. 
2) Removal of only the optic component of the CorNeat KPro while the skirt component 
remains under the overlying conjunctiva. This will be performed by cutting the skirt around 
the optic componenet with an appropriate blade or scissors throughout the entire 
circumference.  
The eye will be implanted with either a replacement CorNeat KPro, tectonic corneal graft or an 
alternative artificial cornea. 
It should be noted that in severe cases of the above-mentioned complications, evisceration or 
enucleation might be the only options remaining. 
10.10 
DSMB 
The ten first implanted subjects will comprise the first-in-human cohort. Once the 10th subject 
successfully completes the 6th month post-surgery follow-up, an independent data-safety-
monitoring-board (DSMB) will review the data and submit its conclusions to the study sponsor. 
Copies will be forwarded to the REB and to the Ministry of Health. 
In order to manage the FIH cohort for DSMB submission participating sites will inform sponsor 
upon subject screening via subject screening log.   
10.11 Premature Termination or Suspension of the Study 
The trial will be stopped if severe side effects or infections, resulting in device removal and 
related with the investigational device, are diagnosed in three patients. 
In case of premature termination of the study, the PIs will decide regarding the required future 
follow up for each patient on a case by case basis. 
The trial may be temporarily suspended if there is sufficient reasonable cause.  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 

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• 
Demonstration of poor efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
If the study is suspended, the PIs will promptly inform the EC and will provide the reason(s) for 
the suspension. Study may resume once concerns about safety, protocol compliance, and data 
quality are addressed and satisfy the sponsor, EC, and /or respective regulatory agency. 
11 Insurance 
The sponsor will appropriately ensure the study; trial will be covered in accordance to medical 
centers requirements and local regulation.  
12 Data Collection, Processing and Statistical Analysis 
12.1 
Data Collection and Processing 
12.1.1 Subject Data Protection 
Investigators are responsible for keeping a list of all subjects, including subject numbers, full 
names and last known addresses, identification log. Throughout the study, all collected data will 
be identified by subject number only and kept in accordance with local data protection 
requirements and with regulation (EU) 2016/679 of the European parliament and of the council 
of 27 April 2016 on the protection of natural persons with regard to the processing of personal 
data and on the free movement of such data and repealing Directive 95/46/EC (General Data 
Protection Regulation) GDPR. 
12.2 
Statistical Analysis and Sample Size 
12.2.1 Sample Size Consideration 
The rationale for the sample size of 10 subjects for this FIH trial is based on regulatory 
requirements set down by the FDA in the Keratoprosthesis 510K guidance document and on a 
clinical trial for corneal blindness using a KPro- trial number NCT03126903 running currently (A 
Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity). In 
the KearKlear FIH trial 15 patients were included and followed up for 7-21 months.21 The FDA 
510k demands 20 patients followed up for approximately one year. (press here for the FDA 
protocol) 
 
7 A new epidescemetic keratoprosthesis: pilot investigation and proof of concept of a new alternative 
solution for corneal blindness.Br J Ophthalmol. 2015 Nov;99(11):1483-7. doi: 10.1136/bjophthalmol-
2014-306264. Epub 2015 Apr 13.Alio JL, Abdelghany AA, Abu-Mustafa SK, Zein G. 
 

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12.2.2 Sample Size Justification 
Reference to FDA guidance for Keratoprosthesis 510K where proving safety is the target and 20 
subjects with a minimum of 330 days of follow up is needed. 
12.2.3 Statistical Analysis 
There is not a separate Statistical Analysis Plan (SAP) document in use for the trial since no 
statistical methods are applied in this study. 
The safety analysis set will consist of all patients who were enrolled into the study. Individual 
listings of adverse events including adverse events (reported term), duration, relationship to the 
study device, severity and the adverse events outcome will be provided for the total population, 
where applicable. AEs will be summarized using frequency counts and percentages. 
12.3 
Monitoring Procedures 
The investigational site will be monitored periodically to assure satisfactory subject enrollment, 
data recording, and protocol adherence. Study monitoring functions will be performed by 
CorNeat Vision in compliance with recognized Good Clinical Practices (GCP), ISO 14155 
standard. In addition to ensuring adequate communication between the investigators and the 
sponsor, the monitor’s duties include on-site visits, participation in the initial implantations and 
follow up visits of the device, and review of the study documents and results. The monitor, as 
well as inspectors and auditors, must have direct access to all relevant source documents. The 
investigator and staff are expected to cooperate with the study monitor and provide to the study 
monitor all relevant study documentation.  It is essential that the investigator and study 
coordinator set aside a sufficient amount of time for these visits to permit an adequate review of 
the study’s progress and of completed case report forms. 
12.3.1 On-Site Monitoring 
On-site monitoring visits include a pre-study visit, periodic visits during the course of the 
investigation, and a final “close-out” visit at the conclusion of the study. The frequency of 
monitoring may vary depending on enrollment rate and the quantity of data collection. At the 
pre-study visit, the monitor will meet with the Principal Investigator and discuss the protocol’s 
contents, study requirements and related staff requirements.  The monitor will also evaluate the 
suitability of the premises for record keeping, regulatory requirements, logistic procedures, 
availability of suitable source documentation forms, etc.  At the pre-study visit, the monitor will 
specifically verify that the investigator: 
Has appropriate training, facilities, subject load, time, and willingness to comply with study 
requirements; 
• 
Has all study documentation and required records on site; and 
• 
Assumes responsibility for the investigation at his/her center. 
Subsequent to the pre-study visit, the monitor will continue to conduct on-site visits to monitor 
the study’s progress.  These periodic visits are intended to assess the investigator’s adherence 

