Etude de l'ANesthésie Par Gel de Lidocaïne Pour Les Injections IntrA vitréennes
Conditions: Retinal Diseases - AMD - PAIN - Intravitreal Injection
Sponsor: Institut Ophtalmologique de l'Ouest Jules Verne

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2022-A00702-41_Summary_V5_2022_06_03_ANGLIA
 
SELARL OPHTALLIANCE 
 
 
 
 
 
 
 
RESEARCH SUMMARY 
 
 
 
 
 
Reserved for the 
promoter
 
ID RCB No 
CPP No 
CNIL or MR No  
 
2022-A00702- 
41 
 
22.01643.000097
MR003 
Ref 2219976 v 0
 
 
 
Regulatory 
qualification 
 RIPH of the 1st drug 
 RIPH of the 1st innovative 
therapy drug 
 RIPH of a medical device 
 RIPH of 1° excluding health products 
 2° RIPH with minimal 
risks and constraints 
3° RIPH nointerventional 
 
Summary of the research protocol for RIPH 3 comprising only qestionnaires and 
interviews decree of December 21, 2018 
 
 
 
 
Short title: ANGLIA 
VERSION N°5 03/06/2022 
 
 
Monocentric 
National 
 
 Multicentric 
European/International 
 
 
Promoter: 
SELARL Ophtalliance 
Network of 46 ophthalmic physicians 
and surgeons practicing 
in 11 centers in the west of France 
 
 
Address: 88 Rue de Hauts Pavés 
44000 Nantes 
Contact: Anne BARRUCAND 
Methodologist- biostatistician 
Institut ophtalmologique de 
(IOO) Jules Verne  
Clinical Research Department 
PI: Dr. Jean-François LE ROUIC 
Email: anne.barrucand@ophtalliance.fr 
Phone: +33 6 72 08 34 15 
FULL TITLE: Study of lidocaine gel anesthesia for intravitreal 
injections 

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2022-A00702-41_Summary_V5_2022_06_03_ANGLIA
 
SELARL OPHTALLIANCE 
 
 
 
 
 
 
 
 
Compliance of this request for an opinion with the procedure provided for in II 
of Article R.1123-20 of the Public Health Code: 
 This research only includes data collected by questionnaire(s) or interview(s): 
Yes 
 
No 
 
 
 This research has no consequences for the participants either in terms of safety or 
modification of the usual care: 
Yes 
 
No 
 
 
 
 This research is risk-free and the disadvantages for the people participating in 
the research are negligible: 
Yes 
 
No 
 
 
 
 The collection and processing of data implemented in this research complies with the 
reference methodology MR003 approved by the CNIL: 
Yes 
 
No 
 
 
HISTORY OF PROTOCOL UPDATES 
 
VERSION 
DATE 
REASON FOR UPDATE 
 
4 
 
06/03/2022 
 
ASKED OF MODIFICATION OR OF INFORMATION 
FROM THE CPP 
 
 
 

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2022-A00702-41_Summary_V5_2022_06_03_ANGLIA
SELARL OPHTALLIANCE
RESEARCH SUMMARY.................................................................................................................................1
I
INFORMATIONADMINISTRATIVE ............................................................................................................5
RESEARCH.................................................................................................................................................5
PROMOTER ........................................................................................................................................ 5
PRINCIPAL INVESTIGATOR ......................................................................................................................5
II
CONTEXT AND JUSTIFICATION OF THE RESEARCH: RATIONAL PRESENTING THE CONTEXT
AND THE ASSUMPTIONS OF RESEARCH...................................................................................................6
III
OBJECTIVES AND JUDGEMENT CRITERIA..........................................................................................8
IV. - STUDY ORGANIZATION.........................................................................................................................9
A.
SYNTHETIC DESCRIPTION OF THE STUDY SCHEME ....................................................................9
B.
QUESTIONNAIRE METHODOLOGY /INTERVIEWS.........................................................................13
V. - INFORMATION RELATING TO THE IMPLEMENTATION OF THE RESEARCH..................................16
PROCESSING RELATING TO THE DATA OF PERSONS CONCERNED BY RESEARCH .......................22
ORIGIN OF PERSONAL DATA.................................................................................................................22
ARE SENSITIVE DATA PROCESSED?....................................................................................................22
DATA CATEGORIES COLLECTED ..........................................................................................................22
DATA RECIPIENTS CATEGORIES ..........................................................................................................24
   SECURITY MEASURES ...........................................................................................................................25
DATA CONFIDENTIALITY ........................................................................................................................25
DATA ENTRY AND PROCESSING...........................................................................................................26
DATA SAFETY ..........................................................................................................................................27
IT SECURITY ............................................................................................................................................28
DATA SECURITY PAPER.........................................................................................................................28
DATA CATEGORIES STORAGE TIME.....................................................................................................28
AUDIT AND INSPECTION ............................................................................................................................29
CERTIFICATE ....................................................................................................................................... 30
BIBLIOGRAPHY ................................................................................................................................ 31
TABLESUBJECTS

