Evaluating the Use of Eye-tracking Technology in the Diagnosis of Neurological Patients, Including Patients With Reduced Consciousness
Conditions: Postcomatose Unawareness State, Minimally Conscious State, Vegetative State, Disorder of Consciousness, Post-Traumatic Coma, Neurological Injury, Traumatic Brain Injury, Diagnosis, Cognitive Dysfunction, Neurological Disease
Sponsor: AssisTech Sp. z o.o.

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Study protocol 
 
Study Title: 
Evaluating the use of eye-tracking technology in the diagnosis of neurological 
patients, including patients with reduced consciousness 
 
Internal Reference No: C-EYE_DIAGNOSIS_X001 
Ethics Ref: 11/2022 (Commission resolution of 28.03.2022) 
 
Primary Investigator: 
Dr. habil Grzegorz Zurek, Professor of the 
Wroclaw University of Health and Sport 
 
…………………………………………… 
signature 
Research Team (at the Facility): 
 
Sponsor: 
AssisTech Sp. z o.o. 
 
The study was carried out within the framework of the National Centre for Research and 
Development competition 2/1.1.1/2020 grant application number: POIR.01.01.01-00-2125/20. 
 
Confidentiality Statement 
This document contains confidential information. It must not be disclosed to anyone other than the 
Sponsor, the Research Team, the supervising institution, and members of the Research Ethics 
Committee. 
 
 

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Table of Contents 
1. 
SYNOPSIS / Study outline ............................................................................................................ 4 
2. 
BACKGROUND AND RATIONALE ......................................................................................... 5 
3. 
OBJECTIVES ................................................................................................................................ 7 
3.1. 
Primary Objective .................................................................................................................... 7 
3.2. 
Secondary Objectives .............................................................................................................. 7 
3.3. 
Exploratory objective ............................................................................................................... 7 
4. 
STUDY DESIGN ............................................................................................................................ 7 
4.1. 
Primary and Secondary Endpoints ........................................................................................... 8 
4.2. 
Study Participants .................................................................................................................... 9 
4.2.1. 
Overall Description of Study Participants ....................................................................... 9 
4.2.2. 
Inclusion Criteria of study participants / Kryteria włączenia uczestnika badania ........... 9 
4.2.3. 
Exclusion Criteria .......................................................................................................... 10 
5. 
COURSE OF STUDY .................................................................................................................. 10 
6. 
SITE SELECTION: ..................................................................................................................... 11 
7. 
STUDY PROCEDURES ............................................................................................................. 12 
8. 
INFORMED CONSENT ............................................................................................................. 13 
9. 
SCOPE OF DATA COLLECTION ........................................................................................... 14 
10. RANDOMISATION AND CODEBREAKING (if applicable) ................................................ 14 
11. SUBSEQUENT ASSESSMENTS / Kolejne oceny .................................................................... 14 
12. DEFINITION AND END OF STUDY ....................................................................................... 15 
13. DISCONTINUATION / WITHDRAWAL OF PARTICIPANT FROM STUDY ................. 15 
14. SOURCE DATA .......................................................................................................................... 15 
15. DESCRIPTION OF MEDICAL DEVICE ................................................................................ 15 
16. SAFETY REPORTING AND DEFINITIONS ........................................................................... 18 
16.1. Adverse Event (AE) .................................................................................................................. 18 
16.1.1. 
Adverse Device Effect (ADE) ....................................................................................... 18 
16.1.2. 
Serious Adverse Event (SAE) ........................................................................................ 19 
16.1.3. 
Serious Adverse Device Effects (SADE) ....................................................................... 19 
16.1.4. 
Unanticipated Adverse Device Effect (UADE) ............................................................. 20 
16.1.5. 
Serious Unanticipated Adverse Device Effect (SUADE) .............................................. 20 
16.2. Reporting of AE ..................................................................................................................... 20 
16.3. Annual Reports ...................................................................................................................... 20 
17. STATISTICS ................................................................................................................................ 20 
17.1. Description of Statistical Methods ......................................................................................... 21 
17.2. The Number of Participants ................................................................................................... 23 
17.3. The Level of Statistical Significance ..................................................................................... 23 

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17.4. Procedure for Accounting for Missing, Unused, and Spurious Data ..................................... 23 
17.5. Procedures for Reporting any Deviation(s) from the Original Statistical Plan ...................... 23 
17.6. Inclusion in Analysis ............................................................................................................. 23 
18. ACCESS TO SOURCE DATA/DOCUMENTS ........................................................................ 23 
19. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES ............................. 23 
20. ETHICS ........................................................................................................................................ 24 
20.1. Approvals ............................................................................................................................... 24 
20.2. Participant Confidentiality ..................................................................................................... 24 
21. DATA HANDLING AND RECORD KEEPING ...................................................................... 24 
22. FINANCING AND INSURANCE .............................................................................................. 24 
23. PUBLICATION POLICY ........................................................................................................... 24 
APPENDIX A: SCHEDULE OF PROCEDURES ............................................................................ 25 
APPENDIX B: C-Eye X TEST RESULTS TABLES ....................................................................... 26 
Appendix 1 ............................................................................................................................................ 27 
Appendix 2 ............................................................................................................................................ 32 
 
 
 

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1. 
SYNOPSIS / Study outline 
 
Study title 
Evaluating the use of eye-tracking technology in the diagnosis of 
neurological patients, including patients with reduced consciousness 
Justification 
of Tests 
Currently, the diagnostics of consciousness disorders in people who suffer 
severe brain damage is based on standardised behavioural assessment. 
However, behavioural diagnostics often fails because of the severe cognitive, 
sensory and motor deficits associated with impaired consciousness, or 
because of the heterogeneous etiology and pathophysiology associated with 
the condition. Diagnosing consciousness disorders is based on traditional 
psychological and psychiatric tests, which require verbal contact with the 
patient. The use of the visual communication channel in assessing the state of 
consciousness and diagnosing cognitive function seems perfect for patients 
who are unable to communicate verbally and lack the motor skills to 
communicate their needs to medical personnel and their caregivers. Recently 
published studies conducted with patients with disorders of consciousness 
using the eye tracking device, C-Eye, as an alternative communication tool, 
indicate its diagnostic potential for people with this condition. 
Type of clinical 
trial 
Observational study of a medical device after CE authorisation. 
Participants 
of Tests 
Brain-damaged neurological patients with communication barriers, diagnosed 
as being in unresponsive wakefulness syndrome (UWS) or minimal 
consciousness state (MCS), for whom sight may be the only route of 
communication. 
Expected 
number 
of Study 
participants 
The number of observations to be analysed in Poland and Germany 
combined is: 90 
Planned sample 
size 
90 (2 x 45), where 45 – sample size for each Test: 
(Test 1 (MCSD): Minimum Awareness Detection, Test 2 (CFA): Cognitive 
Function Assessment) 
Follow-up 
duration 
No further follow-up of patients is planned. 
Planned Study 
period 
Total duration: 11 months: May 2022 - March 2023  
Phase 1: Preparation for the Study: 2 months: May - June 2022  
Phase 2: Observation study: 7 months: July 2022 - January 2023 
Phase 3: Closing the Study: 2 months: February - March 2023 
Primary 
objective of the 
Study 
Evaluation of C-Eye X system application in the neurological diagnostics of 
patients with reduced consciousness. 

