Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
Conditions: Cataract
Sponsor: SAV-IOL SA



Evaluation of efficacy and long-term safety for Lucidis 
Instant Focus© - PMCF Study protocol 
 
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Table of protocol changes 
 
Versions 
Dates 
Changes 
V1 
20 DEC 2018 
Initial version 
V2 
23 JAN 2019 
Address and responsibilities - Precisions in number 
of patients, follow up and monitoring – Budget 
V3 
20 MAY 2019 
Budget update - Study duration update – Precisions 
in chapters 1.2, 1.3, 2.2, 4.3, 5, 7.1 & 7.2 
V4 
15 JUL 2019 
Precisions about data collection and analysis 7.1, 7.2 
V5 
15 OCT 2019 
Precisions in data collection in chap. 4.3 and addition 
of visits summary table in chap 4.4, review of 
adverse events definitions and procedure in chap 6. 
V6 
06-DEC-2019 
Corrections following investigators review in chap 
1.3, 2.2, 2.6, 3.2, 4.3.2, 4.3.3, 4.4, 4.7, 6.1, 7.1, 7.3 
and 8.1. Update of chap. 11. 
V7 
28-JAN-2020 
Update of signatories 
V8 
24-FEB-2020 
Extension of inclusion period 
V9 
04-NOV-2020 
New principal investigator (2.3, 6.2.1, 12) 
Corrections following Ethic committee review:  
Update of first page with research legislation type as 
HRO and risk category A, 3.1, 3.2, 4.3, 4.4 (update 
of table of collected data), 7.1, 7.2, 7.3, 8.3, 8.4, 8.5, 
8.7, 9, 11 
In chap 8.3: Replacement of EU medical devices 
directive 93/42/EEC by the Regulation 2017/745. 
 
 

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TABLE OF CONTENTS 
Contents 
1 
INTRODUCTION .............................................................................................................. 5 
1.1 
Background .................................................................................................................. 5 
1.2 
Study Rationale............................................................................................................ 5 
1.3 
Benefit risk ratio .......................................................................................................... 6 
2 
STUDY DESIGN ............................................................................................................... 8 
2.1 
Project title ................................................................................................................... 8 
2.2 
Study design ................................................................................................................ 8 
2.3 
Investigator .................................................................................................................. 8 
2.4 
Sponsor ........................................................................................................................ 8 
2.5 
Facilities....................................................................................................................... 8 
2.6 
Study duration.............................................................................................................. 8 
3 
SELECTION OF PATIENTS ............................................................................................ 9 
3.1 
Patient selection method .............................................................................................. 9 
3.2 
Selection Criteria ......................................................................................................... 9 
3.3 
Non-inclusion criteria ................................................................................................ 10 
4 
PRACTICAL IMPLEMENTATION OF THE STUDY .................................................. 10 
4.1 
Study initiation .......................................................................................................... 10 
4.2 
Treatment ................................................................................................................... 11 
4.3 
List of data collected .................................................................................................. 11 
4.3.1 
Data collected at inclusion: ................................................................................ 11 
4.3.2 
Data collected at baseline visit (pre-operative): ................................................. 11 
4.3.3 
Data collected on the day of surgery: ................................................................. 11 
4.3.4 
Data collected after surgery at day 1: ................................................................. 11 
4.3.5 
Data collected after surgery (at week 1, month 1, month 6, year 1): ................. 12 
4.4 
Evaluation schedule ................................................................................................... 12 
4.5 
Patients lost to follow-up ........................................................................................... 14 
4.6 
End of study - withdrawal from the study ................................................................. 15 
4.7 
Monitoring ................................................................................................................. 15 
5 
ASSESSMENT METHODS ............................................................................................ 15 
6 
ADVERSE EVENTS ....................................................................................................... 16 
6.1 
Definitions ................................................................................................................. 16 

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6.1.1 
Definition and classification of adverse events: ................................................. 16 
6.1.2 
Causal relationship of adverse event .................................................................. 17 
6.1.3 
Severity of the adverse event ............................................................................. 17 
6.2 
Procedures ................................................................................................................. 17 
6.2.1 
Serious adverse events and pregnancy ............................................................... 17 
6.2.2 
Other adverse events .......................................................................................... 18 
7 
DATA COLLECTION AND ANALYSIS ...................................................................... 18 
7.1 
Data collection ........................................................................................................... 18 
7.2 
Statistical analysis...................................................................................................... 18 
7.3 
Required sample size ................................................................................................. 19 
8 
ETHICAL AND LEGAL CONSIDERATIONS ............................................................. 20 
8.1 
Medical-regulatory framework of the study .............................................................. 20 
8.2 
Investigator's responsibilities ..................................................................................... 20 
8.3 
Ethics committee ....................................................................................................... 20 
8.4 
Patient information leaflet and informed consent form ............................................. 21 
8.5 
Protection of personal data ........................................................................................ 22 
8.6 
Premature discontinuation of the study ..................................................................... 22 
8.7 
Record keeping / archiving ........................................................................................ 22 
8.8 
Quality assurance - audit procedures ......................................................................... 23 
9 
USE OF RESULTS .......................................................................................................... 23 
10 FINANCIAL ASPECTS .................................................................................................. 23 
10.1 
Investigator fees ..................................................................................................... 23 
10.2 
Sponsor fees ........................................................................................................... 23 
10.3 
Additional costs ..................................................................................................... 24 
11 SCHEDULE ..................................................................................................................... 25 
12 SIGNATURES ................................................................................................................. 25 
 