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RESEARCH TITLE
Study of lidocaine gel anesthesia for 
intravitreal injections
SHORT TITLE OF RESEARCH
ANGLIA
REGISTRATION NUMBER (ID-RCB)
2022-A00702-41
NAME OR LEGAL FORM AND NAME
Ophtalliance 
SELARL
COMPLETE ADDRESS
88 Rue de Hauts Pavés - 44000 Nantes
PHONE
+33 2 51 77 75 27
NAME, FIRST NAME
Dr LE ROUIC Jean-François
FUNCTION
Qualification: ophthalmologist 
Specialties:
-
Vitreoretinal surgery
-
AMD (Age-Related Macular Degeneration)
-
Medical pathologies of the retina
-
Cataract surgery
-
IVT (Intravitreal injections)
RESEARCH
I ADMINISTRATIVE INFORMATION
PROMOTER
PRINCIPAL INVESTIGATOR

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RESEARCH LOCATION
2-4 Route de Paris 
44300 Nantes
PHONE
+33 2 28 44 33 73
EMAIL
jflerouic@gmail.com
Intravitreal injections (IVT) of anti-vascular endothelial growth factor (VEGF) and 
corticosteroids are the standard treatment to combat various retinal pathologies such as neo-
vascular age-related macular degeneration (AMD), macular edema occurring during retinal 
vein occlusions, diabetic macular 
An injection of these anti-factors stops the proliferation of abnormal vessels and reduces 
macular edema [2].
These injections are very effective but must be renewed regularly (on average every 2 months), 
for several years. Despite the anesthesia (usually topical) administered before each injection, 
some patients complain of feeling discomfort or even pain when placing the blepharostat (the 
device that keeps the eyelids apart) and inserting the needle through the sclera.[3]
Although the percentage of patients perceiving severe pain during an IVT session is low [4], 
pain management for these patients represents an important issue not only for their comfort 
but also for treatment compliance. It is important to reduce it effectively to improve patient 
management. The patient requires pain management when the score is greater than 3-4/10 
on the VAS (Visual Analogue Scale which is the reference scale)[5].
II CONTEXT AND JUSTIFICATION OF THE RESEARCH: RATIONALE PRESENTING THE CONTEXT AND THE 
RESEARCH HYPOTHESES

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Topical anesthesia using anesthetic drops (Tetracaine® or Oxybuprocaine®) is the reference 
method.
It is also possible to offer patients topical anesthesia by the instillation of eye drops 
(Tetracaïne® or Oxybuprocaïne®) associated with so-called "improved" topical anesthesia
» by the preoperative instillation of a drop of lidocaine gel: Ophtesic®. This protocol has 
obtained the favorable opinion of the ANSM but is currently little used. [6]. Several studies have 
proven the safety and efficacy of lidocaine gel for anesthesia during eye surgery [6 9]
In our practice at the IOO, we use the reference method as first intention, and we offer lidocaine 
gel to people complaining of having had pain during previous IVT sessions.
This practice carried out at the IOO has never been evaluated. In addition, there are several 
studies dealing with pain at the time of injection [10 17] and comparing different anesthetics 
[18 20], however they were carried out on a non-targeted population.
-
dose container, does not provide any improvement in actual benefit (ASMR V) compared with 
anesthetic eye drops in the topical anesthesia during ophthalmic procedures. ". However, in 
our practice, patients who received topical anesthesia for IVT using anesthetic drops 
(Tetracaine® or Oxybuprocaine®), associated with a drop of lidocaine gel, report less pain, 
especially when placing the blepharostat.
The aim of this study, which includes two parts, is to better understand the prevalence of pain 
and its intensity during IVT and then to evaluate the effectiveness of the protocol using a drop 
of lidocaine gel on a targeted population (patien
the management of patients complaining of severe pain during the injection.
We will first assess the perception of pain and its intensity during IVT using questionnaire 1. 
Once this step has been completed, we will suggest that the patients who have felt the most 
assess the pain felt with questionnaire 2.