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Secondary 
objective of the 
Study 
Comparing the results of C-Eye diagnosis with those obtained from 
commonly used behavioural and psychological scales in the evaluation of 
patients with reduced consciousness. 
Exploratory 
aim 
Demonstrating that diagnostics of the state of consciousness and cognitive 
function of patients with consciousness disorders performed using C-Eye X 
allows a more objective assessment of the condition of patients who, 
according to traditional methods, remain in no contact with the surrounding 
world. 
Primary 
endpoint 
Obtaining reliable clinical data confirming the diagnosis of the state of 
consciousness and cognitive function of patients with reduced 
consciousness, in whom the diagnostic tool developed during the project 
was applied. 
Secondary 
endpoint 
Evaluation of differences between the results of the state of consciousness 
and cognitive functions of patients with reduced consciousness obtained by 
behavioural methods and using C-Eye X 
Device 
name 
C-Eye X 
Manufacturer 
AssisTech Sp. z o.o. 
Main 
application 
Eye tracking in the diagnostics of consciousness disorders and cognitive 
functions of people with reduced consciousness and communication barriers. 
Duration of 
device use to 
date (years) 
7 years 
 
2. 
BACKGROUND AND RATIONALE  
The diagnostics of consciousness disorders in people who suffered severe brain damage is 
based on standardised behavioural assessment. However, behavioural diagnostics often fails 
because of the severe cognitive and motor deficits associated with impaired consciousness, or 
because of the heterogeneous etiology and pathophysiology associated with the condition. The need 
for an accurate diagnosis and prognosis goes beyond the needs of the patients themselves, as their 
care is associated with a significant stress burden, mainly due to the high uncertainty of the 
prognosis. Currently, the diagnosis of consciousness disorders and cognitive functioning is based 
on traditional psychological and psychiatric tests that require verbal contact with the patient. The 
use of the visual communication channel in diagnosis of the state of consciousness and cognitive 
function seems perfect for patients who are unable to communicate verbally and lack the motor 
skills to communicate their needs to medical personnel and their caregivers. 

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Studies published in recent years using the C-Eye eye-tracking device as an alternative 
communication tool among patients with disorders of consciousness indicate its diagnostic potential 
in this condition. A definite advantage of using the C-Eye system in this context is that the patient 
with reduced consciousness makes the decision to cooperate on their own. C-Eye is further 
characterised by non-invasiveness, adaptation to the neurological patient with visual and cognitive 
deficits, and easy and intuitive operation by the examiner-diagnostician. 
The project will be implemented in a group of patients who, as a result of various causes (e.g. 
trauma, stroke, hypoxia), have suffered brain damage resulting in a significantly reduced state of 
consciousness, unable to communicate other than by eye movement (visual channel). The project 
will use the C-Eye X device, which is the next generation of the previously used C-Eye PRO system. 
Previous publications in this area indicate that, despite significant deficits in the level of 
consciousness or cognitive function, such patients are able to establish communication by sight, and 
their memory or linguistic functions remain at a high level, allowing conscious communication 
using their sight. 
Participation in the project poses no risk to the patient. The tasks that will be performed are not 
taxing on their functioning, nor do they carry the risk of impairing their health. 
The team’s research to date in the field covered by the project has been published in the 
following journals: 
1) Kujawa K., Żurek A., Gorączko A., Olejniczak R., Zurek G.: Monitoring eye movements 
depending on the type of visual stimulus in patients with impaired consciousness due to 
brain 
injury. 
Int. 
J. 
Environ. 
Res. 
Public 
Health 2022, 19(10), 
6280; https://doi.org/10.3390/ijerph19106280  
 
2) Kujawa K, Zurek G, Kwiatkowska A, Olejniczak R, Zurek A: Assessment of language 
functions in patients with disorders of consciousness using and alternative communication 
tool. Frontiers in Neurology, 20 July 2021 https://doi.org/10.3389/fneur.2021.684362 
3) Kujawa K., Żurek A., Gorączko A., Olejniczak R., Żurek G.: Implementing new technologies 
to improve visual-spatial functions in patients with impaired consciousness. International 
Journal of Environmental Research and Public Health, 2022: vol. 19, nr 5, art. 3081. 
https://doi.org/10.3390/ijerph19053081 
4) Kujawa K, Żurek A, Gorączko A, Zurek G. Application of high-tech solution for memory 
assessment 
in 
patients 
with 
disorders. 
Frontiers 
in 
Neurology, 
31 
March 
2022  https://doi.org/10.3389/fneur.2022.841095  

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3. 
OBJECTIVES  
The aim of this Study is to perform a clinical evaluation of the authors’ original battery of 
diagnostic tests in the C-Eye X system, addressed to patients who have suffered damage to the 
central nervous system (CNS) and communicate with the help of the organ of sight (a test to 
differentiate patients’ state of consciousness and a test to assess the level of cognitive function in 
patients), as well as to evaluate the proposed diagnostic method (procedure) (including the type and 
scope of diagnostic tasks and how diagnostic observation is carried out using the C-Eye X system). 
The intention of the project’s authors is to introduce a novel diagnostic solution that will help reduce 
misdiagnoses (currently believed to be up to 40% of errors) made for such patients, due to the 
inadequacy of current behavioural tools to work with patients after severe brain damage. 
3.1.Primary Objective 
Evaluation of the application of the C-Eye X system (proprietary diagnostic tests – MCSD and 
CFA and eye tracking technology) in the neurological diagnosis of patients with reduced 
consciousness. 
3.2. Secondary Objectives 
Comparing the results of C-Eye diagnosis with those obtained from commonly used 
behavioural and psychological scales in the evaluation of patients with reduced consciousness. 
3.3.Exploratory objective  
Demonstrating that diagnostics of the state of consciousness and cognitive function of patients 
with consciousness disorders performed using C-Eye X allows a more objective assessment of the 
condition of patients who, according to traditional methods, remain in no contact with the 
surrounding world. 
4. 
STUDY DESIGN 
The Study will be conducted as an open-label Study..   
After meeting the inclusion criteria, the patient will begin participation, which will last up to 
15 days (one test) or up to 30 days (two tests) per patient. Patients can be added at different stages 
of the project; there is no requirement that all patients start participating at one time. Depending on 
the patient’s state of consciousness (as determined by the Test 1 diagnosis or based on a previous 
CRS-R diagnosis prior to inclusion in the Study), they will complete a test to assess state of 