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to the Investigational Protocol, maintenance of records, reports, and investigational devices, and 
review of source documents for accuracy, completeness, and legibility.  During these periodic 
visits, the monitor is required to assess the progress of the study toward meeting its objectives, 
and to identify any concerns from observations of device performance and/or review of the 
investigator’s subject records, study management documents, and informed consent 
documents, and to ensure accountability of all subjects that have been treated under the study.  
The monitor’s final on-site visit at the completion of the study is intended to assure that all the 
data have been properly completed and to have a closing meeting with the investigator and 
his/her staff members. 
Reports of the on-site visits will be made by the monitor and will include resolution of concerns, 
completion of appropriate follow-up activities, completion of assigned tasks, and any necessary 
corrective actions.  At the close of the study, the monitor will prepare a final report according to 
local regulation. Upon Ethics committee /REB approval of the Final Report, a close-out visit will 
be performed to ensure that all relevant documentation is filed and archived according to 
regulations under the investigator’s responsibility and unused study device returns to sponsor. 
12.4 
Study Site Initiation 
An initiation meeting will take place at which all procedures will be explained to all staff involved 
in the study to ensure understanding of the study requirements prior to initiation of study 
procedures. 
 
12.5 
Protocol Changes or Amendments 
 
The principal investigator agrees not to make any changes to the investigational study protocol 
or its conduct except when necessary to eliminate immediate hazards to human life. 
Changes in the investigational study protocol may be made only by written amendment by 
CorNeat Vision. Protocol amendments must be approved by the EC/REB prior to 
implementation. Documentation of approval for such amendments must be kept on file by the 
investigator and forwarded to CorNeat Vision. 
12.6 
Case Report Forms (CRF) 
The data collected by the eCRF will be accumulated in an Electronic Data Capture (EDC) 
system database. Data will be entered by study staff during the study and at its conclusion by 
data management personnel corresponding with the study monitor and site investigators. It will 
be collected by data improvement through queries, which is automatic using the system’s edit 
checks while data is typed in, and manually following source data verification (performed at 
monitoring visits). The EDC system will be in compliance with GCP and with Directive 95/46/EC 
of the European Parliament and of the Council of 24th of October 1995 on the “Protection of 
individuals with regard to the processing of personal data and on the free movement of such 
data”. 

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BE REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT PRIOR WRITTEN CONSENT. 
Page 40 of 41 
 
12.7 
Maintenance of Study File 
Study records including subject source documents, case report forms, all test results and signed 
informed consent forms must be kept on file by the investigator. All Ethics Committee 
correspondence including notification of protocol and consent form approval and all annual 
reports along with the final report to the Ethics Committee must be retained.  Other documents 
pertaining to the conduct of the study including laboratory normal values, laboratory certification, 
monitor correspondence and all other relevant written correspondence must also be kept as part 
of the permanent record. Records must be retained for at least 15 years and in accordance to 
local regulation. 
Should storage no longer be available to archive source document or must be move to an 
alternative location, the research staff should notify the key sponsor contact prior to document 
shipping.   
12.8 
Device Accountability  
On site study device will be kept in a secure location with restricted access. The study devices 
will be handled by trained personnel. The Investigator will not supply the study device to any 
individual not involved in the investigation. The study device will be inventoried at regular 
intervals during the study, and all unused devices will be returned to the CorNeat Vision when 
study enrolment is closed. 
12.9 
On-Site Audits 
Authorities may request access to all study records, including source documents for inspection.  
The principal investigator and staff are requested to cooperate with all such audits.  The 
principal investigator must notify CorNeat Vision of any audit as soon as possible. A 
representative or designee of CorNeat Vision’s clinical or regulatory department may also 
conduct similar auditing procedures and may be present during any outside audit or Inspection.  
12.10 
Reports 
Periodic status reports will be submitted at least yearly or according to local regulation to the 
EC/REB and according to local regulation. Within 6 months after completion or termination of 
the study, a final report must be submitted to the EC/REB.  The investigator must maintain an 
accurate and complete record of all submissions made to the EC/REB. 
 
12.11 
Disclosure and Publication of Information 
All proprietary information including; CorNeat Vision’s operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formulation information provided to the 
investigator or the methodologies used in this study, as well as proprietary information obtained 
during the course of the study are confidential and will remain the sole property of CorNeat 

CorNeat KPro - Clinical Investigational Protocol 
 
UNCONTROLLED WHEN PRINTED 
CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION. THIS DOCUMENT MAY NOT 
BE REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT PRIOR WRITTEN CONSENT. 
Page 41 of 41 
 
Vision. The investigator agrees not to disclose any proprietary information supplied by CorNeat 
Vision in any way without prior written permission.  
Individual subject data obtained during this study are confidential and will not be disclosed to 
third parties with the following exceptions: when the data is needed by the subject’s personal 
physician or other medical personnel responsible for the subject’s welfare. For data inspection 
and verification by CorNeat Vision or designate, regulatory authority auditors or by the 
Institutional EC.