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The study will therefore consist of analyzing the responses to a survey carried out using 2 
questionnaires offered during 2 IVT sessions for the same patient:
-
Quiz 1: survey carried out in the context of anesthesia with the reference method
-
Quiz 2: survey carried out during improved anesthesia (protocol to be evaluated): 
Tetracaine® or Oxybuprocaine® eye drops combined with a drop of lidocaine gel.
Pain being strongly correlated with the psychological state of the patient, and his degree of 
anxiety before the injection [13] , a psychological evaluation of the patient before the 
intervention will be carried out using the HAD Anxiety Scale (Hospital Anxiety and Depression 
Scale) by AS Zigmond and RP Snaith (French Translation JL Lépine) during the 2 
questionnaires.
MAIN OBJECTIVE
The main objective of this study is to evaluate the relief provided by 
so-called "improved" topical anesthesia by the preoperative 
instillation of a drop of lidocaine gel in addition to a drop of the 
anesthetic Tetracaine® or Oxybuprocaine® in patients perceiving 
severe pain during IVT compared to the reference anesthesia 
protocol.
MAIN JUDGMENT
CRITERIA
EVA Score: The figure will be rounded to the nearest millimeter
Comparison of the pain score felt during the injection during the 1st 
evaluation (with conventional anesthesia) with the pain score 
obtained during improved anesthesia.
SECONDARY OBJECTIVES
1- Confirmation of pain relief with the score obtained on the 
simple verbal scale
2- Description of the prevalence and intensity of pain 
experienced by patients during IVT
3- Description of the psychological state of the patient during a
IVT and validation of score stability
III OBJECTIVES AND JUDGMENT CRITERIA

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4- Evaluation of the security of the protocol
SECONDARY JUDGMENT
CRITERIA
1.
Descriptive statistics of the verbal scale score
2.
Descriptive statistics of pain scores recorded during pain 
assessment using VAS for IVT with conventional topical 
anesthesia
3.
Descriptive statistics of the psychological state of the 
study population. Comparison of the scores obtained 
between the 2 assessments
4.
Description of possible side effects
SYNTHETIC 
DESCRIPTION
Monocentric study
1.
Initial evaluation of the pain felt by patients during an 
intravitreal injection (IVT) as well as their psychological state 
before the intervention
The basis for this evaluation is a questionnaire completed by the 
participants before and after the injection.
It is composed :
-
A psychological assessment (the HAD Anxiety Scale (Hospital 
Anxiety and Depression Scale - Authors: AS Zigmond and RP 
Snaith - French translation JL Lépine) completed by the patient 
before the IVT
-
2 measures for pain assessment using VAS:
o
One to assess the pain felt when placing the 
blepharostat
o
The other to assess the pain felt when inserting the 
needle: answer given just after the IVT session.
A. - SYNTHETIC DESCRIPTION OF THE STUDY SCHEME
IV. - ORGANIZATION OF THE STUDY:

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2.
Selection of patients who felt the most pain (EVA
Tetracaine® or Oxybuprocaine® and a drop of lidocaine gel.
Evaluation of pain and relief of patients during IVT with so-
called "enhanced" topical anesthesia.
The basis for this evaluation also consists of a questionnaire completed 
by the participants before and after the injection.
It is composed :
-
A psychological assessment (HAD Anxiety Scale (Hospital 
Anxiety and Depression Scale - Authors: AS Zigmond and RP 
Snaith) completed by the patient before IVT
-
Of 2 measures for the evaluation of pain using VAS: one to 
evaluate the pain felt when inserting the blepharostat and the 
other to evaluate the pain felt when inserting the needle: 
response performed immediately after the IVT session.
-
An assessment of pain relief: Simple verbal scale (1 for placing 
the blepharostat and the other for inserting the needle)
The answers to the questionnaires will be collected by one of the nurses 
(TEC or ARC) and the ARC orthoptists and the anonymized data will 
be sent to the biostatistician of the clinical research department for 
analysis.
DESCRIPTION OF 
THE PROCEDURE OF 
THE IVT
The injection is performed in the operating room dedicated to IVT at 
the Jules Verne clinic
Anesthesia procedure: reference method:
-Instillation of a drop of topical anesthetic: Tetracaine® or
Oxybuprocaine®