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consciousness (MCSD group) and/or a test to assess state of cognitive function (CFA group), in the 
case of a diagnosis higher than UWS. The decision to include a patient in one group or the other 
will be made by the investigator. Assuming that (for various reasons, dependent or independent of 
the patient/facility/investigator) not every patient will participate in the entire project (due to 
dropping out), the results obtained in 90 observations (45 per test) will be included in the analysis. 
This means that it is permitted to replace a patient excluded from the Study (during the course of 
the Study) with another patient. The permissible number of patients so replaced may not be greater 
than 10% of the total expected number of observations (i.e. for both groups combined: MCSD and 
CFA). The final decision to replace a patient excluded from the Study with another patient is made 
by the Primary Investigator. At the same time, it is assumed that the dropout rate allowed in the 
Study is 10% (i.e., the minimum number of patients who will participate in the entire Study is 81, 
total for both groups: MCSD and CFA). 
The number of visits per patient will depend on the test and will be (see Appendix A for a 
detailed visit): 
● 7 visits (first initial visit – screening, next five screening visits, the final  
- 
seventh one – Closing Visit) for Test 1 – Minimally Conscious State Detection Test 
(MCSD Test) 
● 5 visits (first initial visit – screening, next three screening visits, the last  
- 
fifth one – closing visit) for Test 2 – Cognitive Functions Assessment Test (CFA 
Test) 
4.1.Primary and Secondary Endpoints 
Primary endpoint: Obtaining reliable clinical data confirming the diagnosis of the state of 
consciousness and cognitive function of patients with reduced consciousness in whom the 
diagnostic tool developed during the project was applied. 
Secondary endpoint: Evaluation of differences between the results of the state of consciousness 
and cognitive functions of patients with reduced consciousness obtained by behavioural methods 
and using C-Eye X. 
The total score a patient can obtain per trial for performing tasks in the MCSD test (using the 
C-Eye X) is 11. It consists of the results obtained in the subscales of attention, language function, 
visuospatial function, autopsychic orientation, memory and abstract thinking. On the other hand, 
the total number of points a patient can obtain in a single trial for performing tasks in the CFA test 
(using the C-Eye X) is 24, and consists of scores obtained in the subscales of auditory sensitivity, 

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visual function, auditory-visual integration, command execution, autopsychic orientation and 
pressure localisation test. 
The total score that a patient can obtain in the MOCA test is 30 in a single measurement, 
consisting of the points obtained in each subscale, i.e. visual-spatial function, naming, attention, 
language, verbal fluency, abstracting, deferred recall and orientation. 
The total score a patient can obtain on the CRS-R test is 23. It consists of the scores obtained 
in each subscale, i.e. visual, auditory, motor, oromotor/verbal, communication and arousal 
functions. 
The percentages of the MCSD and CFA test scores will be compared with the relative scores 
(also reported in %) obtained by the patient in the CRS-R test and the MOCA test. This will allow 
us to capture potential discrepancies between the results of the two tests, and will also be an 
indication to change the way we diagnose patients towards using the communication channel that 
is possible in their case (vision). 
 
4.2.Study Participants 
4.2.1. Overall Description of Study Participants  
Participants will include people recovering from severe brain injury who meet the project’s 
inclusion criteria. Thus, they will be neurological patients after brain damage with communication 
barriers, diagnosed as being in unresponsive wakefulness syndrome (UWS) or minimal 
consciousness state (MCS), for whom sight is the only route of communication. 
4.2.2. Inclusion Criteria of study participants 
Criteria for patient inclusion in the Study: 
1. Completed 18 years of age. 
2. Consent of the legal guardian to participate in the Study and access to medical records. 
3. Medical diagnosis indicating damage to the central nervous system. 
4. Having and sharing a description of imaging tests (alternatively MR or CT) and 
(alternatively) ophthalmoscopy, ophthalmology, auditory tests. 
5. Presentation of a list of medications used by the patient that may affect the results obtained 
in tests of cognitive function. 

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6. Acceptance by a physician (e.g. neurologist, neurosurgeon, internist) to participate in a 
clinical trial, taken after reviewing the Study protocol, including there is a need to take into 
account: 
a. 
the ability to communicate only by sight (no verbal, sign or other communication),
b. 
the absence of dementia and aphasic disorders before the event that led to CNS 
damage and the patient’s current condition, 
c. 
preserved at least one functioning eyeball (possibility of cooperation with an eye 
tracker). 
4.2.3. Exclusion Criteria 
Criteria for excluding a patient from the Study: 
1. Visual defect (refractive defect) diagnosed before the incident, requiring work with 
glasses with lenses of more than ±3 diopters. 
2. Inclusion of drug treatment during the Study (observation), which can affect the 
patient’s cognitive functioning (both in terms of cognitive enhancement and 
impairment/dementia). 
5. 
COURSE OF STUDY  
It will take 7 months to conduct the clinical evaluation; the assumed period of 
implementation of the Study is July 2022 - January 2023. The following work will be carried 
out: 
 Recruitment of patients (acquisition of target group): 45 observations (in total from all 
the facilities included in the Study) for the diagnosis of state of consciousness – Test 
No. 1 (MCSD), and 45 observations (in total from all the facilities included in the 
Study) for the diagnosis of cognitive functions – Test No. 2 (CFA); The majority of the 
group among whom the recruitment will be carried out will include patients residing in 
facilities in Poland, about 15 –20% will be patients from facilities in Germany. 
 Conducting studies in an established group of patients at independent facilities in 
Poland and Germany. A detailed description of the activities undertaken during each 
visit and their sequence is presented in Appendix A. 
 Depending on the patient’s state of consciousness, they will participate in Stage 1 and/or 
Stage 2. The Study will consist of: 

 
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Stage 1: performing MCSD Test (5 x within 14 days). After this series of testing is 
completed, a possible test will be conducted: 
Stage 2: performing examination using the CFA Test (3 x in 14 days). 
  