 
 

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1 INTRODUCTION 
 
1.1 Background 
Refractory function in patients with a cataract is mainly restored by implanting intra-
ocular lenses (IOL) destined to replace the crystalline lens. While new surgical 
techniques for removing the crystalline lens have been developed, these lenses have 
been considerably perfected to resemble the natural crystalline lens as closely as 
possible. 
 
Since December 2015, SAV-IOL SA got the CE marking with lenses which have the 
potential to obtain the best results in terms of visual acuity and comfort. Both are 
benefiting from the Instant Focus © technology (legal manufacturer SAV-IOL-SA 
www.sav-iol.com) 
• The lens InFo is a refractive/diffractive hybrid lens characterized by 
extended depth of focus to guarantee satisfactory vision, regardless of 
focal length and light conditions. This benefit is particularly apparent 
for intermediate vision, significantly improved relative to multifocal 
optics that only allow focus on objects in near and far vision, without 
any usual adverse events met with that multi/polyfocal lenses 
• The lens Lucidis is a refractive lens with an extended depth of focus to 
get satisfactory vision, regardless of focal length and light conditions. 
This benefit is particularly apparent for far vision, with additional view 
for near and intermediate vision. Lucidis is proposed in 2 sizes : 10.8 
mm (Lucidis 108M) & 12.4 mm (Lucidis 124M) diameter, containing 
the same optical size (6.0 mm diameter). 
 
1.2 Study Rationale 
 
The objectives of the study is to evaluate efficacy and long-term safety of the 
Lucidis lens. Through this PMCF (post marketing clinical follow-up), the objective is 
to obtain an up-to-date clinical evaluation of the medical device thus supplementing 
data from experimental trials.  Clinical and functional changes in the implanted eyes 
among a patient population in which the opaque crystalline lens resulting from 
cataract was removed and replaced by a Lucidis IOL will be described.  
 
The objectives involve both evaluation of changes in ocular function in terms of visual 
acuity and comfort and listing possible complications of surgery and adverse 
reactions. 
 
 

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Study primary objectives – measure of: 
• Far Best Corrected Visual Acuity in photopic conditions  
• Near, intermediate and far Uncorrected visual acuity in photopic 
conditions 
• Far Best Corrected Visual Acuity in mesopic conditions 
• Near, intermediate and far Uncorrected visual acuity in mesopic 
conditions 
 
Study secondary objectives – measure of: 
• Contrast sensitivity in photopic conditions 
• Contrast sensitivity in mesopic conditions 
• Adverse reactions. 
 
1.3 Benefit risk ratio 
Contraindications for intraocular lens are previous pathologies or physiological 
conditions, which may be aggravated by the lens, or in cases where the lens may 
interfere with the possibility of examining or treating diseases. 
• Acute eye diseases or external or internal infection 
• Fuchs’ proliferative diabetic retinopathy 
• Severe corneal dystrophy 
• High myopia 
• Chronic or recurrent severe uveitis 
• Severe optic nerve atrophy 
• Congenital bilateral cataracts or non-age-related cataract 
• Glaucoma 
• Choroidal hemorrhage 
• Color vision deficiencies 
• Irregular corneal astigmatism 
• Extremely shallow anterior chamber 
• Severe Microphthalmos or Macrophthalmos 
• Aniridia 
• Retinal Detachment 
• Macular degeneration 
• Micropupil 
Severe complications during surgery might be: 
• Choroidal hemorrhage 
• Vitreous loss  
 
 

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Adverse reactions and complications due to, or following surgery and, implantation of 
any intraocular lens may include, but are not limited to: 
• Increased Astigmatism 
• Corneal Decompensation 
• Vitritis 
• Loss of Best Spectacle Corrected Visual Acuity 
• Lens Dislocation 
• Lens Vault 
• Anterior Subcapsular Cataract 
• Macular Edema 
• Iritis 
• Decentration/Rotation of the InFo lens 
• Non-reactive Pupil 
• Uveitis 
• Secondary Surgical Intervention to remove/Replace lens 
• Pupillary Block Glaucoma IOP > 5mmHg over baseline and IOP > 
25mmHg 
• Corneal Edema 
• Retinal Detachment 
• Corneal Endothelial Cell Loss 
• Secondary Glaucoma 
• Hyphema 
• Synechiae to Implant 
• Hypopyon 
• Under/Over correction 
• Severe Intraocular Inflammation 
• Significant Glare and/or Halos around lights 
• Intraocular Infection 
• Vitreous Loss 
The benefit for the patient is the treatment of its cataract and improvement of his 
visual acuity. 
 