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-
Initial cleansing of the surface of the patient's periocular skin 
with povidone iodine scrub. Rinse with saline solution and dry 
with sterile compresses.
-
Instillation on the conjunctiva of a drop of povidone iodine in a 
5% ophthalmic solution. After 2 minutes.
-
Instillation of 2 drops 
of 
anesthetic: Tetracaine® 
or 
Oxybuprocaine®
Anesthesia procedure: with lidocaine gel:
-
Instillation of a drop of topical anesthetic: Tetracaine® or 
Oxybuprocaine®
-
Initial cleansing of the surface of the patient's periocular skin 
with povidone iodine scrub. Rinse with saline solution and dry 
with sterile compresses.
-
Instillation on the conjunctiva of a drop of povidone iodine in a 
5% ophthalmic solution.
-
Instillation of lidocaine gel drop
Procedure common to both anesthesia protocols
-
Preparation of the syringe containing the product to be injected 
in a sterile manner by the operator as close as possible to the 
injection
-
Placement of a sterile drape isolating the patient's eye
-
Placement of a blepharostat so as to limit the risk of contact 
between the needle and the free edge of the eyelids or 
eyelashes.
-
IVT between 3.5 and 4 mm from the limbus: slow injection of 
the product
-
Slow needle withdrawal.

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COURSE OF THE 
STUDY
The research includes 2 parts:
-
Evaluation of the prevalence of pain and its intensity 
during an IVT.
Cohort: For 15 days: distribution of the information letter during the 
consultation to all patients requiring IVT
-
Evaluation of the effectiveness of the protocol using a 
drop of lidocaine gel
Cohort: patients experiencing pain requiring management (VAS score 

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Recruitment of patients will be done on the voluntary participation of 
patients.
The information letter will be submitted for consultation and the 
evaluation will be scheduled during the next IVT session so that the 
person has time to reflect before making their decision.
Participants may withdraw their consent at any time.
Proposal to all patients with IVT between .. /.. / .... and .. /.. /....
To complete a questionnaire in order to assess:
- The intensity of pain felt during an intravitreal injection (IVT)
- The psychological state before the intervention
Patient accepts to answer the 
questionnaire--> included
VAS pain score < 4
VAS pain score > 4
End of the study
Proposal to test
anesthesia with 
lidocaine gel: Ophtesic
End of the study
questionnaire 2
Patient refuses
Patient refuses 
to answer the 
questionnaire
Patient 
accepts
Not included

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AWARDING 
PROCEDURE
Questionnaires administered by:
Mail
Internet
Phone
Face to face: during the IVT
Questionnaire administered in:
Once
Several times (specify the number of awards): 2
Questionnaire type:
Validated
Invalid
if validated, indicate the origin of the validation:
For assessment of psychological state and anxiety before the 
intervention: HAD Anxiety Scale (Hospital Anxiety and Depression 
Scale - Authors: AS Zigmond and RP Snaith - French translation 
JL Lépine)
For pain assessment: Analogue Visual Scale (EVA): ranging 
from 1 to 10 cm
For assessment of pain relief: Simple verbal scale.
if not validated, justify:
Does the research also involve collecting retrospective data:
B- METHODOLOGY OF QUESTIONNAIRES / INTERVIEWS

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yes
No
if yes, justify:
The number of previous IVTs, the pathology requiring the IVT, eye 
treatments, allergies, history of eye surgery, use of oral analgesics 
will be collected by the nurses from the patients' medical files.
INTERVIEW
Methods of realization :
Individual interview
Collective interview
Interview carried out in:
Frontface to face during the IVT session
video conference
phone
Other (explain, list) :
Interview carried out:
once
several times 
Number of awards: 2
Type of maintenance:
directive
semi-directive
non directive
Registration:
No
yes