The execution of MCSD will be preceded by a CRS-R test, while the execution of CFA 
will be preceded by a CRS-R and a MOCA test. 
Stage 2 can be conducted after a diagnosis above UWS is obtained in Stage 1, or bypassing 
Stage 1 if said diagnosis was obtained earlier, prior to inclusion in the Study, based on the CRS-
R test. 
6. 
SITE SELECTION: 
1. Settled situation with local NHF (applies to Polish facilities) and/or have the right 
to undertake clinical trials. 
2. The presence and secondment for the purpose of this Study of at least two persons 
– therapists (one of the specialties: physiotherapist, speech therapist, psychologist, 
educator, occupational therapist), with at least one year of experience in working 
with C- Eye, ready to work with the patient using C-Eye in the framework of the 
ongoing Study (in case one of them is unable to perform the work). The names of 
the therapists selected to work with C-Eye X in the clinical trial (investigators) must 
be known at the stage of signing the tripartite agreement (Centre - Sponsor - CRO). 
3. Investigator Certification: 
• 
the investigator has to obtain a Certificate of Training Completion for: 
‘Working with C-Eye X within the framework of a clinical trial’, 
confirming the ability to operate and work with the C-Eye X system; 
training organised by the Sponsor (after prior arrangement of the date and 
other organisational matters between the facility and AssisTech Sp. z.o.o.); 
• 
having or obtaining a GCP Certificate by the investigator. 
4. Hours of operation with C-Eye (ensuring the availability of the investigator) are 
9:00 a.m. - 6:00 p.m., conducting the Study depending on the patient’s 
activity/reactivity status. 
5. Declaration of inclusion in the Study (using C-Eye), according to the following 
guidelines: 

 
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• 
about 10 observations per Test, per facility in Poland, 
• 
about 5 observations per Test, per facility in Germany, 
whereby the determination of the details of cooperation, including financial issues, 
is carried out on the basis of the concluded tripartite agreement (Centre - Sponsor - 
CRO), defining the principles of cooperation. 
6. The rules for the therapist (investigator) to work with the patient are governed by 
the facility’s internal regulations, but if the patient feels safer in the presence of a 
family member, the family member may be present with the patient during the 
examination, under the rules set by the Contractor. 
7. 
STUDY PROCEDURES 
The launch of the Study for a patient takes place after the patient meets the inclusion 
criteria. The decision on eligibility for the Study is made by the physician after reviewing the 
screening protocol, conducted in accordance with the patient evaluation form provided by the 
Sponsor. All physicians responsible for including patients in the Study at facilities in Poland 
and Germany will qualify patients according to the same screening procedure. 
Qualified patients (or their legal guardian) must give informed consent to participate in the 
Study. Demographic and health data will be collected from project participants, which will then 
be entered by the investigator into an Electronic Case Report Form (eCRF). 
After collecting this data, the patient will perform Test 1 (MCSD). The allowable time for 
a patient to perform Test 1 five times is 15 days (the first day of testing is the day of collection 
of informed consent, medical history, physical examination and eligibility criteria – Appendix 
A), with intervals of at least one day between test repetitions. Each time, on the day the patient 
will perform Test 1, it will be preceded by a CRS-R test. The schedule of appointments for 
patients qualified for Test 1 is shown in Table 1, Appendix A. Thus, after performing the 
presented procedure five times, the patient’s state of consciousness will be described in two 
scales, which will be subject to further analysis performed under the direction of the Principal 
Investigator. 
Observation for Test 1 can be considered successful when data are collected in the patient 
within the assumed time of 15 days according to the procedure described above. A patient’s 
observation that fails to meet even one of the stated criteria (demographic and health data, CRS-
R five times, and Test 1 five times) will not be considered fully completed. 

 
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If the diagnosis of the patient’s state of consciousness obtained in Test 1 is higher than the 
UWS (so their condition will be at least MCS-) they will be qualified to perform Test 2. Patients 
who did not perform Test 1, but who had a score of at least MCS- in a previous CRS-R diagnosis 
prior to inclusion, may also be included in Test 2. 
After completing a series of 5 measurements in Test 1 (MCSD), the pucomeatient’s 
qualifying physician examines the patient at the final visit, according to the patient evaluation 
form provided by the Sponsor. 
The procedure in Test 2 (CFA), for a patient qualified by a previous CRS-R diagnosis, 
begins with the collection of data on informed consent, medical history, physical examination 
and inclusion criteria – Appendix A. These will be collected on the first day after the patient 
enters the trial and entered by the investigator into the eCRF. Patients qualifying on the basis 
of Test 1 results will be able to proceed immediately to cognitive status assessment. 
During the following 14 days, the patient will perform Test 2 three times at intervals of at 
least one day, which will be preceded each time by a MOCA and CRS-R test (Table 2, Appendix 
A). Thus, after the procedure outlined, the patient’s level of cognitive function will be described 
using two scales (behavioural: CRS-R and MOCA and electronic - C-Eye X) which, in 
combination with the results of CRS-R, will be the subject of further analysis performed under 
the direction of the Principal  Investigator. 
After completing a series of 3 measurements in Test 2 (CFA), the patient’s qualifying 
physician examines the patient at the final visit, according to the patient evaluation form 
provided by the Sponsor. 
The occurrence of any adverse reaction must be reported in accordance with the rules set 
forth later in the protocol, reported using the Adverse Event Report Form, attached as Appendix 
2 to this protocol.  
8. 
INFORMED CONSENT 
Informed consent to participate in the Study must be given by either the patient or the 
person legally responsible for the Study participant. The participant and/or the person 
responsible for the Study participant will be informed about the title of the Study, its objectives 
and goals, the ethics committee’s approval issued, the conduct of the Study, and the possibility 
of withdrawing from participation in the Study at any stage. 
Other information regarding the project and participation in the Study will be provided 
upon patient request. 