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STATISTICAL DATA 
ANALYSIS
Pseudo-anonymized data will be collected on an Epi-data 
spreadsheet
The analysis will be carried out using the statistical analysis 
software: R version 3.4.4 (R-project)
Descriptive statistical analysis
The results will be presented:
-
As mean +- sd (min; max) for quantitative 
variables
-
As a percentage for qualitative variables
Main criterion:
Comparison of the score obtained during the 1st evaluation (with 
conventional anesthesia) with the score obtained during improved 
anesthesia: paired T-test
Other analyses:
Data that were found statistically correlated to the result:
-
The psychological state of the patient[13.22]
Comparison of the scores obtained between the 2 evaluations of 
the psychological state (HAD scale): paired t-test
-
The injection site [23]
-
The number of prior IVTs[23]
-
gender and age[24]
Comparison of pain scores according to potentially correlated 
factors: multivariate analysis
REFERENCES OF 
THE 
RESPONSIBLE 
BIOSTATISTICIAN
Last name First Name : BARRUCAND Anne
Address: Jules Verne West Ophthalmological Institute 
Clinical Research Department
2-4 route de Paris - 44300 NANTES

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Telephone: 06 72 08 34 15
Email:anne.barrucand@ophtalliance.fr
PLACES OF RESEARCH
Ophtalliance Ophthalmology Center:
- Ophthalmological Institute of the West Jules Verne Clinic
2/4 Route de Paris 
44300 NANTES
PROVISIONAL 
RESEARCH 
TIMETABLE
Start of study: Upon receipt of the opinion of the CPP
Duration of the inclusion period: 15 days (for phase 1 and for 
phase 2: these are the patients selected from the phase 1 cohort)
End of study report: August 2022
NUMBER OF 
INTERVIEWEES
1st part: All patients who are called for an IVT over a period of 15 
days and who have given their consent to participate in clinical 
research: approximately 300 patients
2nd part: patients who felt sever
who consent to test another protocol (estimate: 40 to 60 patients)
INCLUSION CRITERIA
1st QUESTIONNAIRE
-
Over 18
-
Participants having all their capacities of discernment and 
being able to answer the questionnaires
-
Patient summoned for an intravitreal injection of an anti-
VEGF drug in liquid form (ranibizumab, aflibercept, 
bevacizumab)
-
Indication for injection: painless retinal pathology (age-
related macular degeneration, retinopathy
diabetic, macular edema on venous occlusion
V. - INFORMATION RELATING TO THE IMPLEMENTATION OF THE RESEARCH:

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retinal, neovascular membrane on high myopia, or other).
-Note
information given to the patient and collection of 
signed non-objection
EXCLUSION CRITERIA 
1st QUESTIONNAIRE
-
Persons cited in articles L.1121-6 to L.1121-8 of the CSP
-
Patients not followed at the IOO Jules Verne or at the 
Hauts Pavés practice.
-
Eye pain before the procedure
-
Intravitreal injections performed with
oftriamcinolone acetonide
-
Intravitreal injections performed with a larger gauge needle 
(Ozurdex® or Iluvien ®)
-
Intravitreal injections performed using a disinfectant other 
than povidone iodine
-
Patients for whom the protocol with lidocaine gel in 
anesthesia is already used
-
Any cortisone injection
-
Any uveitic inflammatory pathology whether immunological 
or infectious
-
Anyone under systemic treatment with cortisone or 
morphine and its derivatives
INCLUSION CRITERIA
2nd QUESTIONNAIRE
-
4/10
-
Patients who have given their consent to switch to the 
protocol with the addition of lidocaine gel (information letter 
provided and collection of non-objection)
EXCLUSION CRITERIA 
2nd QUESTIONNAIRE
-
Eye pain before the procedure
-
patient takingadditional or different analgesic treatment 
compared to the evaluation of the 1st questionnaire
-
Known allergy to lidocaine or any of the other ingredients of 
Ophtesic (hypromellose (E464) type 2910, sodium 
hydroxide (E524), hydrochloric acid (E507))
-
Presence before IVT of the following symptoms: ocular 
redness, burning sensation, corneal pathology, headache.
DOES THE RESEARCH 
INCLUDE PEOPLE WITH 
NO CONDITION?
No
yes

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All people included are people who have an appointment for an 
Intra Vitreous Injection (IVT)
PERSONAL 
RECRUITMENT 
PROCEDURES
All patients who made an appointment for an Intra Vitreous 
Injection (IVT) at the IOO Jules Verne during the recruitment 
period.
INFORMATION AND 
TRACEABILITY 
PROCEDURES FOR NON-
OPPOSITION
Patient information
Patients will be fully and fairly informed, in understandable terms, 
of the objectives of the study, the nature of the information 
collected, and their right to object at any time to the use of the data 
collected.
All this information appears on an information form given to patients 
during their preoperative consultation.
Patients will be informed of the following:
-
Presentation of the research project
-
The nature of the information that will be used for this 
research
-
The recipient of the data
In accordance to European Regulation No. 2016/679/EU of April 
27, 2016 (applicable from May 25, 2018) and the amended 
Computers and Liberty
benefits from the following rights:
-
Right of access, rectification, portability and erasure of 
their data
-
Right to limit the processing of their data
For legitimate reasons, the right to oppose the processing of data 
concerning them
Collection not opposed
Patients will have to stipulate if they agree that we use their 
answers to the questionnaires