 
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Protection of personal data is ensured in accordance with Article 13 (1) and (2) of the 
General Data Protection Regulation of 27 April, 2016. (Hereinafter referred to as GDPR 
(Polish: RODO)). 
The Patient Informed Consent Form for participation in the Study is attached as Appendix 
1 to this protocol.  
9. 
SCOPE OF DATA COLLECTION  
For the purpose of broader analyses, the results obtained will be supplemented with the 
following patient demographics: 
• 
sex, 
• 
body height, 
• 
body mass, 
• 
date of birth, 
• 
education, 
• 
professional activity/occupation (before the event), 
• 
smoking, 
• 
handedness, 
• 
information about the condition of the eye (possible visual defect and its type). 
The patient health data collected will be as follows: 
• 
nature of brain damage and etiology, 
• 
date of injury occurrence, 
• 
a clinical description of the brain damage created by the imaging study, 
• 
the presence of chronic diseases before the injury, 
• 
administered medications, 
• 
having hearing and vision correcting devices before injury (including during ongoing 
examinations, all diagnostic sessions). 
10. 
RANDOMISATION AND CODEBREAKING (if applicable) 
Not applicable 
11. 
SUBSEQUENT ASSESSMENTS 
Follow-up tests are not provided for in the Study.  

 
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12. 
DEFINITION AND END OF STUDY 
Termination of the patient’s participation in the project occurs when the doctor examines the 
patient at the final visit, i.e. immediately after the last (fifth) measurement in Test 1– MCSD 
and/or the last (third) measurement in Test 2 – CFA. 
13. 
DISCONTINUATION / WITHDRAWAL OF PARTICIPANT FROM STUDY 
Each Study participant and/or Study supervisor has the right to discontinue (withdraw 
consent) at any time during the Study. 
14. 
SOURCE DATA 
The source documents used in the Study will consist of hospital records, including: 
 medical history, previous and current medications taken, 
 clinical observation sheets, 
 diagnostic Imaging. 
All documents will be kept at the medical facility implementing the Study with patients 
under conditions of confidentiality in accordance with data protection rules. In all documents 
related to the Study, in addition to the signed consent, a code – a unique patient identifier – will 
be used with respect to the Study participant, ensuring proper identification of the Study results 
collected and stored; in no case will data about the Study participant be described with their 
name. 
15. 
DESCRIPTION OF MEDICAL DEVICE 
C-Eye X is an integrated device consisting of a touchscreen computer, an eye tracker (a 
special infrared camera that tracks eye movements) and pre-installed software (run in ‘kiosk’ 
mode) that   
includes a diagnostic module in the variant under clinical evaluation in this Study (and in 
it 2 proprietary diagnostic tests: Minimal Consciousness Detection (MCSD) and Cognitive 
Function Examination (CFA). 
People with neurological dysfunctions and developmental disorders working with C-Eye 
X perform tasks based on multimedia content. The patient marks the content displayed on the 
device’s screen (i.e. graphics, photos, texts) with their eyes by focusing on it. The patient’s 

 
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choice or selection of a particular item/object displayed on the 
screen is based on holding the eye in one place for a long time.   
The user interface of the C-Eye X system was created with 
the following design considerations in mind: 
ease and intuitiveness of use of the system by the user - 
investigator, diagnostician, 
no unnecessary buttons, functionalities, hindering the 
operation of the equipment, as well as the reliability of the 
diagnosis, 
elements (different types of content, responses) with 
which, by definition, the patient interacts (through activation 
with the eyes) are maximally large, clear highly contrasting 
(in relation to the background on which they are presented), 
unambiguous so that a patient in a state of reduced 
consciousness struggling with cognitive and visual deficits 
can select them, mark them with the eyes. 
 
 
Key assumptions about the C-Eye X system: 
1. The visual fixation point (cursor) in diagnostic tests is a small grey dot with a white outline. 
The cursor was chosen so as not to attract the attention of the subject. It is not possible to 
change the cursor settings in Diagnosis. 
2. Only the answers in tasks or actions performed (such as tracking) can be marked by the 
patient’s eyes Other buttons on the screens are locked to operation by sight (e.g. commands, 
back button, etc.) – they can only be clicked by touch (this is done by the examiner, 
diagnostician).  
3. The limit for taking measurements is enabled – a maximum of one measurement per day. 
4. Marking the answers ‘by sight’ in the tasks is possible after the reading of the instruction 
by the lecturer has ended. 
5. The time to mark items ‘by sight’ is constant for most tasks at 1.2 s (e.g. time to mark 
answers in questions about name, year of birth). In tasks where actions on the screen happen 
 
Fig. 1 C-Eye X set used during the study 
 

 
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automatically (e.g. tracking, reflex inhibition, etc.), other mechanisms are used to determine 
the results. 
6. If no answer is given for 1 min, the task boards will automatically change to the next one. 
The process can be stopped by pressing pause. Screens containing instructions for the test 
taker require clicking the yellow ‘next’ arrow or entering the test result to move to the next 
board. They do not automatically change to the next. 
7. The test taker has the option to pause tasks in both tests (button 
 in the middle, at 
the bottom of the screen) – pause allows one to temporarily stop the test (during the pause 
one cannot mark the content of tasks). One can continue the test by selecting the button 
again. If one chooses to pause and exit the test, the results will not be saved. Detail 
commands/sounds are read again, after the task is restarted – if a pause was selected during 
their playback. 
8. It is not possible to cancel the selection or change the answer given. 
9. Selecting the back arrow and confirming that you want to abort the test exits the test, without 
saving the results of the completed tasks. It is not possible to return and complete an aborted 
test. 
10.  In questions about the patient’s name and year of birth, the first part of the question is read 
with a voiceover and the second part is read by a synthesiser. The voice of the synthesiser 
depends on the voices available on the device – male voices are selected first, then female 
voices (in the absence of male voices). 
Sample screens – charts from the C-Eye X diagnostic module, presented as part of the clinical 
trials conducted: 
 
 
 

 
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It is the responsibility of researchers working with C-Eye to read the investigator’s 
brochure that comes with the C-Eye X system. In addition, during the investigator training 
organised by the Sponsor, all investigators will be instructed on how to operate the C-Eye X in 
the context of conducting diagnostic tests (subject to clinical evaluation), as well as 
maintenance and safe operation of the device. 
16. SAFETY REPORTING AND DEFINITIONS 
16.1. Adverse Event (AE)  
Any medical event that causes adverse effects in a clinical trial participant, even if there is 
no causal relationship with the products used in the clinical trial. 
16.1.1. Adverse Device Effect (ADE)  
An adverse event related to the use of an investigational medical device. This includes any 
adverse events resulting from inadequacies or inaccuracies in the instructions for use, 