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DISADVANTAGES FOR 
PEOPLE INCLUDED IN 
THE RESEARCH
The answers to a questionnaire during an IVT do not present a 
risk for the patient.
Evaluation of our current practice using a questionnaire
DESCRIPTION OF THE 
DIFFERENT ANESTHETIC 
EYE DROPS USED 
DURING IVT
TETRACAINE 1 PER CENT THEA, eye drops in solution in
single-dose container Tetracaine Hydrochloride[25]
Eye drops in solution, contains an active substance, Tetracaine®. 
This substance is a local anesthetic capable of penetrating certain 
parts of the eye such as the cornea and the conjunctiva.
This drug is indicated as a local anesthetic during various surgical 
procedures or various eye examinations.
The side effects listed below are from post-marketing experience 
with tetracaine. Since these effects were reported spontaneously 
by a population of indeterminate size, it is not possible to estimate 
their frequency precisely, which is therefore considered to be 
indeterminate.
-
Immune system disorders
Hypersensitivity including erythema, pruritus.
-
Eye conditions
Keratitis (including ulcerative keratitis), corneal erosion, corneal 
oedema, eye irritation, eye pain.
.
OXYBUPROCAINE THEA HYDROCHLORIDE 1.6mg/0.4ml,
eye drops in a single-dose container Oxybuprocaine 
Hydrochloride
[26]
Ophthalmic local anesthetic

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Like all medicines, this medicine can cause side effects, although 
not everyone gets them.
-
A few collapses with bradycardia have been exceptionally 
reported
-
Possibility of transient tingling or irritation upon instillation.
OPHTESIC 20 mg/g, ophthalmic gel in single-dose container
lidocaine hydrochloride[27]
OPHTESIC is an anesthetic ophthalmic gel used during ophthalmic 
procedures.
According to the public drug database, the following side effects of 
lidocaine gel have been described with an unknown frequency:
-
Conjunctival redness, changes in corneal epithelium, eye 
burning sensation, pitted corneal inflammation, corneal 
swelling
EXPECTED DURATION OF 
DATA COLLECTION BY 
INTERVIEW OR 
QUESTIONNAIRE FOR A 
PARTICIPANT
The duration of the interview is estimated at: 5-10 minutes for each 
questionnaire.
TOTAL FORECAST 
DURATION OF RESEARCH 
PARTICIPATION FOR A 
PARTICIPANT IF DATA 
COLLECTION IS CARRIED 
OUT SEVERAL TIMES
-
5-10 minutes for the 1st assessment
-
5-10 minutes for the 2nd assessment

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MAXIMUM ESTIMATED 
TRANSPORT TIME FOR 
PARTICIPANTS
no transportation
1st questionnaire: the day of the 
IVT 2nd questionnaire: the day of 
the IVT
MAXIMUM ESTIMATED 
TRANSPORT TIME FOR 
PARTICIPANTS
no transportation
1st questionnaire: the day of the consultation, IVT or surgery
2nd questionnaire carried out: if the patient had a VAS score 
greater than or equal to 4 and switched to the so-called improved 
anesthesia protocol with lidocaine gel
NAME AND CONTACT 
DETAILS OF THE DATA 
PROTECTION OFFICER
Last name First Name : BOSC François 
Address: Jules Verne West Ophthalmological Institute 
Clinical Research Department
2-4 route de Paris - 44300 NANTES
Email: f.bosc@ophtalliance.fr

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Pursuant to Article 5, paragraph 1, point c of the GDPR, the data processed must be adequate, 
relevant, and limited to what is strictly necessary in relation to the purposes of the processing. 
In this respect, the data controller undertakes to collect only the data strictly necessary and 
relevant to the objectives of the research..
The data relating to the persons lending themselves to research will come exclusively from the 
interested parties themselves.
The collection of certain data, particularly sensitive, is strictly regulated by the GDPR and 
requires special vigilance. These are data revealing the alleged racial or ethnic origin, 
political opinions, religious or philosophical beliefs or trade union membership of 
individuals, genetic and biometric data, data concerning health, sex life or sexual 
orientation of persons, data relating to criminal convictions or offenses, as well as the 
unique national identification number (NIR or social security number).
YES
NO
If so why ? :
The data demographic
-
Pseudo-anonymized data: one number per patient
RESEARCHES

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Exclusion: surname, first name, registration number in the national identification directory
natural persons)
-
Age (Only the year of birth will be collected to get the age)
-
Sex
Clinical data
1Number of prior IVTs (< 3 | | ; 4 to 10 | | ; > 11 | |)
2Injected product
3Pathology requiring the injection
4Needle gauge for IVT
5Dial in which the IVT is carried out
6Anesthetic
7Eye treatments
8allergies
9History of eye surgeries
10Oral pain medication: 
YES
NO
The answers to the questionnaires
-
The answers to questionnaire 1:
HAD Anxiety Scale (Hospital Anxiety and Depression Scale - Authors: AS 
Zigmond and RP Snaith - French translation JL Lépine)
Measurement of pain intensity at the time of placement of theblepharostat: 
EVA scale (1 to 10)
Measurement of pain intensity at the time of injection: EVA scale (1 to10)
-
The answers to questionnaire number 2(for patients who experienced 
asignificant pain (EVA > 4)

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HAD Anxiety Scale (Hospital Anxiety and Depression Scale - Authors: AS 
Zigmond and RP Snaith - French translation JL Lépine)
Measurement of pain intensityat the time of placement of the blepharostat: 
EVA scale (1 to 10)
Measurement of pain intensityat the time of injection: EVA scale (1 to 10)
Measure of pain relief: simple verbal scale (0 to 4)
DATA RECIPIENTS CATEGORIES
Internal recipients
Jean-François Le Rouic: Ophthalmologist
Principal investigator
Charlotte Clemenceau: Nurse
Responsible for :
-
Administration of questionnaires
Sophie Dupouy: TEC nurse
Responsible for :
-
Perform data entry (epidata software)
Sandra Delaunay: ARC Orthoptist
Responsible for :
-
Responsible for controlling data entry
Héloïse De Neuville: CRA nurse
Responsible for :
-
Administration of questionnaires
Marie-Lou Charles: ARC Orthoptist
Responsible for :
-
Make the entrydata (epidata software)
Anne Barrucand: biostatistician
Responsible for :
-
Perform statistical analysis
External recipients (e.g. funder, subsidiaries, partners, etc.)
Study carried out internally

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Transfers of data outside the EU: is personal data transferred outside the European Union?
YES
NO
If so, to which country (ies)? :
In specific situations (transfer to a third country not covered by an adequacy decision of the 
European Commission, and without the guarantees mentioned in Articles 46 and 47 of the 
GDPR), specific guarantees must be provided for and documented in theregister (Article 49 
of the GDPR). Consult the CNIL website
No external data transfer will not be carried out, research is conducted internally. Its purpose 
is to answer the questions of Ophtalliance doctors who wish to evaluate their current practice.
SECURITY MEASURES
The data will be protected according to the General Data Protection Regulation GDPR.
Access to the data will be under the responsibility of the data controller: Dr JF Le Rouic
DATA CONFIDENTIALITY
In accordance with the legislative provisions in force (ArticlesL.1121-3 and R.5121-13 of the 
Public Health Code), persons having direct access to source data will take all necessary 
precautions to ensure the confidentiality of information relating to persons who agree to it. and 
in particular with regard to their identity as well as to results obtained. These people, like the 
doctors themselves, are subject to professional secrecy.
During the research or at its end, the data collected on the people who agree to it and 
transmitted to the promoter by the doctors (or any other specialized contributors) will be made 
pseudo-anonymous. Under no circumstances will they clearly show the names of the persons 
concerned or their addresses:
-
Number to identify patients