 
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deployment, implantation, installation, handling or malfunction of the investigational medical 
device, as well as events resulting from use error or intentional misuse. 
16.1.2. Serious Adverse Event (SAE)  
A serious adverse event that results in a subject’s death, life-threatening at the time of the 
event, the need for hospitalisation or prolongation of hospitalisation as a result of the event, 
permanent or significant impairment of health, or any other effect of the medicinal product that 
the physician, to the best of their knowledge, considers to be serious. A severe adverse event is 
also an event other than one that causes death, hospitalisation or severe life-threatening 
conditions, but which may pose an immediate threat to the Study participant or may require 
intervention to prevent one of the previously mentioned outcomes. 
Planned hospitalisation for a pre-existing condition or a procedure required by a risk 
management plan, without serious deterioration of health, is not considered a serious adverse 
event.  
16.1.3. Serious Adverse Device Effects (SADE)  
• 
Adverse operation of the device that caused any consequences in the nature of a 
severe adverse event, i.e.: 
• 
caused deaths, 
• 
led to serious deterioration of health, by: 
o life-threatening illness or injury, or 
o o permanent impairment of body structure or function, or 
o for required inpatient hospitalisation or extension of existing hospitalisation, or 
o the need for medical or surgical intervention to prevent a life-threatening illness 
or injury or permanent damage to a body structure or function. 
This includes defects in the device that may have led to a serious adverse event if: 
• 
appropriate action has not been taken, or 
• 
no intervention was made, or 
• 
had the circumstances been less fortunate. 
 

 
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16.1.4. Unanticipated Adverse Device Effect (UADE)  
Means any adverse effect on health or safety caused by or related to the device, if this effect 
or hazard was not previously recognised in terms of its nature, severity or degree of occurrence 
in the test plan, as well as any other unforeseen problem related to the device that relates to the 
rights, safety or well-being of the participants. 
An event is considered anticipated if an effect that by its nature, incidence, severity or 
outcome has been previously identified in a risk analysis report. 
16.1.5. Serious Unanticipated Adverse Device Effect (SUADE)  
A device-related serious adverse effect that, due to its nature, incidence, severity or 
consequences, is not identified in the current version of the risk analysis report.   
16.2. Reporting of AE 
The occurrence of any adverse events will be reported within 24 hours simultaneously at 
two levels: 
1) to the person representing the facility where the research is being conducted (the 
details of this person, along with their email, phone number and fax address, will 
be included in the contract with the facility) 
and 
2) to Ms Krystyna Barytska - an employee of AssisTech Sp. z o.o (email: 
krystyna.barytska@assistech.eu, mobile: +48 537 446 406 address: AssisTech Sp. 
z o.o. ul. Trzy Lipy 3, 80-172 Gdańsk, Poland). 
The form for reporting an adverse event is attached as Appendix 2 to this protocol.. 
16.3. Annual Reports 
Investigators will be required to submit Study reports to AssisTech Sp. z o.o. and the 
Principal Investigator upon completion of the Study. 
17. STATISTICS 
Statistical analysis in the project will be carried out by biostatistics specialists participating 
on behalf of an external CRO working with the Sponsor on this Study.   

 
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17.1. Description of Statistical Methods 
Nominal and ordinal scale data will be presented as counts (N) and percentages (%) in each 
of the categories analysed, with the denominator used to determine the percentages given. 
The range of summaries for interval scale variables, in each of the categories analysed, will 
include: mean with standard deviation, median and lower and upper quartile, maximum and 
minimum value, as well as the number of people for whom estimates of basic statistics were 
made. 
If graphical presentation of the data is necessary, box-plots (median, quartiles, range of 
outliers or minimum/maximum values) and/or graphs of averages with 95% confidence 
intervals will be used. 
The distribution of the variables will be evaluated based on the quantile-quantile (Q-Q) plot 
and the results of the Shapiro-Wilk test. Homogeneity of variance will be assessed using 
Levene’s test. 
For the CRS-R and MOCA tests, and the C-Eye X MCSD and CFA tests, the results will 
be presented as:  
1) the sum of scores for all subscales of the test, 
2) the point value obtained in each subscale, 
3) the percentage of the total score for all subscales of the test related to the maximum 
value possible for the test (23 points for the CRS- R test, 30 points for the MOCA 
test, 11 points for the MCSD test, 24 points for the CFA test), 
4) the percentage value in each subscale related to the maximum value possible in the 
subscale. 
In each subsequent visit following visit 1, the relative percentage increases in total and 
subscale scores will be shown for visit 1. In addition, from all consecutive visits, the sum total 
of the test and subscale scores for each test will be determined; the data will be presented as 
raw values (points) and percentages related to the sum total of the maximum possible value for 
the test/subscale. 
Analysis of the results of each test over time (in 3 or 5 consecutive visits) will be carried 
out using analysis of variance with repeated measures and contrast analysis (for raw or 
transformed data) or Friedman analysis of variance – depending on the type of data distribution, 
for both raw data and transformed percentages. 
For patients enrolled in Test 1, the percentages of total scores for all subscales of the test 
relative to the maximum value possible in the test will be used to compare the scores during the 

 
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follow-up period (in 5 consecutive visits) obtained by the MCSD C-Eye X test with those of 
the CRS-R test. The analysis will be conducted using one-way analysis of variance (the type of 
test will be a factor) with repeated measures and contrast analysis. If the assumptions of 
normality of distribution are not met, an appropriate nonparametric method or logarithmic 
transformation or aligned rank transformation will be used. The relative percentage increases 
in total scores at the last visit relative to the Visit 1 and the summed (from all measurements 
over time) total scores relative to the summed maximum possible on a given test (%) will be 
compared using Student’s t-test or Mann-Whitney U-test, depending on the type of data 
distribution. 
For patients enrolled in Test 2, the percentages of total scores for all subscales of the test 
related to the maximum value possible in the test will be used to compare the results during the 
follow-up period (in 3 consecutive visits) obtained with the CFA C-Eye X test with the results 
of the CRS-R and MOCA tests. The analysis will be conducted using one-way analysis of 
variance (the type of test will be a factor) with repeated measures and contrast analysis. If the 
assumptions of normality of distribution are not met, an appropriate nonparametric method or 
logarithmic transformation or aligned rank transformation will be used. Relative percentage 
increases in total scores at the most recent visit relative to the Visit 1 and the summed (from all 
measurements over time) total scores relative to the summed maximum possible on a given test 
(%) will be compared using one-factor analysis of variance (the type of test will be a factor) 
with Tukey’s post-hoc test or Kruskal-Wallis one-factor analysis of variance, with multiple 
comparisons tests of mean ranks for all samples, depending on the type of data distribution. 
Passing-Bablok orthogonal regression will be used to evaluate the consistency of test scores 
(summed percentages of total scores for all subscales of the test related to the maximum 
possible value for the test) of the MCSD and CFA C-Eye X with the CRS-R and MOCA tests. 
In addition, Pearson’s linear correlation coefficient or Spearman’s rank coefficient will be 
determined depending on the distribution of the data. If the assumptions of normality of 
distribution are not met, an appropriate nonparametric method or logarithmic transformation 
will be used. 
The selection of appropriate methods will be discussed further in the Statistical Analysis 
Plan. 

 
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17.2. The Number of Participants 
Due to the lack of rationale, it is not possible to statistically estimate the sample size. The 
number of participants (90 in 2 groups of 45) was chosen due to logistical feasibility and the 
Study’s budget. 
17.3. The Level of Statistical Significance 
A statistical significance level of p < 0.05 will be used. All tests will be two-sided. 
17.4. Procedure for Accounting for Missing, Unused, and Spurious Data 
Completion (imputation) of data deficiencies is not expected. For each variable analysed, 
the number and percentage of missing data in each category will be provided.  
17.5. Procedures for Reporting any Deviation(s) from the Original Statistical Plan 
Not applicable 
17.6. Inclusion in Analysis 
The results of all patients who participate in the Minimal Consciousness Detection Test 
(Test 1 – MCSD) and the Cognitive Function Examination Test (Test 2 – CFA) will be included 
in the analysis. 
18. ACCESS TO SOURCE DATA/DOCUMENTS 
Authorised representatives of the Sponsor, the facilities where the Study will be conducted, 
as well as the monitoring bodies, will have direct access to the collected data. 
19. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES 
The Study will be conducted in accordance with the currently approved study protocol, the 
approval of the Ethics Committee of the Academy of Physical Education in Wroclaw (approval 
number 11/2022) and the Helsinki Declaration, as well as the regulations and standard operating 
procedures of Poland and Germany. 
The Study will conduct regular monitoring of the procedures and manner of data collection, 
as well as its compliance with the assumptions and source documents. 
Monitors will verify this and how the study is conducted and that data is generated, 
documented and reported in accordance with applicable legal requirements. 

 
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20. ETHICS 
Prior to the Study, approval was obtained from the Senate Committee on Research Ethics 
at the Academy of Physical Education in Wroclaw (approval no. 11/2022; date: 28.03.2022). 
20.1. Approvals 
The Study has received appropriate ethics committee approvals and is conducted in 
accordance with the Declaration of Helsinki. 
20.2. Participant Confidentiality 
The Study team will ensure that the anonymity of the Subjects is maintained. Patients will 
be identified by code – the participant’s identification number on the Clinical Observation Card 
(CRF) and in the C-Eye X system. 
All documents will be securely stored and accessible only to authorised representatives of 
the Sponsor, the facilities where the study will be conducted, as well as monitoring authorities. 
The Study software environment, which is the responsibility of the external CRO, will be 
installed on a server infrastructure that provides security in accordance with ISO 27001. 
21. DATA HANDLING AND RECORD KEEPING 
The data collected will be sent electronically directly to a medical data collection platform 
that ensures information security in accordance with ISO 27001. Supervision of the security of 
the collected data will be performed by a CRO selected by the Sponsor that specialises in 
conducting such projects.  
22. FINANCING AND INSURANCE 
The research is co-financed under the National Research and Development Centre’s 
competition 2/1.1.1/2020 grant application number: POIR.01.01.01-00-2125/20. 
Insurance for patients included in the Study is provided by the Sponsor. 
23. PUBLICATION POLICY 
Publication of the results obtained in the Study will be carried out in accordance with the 
principles of good ethics in scientific research and the relevant requirements of scientific 
journals. 

 
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APPENDIX A: SCHEDULE OF PROCEDURES 
 
Test 1: Minimally Conscious State Detection Test (MCSD Test) 
Procedures 
Screening 
Visit  
1  
Visit  
2 
Visit  
3 
Visit  
4 
Visit  
5 
Final  
Visit  
 
Informed consent, Medical history, 
Physical examination, Eligibility 
criteria 
x 
  
  
  
  
  
  
 
CRS-R 
  
x 
x 
x 
x 
x 
  
 
C-Eye X 
  
x 
x 
x 
x 
x 
  
 
Completion of data in eCRF + 
uploading results from C-Eye X to 
online repository (after the visit) 
 x 
x 
x 
x 
x 
x 
 x 
 
Physical examination, Compliance 
with protocol, Adverse event 
  
  
  
  
  
  
x 
 
 
 
Test 2: Cognitive Function Assessment Test (CFA Test) 
Procedures 
Screening 
Visit  
1  
Visit  
2 
Visit  
3 
Final  
Visit 
Informed 
consent, 
Medical 
history, 
Physical 
examination, Eligibility criteria, etc. 
x 
  
  
  
 
CRS-R 
  
x 
x 
x 
  
MOCA test 
  
x 
x 
x 
  
C-Eye X 
  
x 
x 
x 
  
Completion of data in eCRF + uploading results from 
C- Eye X to online repository (after visit) 
x 
x 
x 
x 
x 
Physical examination, Compliance with protocol, 
Adverse event 
  
  
  
  
x 
 
 

 
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APPENDIX B: C-Eye X TEST RESULTS TABLES 
 
Test 1: Minimally Conscious State Detection Test (MCSD Test) 
 
Test 2: Cognitive Function Assessment Test (CFA Test) 
 

 
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Appendix 1 
INFORMED CONSENT OF THE PATIENT TO PARTICIPATE IN THE STUDY 
(ICF form) 
 
Name of the participant 
 
Name of the legal 
guardian/legal representative 
of the aforementioned 
participant: 
 
Address of residence: 
 
Phone number: 
 
 
Study title: Evaluating the use of eye-tracking technology in the diagnosis of neurological 
patients, including patients with reduced consciousness. 
Aim of the Study:  Evaluation of C-Eye X system application in the neurological diagnostics 
                   of patients with reduced consciousness. 
Demonstrating that diagnostics of the state of consciousness and cognitive function 
of patients with consciousness disorders performed using C-Eye X allows a more 
objective assessment of the condition of patients who, according to traditional 
methods, remain in no contact with the surrounding world. 
Approval was obtained from the Senate Committee on Research Ethics at the Academy of 
Physical Education in Wroclaw (approval no. 11/2022; date: 28.03.2022). 
 
I hereby declare that I have been informed in detail about the conduct of the Study and the 
participation in the Study of the participant(s), of whom I am the legal guardian/legal 
representative. I understand what the Study is about and what my consent is needed for.  
 