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-
Only the year of birth is collected
-
no address
-
No phone number
-
No social security number
DATA ENTRY AND PROCESSING
Data entry into a spreadsheet will be done by
-
The CRA: Marie-Lou Charles
-
The TEC nurse: Sophie Dupouy
They will be responsible for data entry from the answers to the questionnaires on a 
spreadsheet.
The data will be protected according to the General Data Protection Regulation (GDPR). The 
patient's references will therefore be pseudo-anonymized: only a patient number will appear in 
the spreadsheet
Sandra Delaunay, ARC orthoptist will be responsible for monitoring and verifying:
-
The collection of non-objection from patients
-
Compliance with inclusion and exclusion criteria
-
Compliance with Good Clinical Practices
-
The quality and integrity of the data collected, any missing data
Then she will send the spreadsheet in csv format (spreadsheet with only the patient numbers) 
to Anne Barrucand, the biostatistician in charge of the statistical analysis.
Anne Barrucand will not have access to the patient name/number correspondence table nor to
the data source.
The data management of the study database will be carried out using the R version software
3.4.4 (R-project) by the biostatistician Anne Barrucand in order to verify the consistency of the 
information. If the check highlights certain errors, Sandra Delaunay will be in charge of verifying 
the information in the source data.

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Once the verification process is complete, the freezing of the database will be decided in a 
concerted manner between the promoter (SELARL Ophtalliance), the investigator (Dr. JF Le
Rouic) and the biostatistician (A. Barrucand)
DATA SECURITY
The data will be protected according to the General Data Protection Regulation GDPR.
Access to the data will be under the responsibility of the data controller: Dr JF Le Rouic
He will be the only one to keep the table of correspondence between the coded identity of the 
participant in the search and its name.
The data controller as well as the persons as well as the following persons:
Jean-François Le Rouic: Ophthalmologist
Sophie Dupouy: TEC nurse
Sandra Delaunay: ARC Orthoptist
Héloïse De Neuville: CRA nurse
Marie Lou Charles: ARC Orthoptist
Charlotte Clemenceau : Nurse
are the only persons authorized to access the data of patients who did not opposed to 
participating in the research.
The people mentioned above are certified: Good Clinical Practice ICH E6.

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IT SECURITY
The spreadsheet and computer data will be stored on a clinic server that has an ISO 27000 
standard for computer security.
Workstation anti-virus: Kaspersky Endpoint Security for Window 11.1.1.126
Individual password to access the computerized data files with a list of authorized persons 
restricted to the 6 persons mentioned above.
Server secured by login + password
PAPER DATA SECURITY
The premises of the Jules Verne clinic have:
-
From an alarm
-
Locking of all offices
-
From a security post
-
Anti-fire device: Fire door, smoke detector
DATA CATEGORIES STORAGE TIME
The following documents will be archived by the name of the study in the premises of the 
service of the Jules Verne clinic from the beginning of the study until the end of the period of 
practical usefulness

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These documents are:
The summary of the study
Information forms and original signed non-objection collections
Individual data (authenticated copies of raw data)
Statistical analyzes
Final report of the study
At the end of the period of practical usefulness, all the documents to be archived at the Jules 
Verne clinic and will be kept under the responsibility of Héloïse de Neuville for 3 years after 
the end of the study in accordance with institutional practices.
No displacement or destruction can be carried out without the agreement of the Promoter 
(Ophtalliance SELARL). At the end of the 3 years, the promoter will be consulted for 
destruction. All data, documents and reports are subject to audit or inspection.
AUDIT AND INSPECTION
An audit carried out at the request of the sponsor or an inspection carried out by the health 
authorities may be carried out at any time by persons independent of those responsible for the 
research. Its objective is to ensure the quality of research, the validity of its results and 
compliance with the law and regulations in force.
Auditors/inspectors should have direct access to source and medical data and any useful 
document related to the conduct of the clinical study.
The confidentiality of the data and the anonymity of the subjects will then be respected.
Investigators agree to abide by the Sponsor's requirements and the authority competent with 
regard to a research audit or inspection.

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The audit may apply to all stages of the research, from the development of the protocol to the 
publication of the results and the classification of the data used or produced within the 
framework of the research.
CERTIFICATE
I hereby certify on behalf of the promoter (SELARL Ophtalliance) that the research entitled: 
Study of Anesthesia by Lidocaine Gel for IntrA vitreous injections, whose principal investigator 
is Dr JF Le Rouic is designed and carried out in accordance with the legal and regulatory 
-884 of May 9, 2017 modifying certain regulatory provisions 
Done in Nantes on June 03, 2022
BARRUCAND Anne
Methodologist- biostatistician
Jules Verne West Ophthalmological Institute Clinical 
Research Department
2/4 route de Paris 
44000 Nantes

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