 
I give my informed consent to participate in the Study. 
Please turn over! 

 
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I the undersigned: 
- 
I agree to participate in the research project and am aware that I may withdraw from the 
Study at any time without giving reasons. By signing the consent to participate in the 
Study, I do not waive any due rights. I have received a copy of this form bearing my 
signature and date, 
- 
I agree that in order to monitor the correctness of the execution of the Study, 
representatives of the Sponsor of the Study  (AssisTech), the CRO of the contracted 
Study monitoring company (2KMM), as well as domestic, foreign or international 
institutions overseeing the Study, may inspect the personal data and medical records of 
the Subject (whom I represent), provided they are related to the study. 
I declare that: 
- 
I have been informed that I can ask questions about the experiment being conducted 
and the investigator will give me answers according to their best knowledge, 
- 
I am not a person deprived of liberty, I do not have an official or other relationship with 
the investigator, 
- 
I consent to the processing by AssisTech Sp. z o.o. (the Study Sponsor), based in 
Gdansk, Poland, and 2KMM (the company monitoring the Study on contract), based in 
Katowice, Poland: 
o my personal information,  
o personal data and medical data (data on health and results obtained from the 
Study) of the Subject, of whom I am the legal guardian / legal representative, 
in order to inform me of the Subject’s eligibility for the Study and to collect and process 
statistical data collected during the diagnostic observations. 
I agree to receive information with the use of means of remote communication in the form of 
telephone contact or SMS (text message) in accordance with the requirements of the General 
Data Protection Regulation (GDPR) of 27 April, 2016. 
 

 
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In addition, I declare that I have been informed that I can withdraw the consent I have given at 
any time, and that withdrawal of consent does not affect the legality of the processing carried 
out on the basis of consent before its withdrawal. I know that giving consent is voluntary but 
necessary to participate in the Study. 
  
By signing this document, I also confirm that I have read the attached Information Clause 
regarding the processing of my personal data. 
 
 
 
............................................ 
investigator's signature 
……............................................. 
signature of legal guardian/legal 
representative 
 
 
 
Location and date ………………………………………………………….. 

 
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PARTICIPANT’S STATEMENT - CONSENT TO PERSONAL DATA PROCESSING 
Name of the participant 
 
Name of the legal 
guardian/legal representative 
of the aforementioned 
participant: 
 
Address of residence: 
 
Phone number: 
 
 
Subject of the Study: Evaluating the use of eye-tracking technology in the diagnosis of 
neurological patients, including patients with reduced consciousness. 
 
In accordance with Article 13(1) and (2) of the General Data Protection Regulation of 
27 April, 2016 (hereinafter referred to as GDPR/Polish: RODO), I would like to inform you 
that: 
 
1. Your personal data controller is AssisTech Sp. z o.o., based in Gdansk, St. Trzy Lipy 3 
2. The contact person for data protection issues at AssisTech Sp. z o.o. is the Data 
Protection Officer: Izabela Maksim: izabela.maksim@assistech.eu, mobile 537 446 406 
3. Your personal data will be processed for: 
- 
implementing a new diagnostic method to improve the neurological diagnosis of 
patients with decreased consciousness using an eye tracking technique, 
- 
protecting the health of patients by informing them of the opportunity to participate in 
a clinical trial (resulting from research work), 
- 
assessing eligibility for the Study and invitation to participate in the Study, 
- 
reporting on the effects of the Study, 
using remote communication in the form of telephone contact or SMS (text message), 
based on Article 6(1)(a) of the General Data Protection Regulation of 27 April, 2016. 

 
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4. The recipients of your personal data will be authorised employees of the data controller and 
entities that – within the framework of contracts binding them with the controller – carry 
out the purpose of processing expressed in item 3. 
5. Your personal data will not be transferred to third countries and international organisations. 
6. Your personal data will be kept for the period necessary due to the business needs of the 
data controller, but no longer than 20 years. 
7. You have the right to access the content of your data and the right to rectify, erase, restrict 
processing, the right to data portability, the right to object, the right to withdraw consent 
at any time without affecting the legality of the processing carried out on the basis of 
consent before its withdrawal. 
8. You have the right to lodge a complaint with a supervisory authority if you consider that 
the processing of personal data concerning you violates the provisions of the 
GDPR/RODO. 
9. Your provision of personal data is voluntary, and the consequence of failure to provide 
personal data will be the inability to fulfil the purposes indicated in item 3. 
10. Your personal data will not be processed through profiling. 
 
I hereby declare that I consent to the processing of personal data of the participant and 
myself to the extent necessary for the implementation of the research project in which I 
participate. 
 
 
 
............................................ 
investigator's signature 
……............................................. 
signature of legal guardian/legal 
representative 
 
 
 
location and date ………………………………………………………….. 

 
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Appendix 2 
ADVERSE EVENT REPORT FORM 
 
Fill out the form and email it to krystyna.barytska@assistech.eu  or call +48 537 446 406 
 
Patient information 
Patient ID: 
 
Date of birth (DD-MM-YYYY): 
____ - ____ - ________ 
Body height (cm): 
Body mass (kg): 
Sex: 
□ M   □ F 
 
Information about the adverse event 
Report type:    Primary report      Follow-up report 
Date of obtaining information about the event (DD-MM-YYYY)  
____ - ____ - ________ 
Date the event occurred (DD-MM-YYYY):____ - 
____ - ________ 
Date the event ceased (DD-MM-YYYY): 
____ - ____ - ________ 
 The event is still ongoing 
Description of adverse event: 
 
 
 
 
 
 
Event classification 
☐ Severe adverse event 
☐ Death, date (DD-MM-YYYY): ____ - ____ - ________  
☐ Threat to life 
☐ Permanent or significant disability or impairment 
☐ Hospitalisation/extension of it date from: ____ - ____ - ________ □ continues 
☐ Other medically relevant 
☐ Non-serious adverse event 
 
 

 
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Linking an adverse event to C-Eye X: 
□ definitely related 
□ high probability of relation 
□ likely related 
□ doubtful relation 
□ unrelated 
Justification for linking the event to C-Eye X: 
Event outcome: 
□ recovery                                                   □ recovery with permanent consequences 
□ under treatment                                        □ no successful treatment 
□ fatal                                                          □ unknown 
Additional information (laboratory tests, medical history, etc.): 
 
 
 
 
 
 
 
 
 
 
Information on the reporting person 
First name: 
Surname: 
Email address: 
Phone numer: 
Signature: 
Date of the report (DD-MM-YYYY): 
____ - ____ - ________