Before implanting the Lucidis lens with any of the following conditions, pre-operative 
evaluation should be performed by a surgeon to consider the potential benefit/risk 
ratio. 
 
The patients included in this observational study are planned for surgery with Lucidis 
lens implantation. There is no additional risk or benefit for them participating to this 
post-market follow-up study. 
 

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2 STUDY DESIGN 
2.1 Project title 
 
Evaluation of efficacy and long-term safety of Lucidis Lenses / PMCF. 
 
2.2 Study design 
 
This is a monocentric, longitudinal, prospective, cohort study for a population 
of 120 eyes on 60 to 120 patients (depending on mono or bi-lateral surgery 
conditions) with a cataract, receiving an Lucidis lens implant. After the cataract 
procedure, data collection will take place during appointments planned by the 
physician (after one day, one week, one month, six months and one year).  
 
2.3 Investigator 
 
Dr Kate Hashemi  
Institution Jules Gonin Eye Hospital / Fondation Asile des Aveugles 
Avenue de France 15, Lausanne, Switzerland 
 
2.4 Sponsor 
 
Dr Max Boysset - CEO SAV-IOL SA, Falaises 74, 2000 Neuchatel 
 
2.5 Facilities 
Institution Jules Gonin Eye Hospital / Fondation Asile des Aveugles 
Avenue de France 15, Lausanne, Switzerland 
 
2.6 Study duration 
 
Provisional total duration of the study: 21 months (nine-months inclusion 
period + 1-year follow-up period). 
 
All included patients will be followed up for a period of one-year nominal. The 
participating physicians will be given a period of nine months to enroll patients. The 
study will be completed as soon as the last patient included has undergone an 
evaluation of one year after inclusion in the study.  
 
An interim statistical analysis will be performed after the last patient has undergone 
its 6 months follow-up.  Data obtained from all included patients, up to the 6-months 
follow-up, will be used to write this interim report.  
 
 

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3 SELECTION OF PATIENTS  
3.1 Patient selection method 
Once the study has been initiated, the investigator will recruit the 60 to 120 patients 
(120 eyes) in an expected period of 6 months. The inclusion period will end at the 
inclusion of the last patient. 
 
During this period, the investigator will invite all patients for whom the decision has 
been made to implant a Lucidis lens to take part in the study, so as to include all 
patients fulfilling the study inclusion criteria in a consecutive manner. 
Prior to inclusion and before carrying out any study-related procedures, the 
investigator will first inform each patient of the study objectives, the conditions for 
their participation in the study, and the need to allow the study monitor to have direct 
access to their medical records. Patients will be given an information leaflet and 
informed consent form, which they are required to personally date and sign.  
 
Before implanting the Lucidis lenses with any of the following conditions, pre-
operative evaluation is performed by the surgeon to consider the potential benefit/risk 
ratio. In case of contraindications, ie the patient already has pathologies or 
physiological conditions, which may be aggravated by the lens, or in cases where the 
lens may interfere with the possibility of examining or treating diseases, the lens will 
not be implanted and the patient will not be included in the study. 
Additionally to exclusion criteria, the risk/benefit ratio is individually assessed for 
each patient with regards to safety and patient vision performance expectations. 
Diagnostic, anamnesis, eye biometry combined with way of life and patient 
expectations are considered prior the selection by the surgeon or proposal to the 
patient to implant a Lucidis IOL. Lucidis is an EDOF (Extended Depth Of Focus) 
intraocular lens that provides near and intermediate vision in addition to distance 
vision. Should a patient’s medical status or visual expectations determined as not in 
adequacy with the device, alternative available devices - such as monofocal or 
multifocal intraocular lenses would be implanted instead. The choice of the 
intraocular lens based on the state of the art is an essential parameter evaluated in 
depth by the physician (through diagnosis, anamnesis, comorbidities, biometry, 
lenses optical performances, dysphotopsia, patient way of life and expectations, 
etc.). 
3.2 Selection Criteria 
• adult patients (≥18 years) 
• having agreed to take part in the study and complete post-operative 
follow-up requirements (by having signed the information leaflet-informed 
consent form); 
• significant reduction in visual acuity and/or visual comfort from cataract; 

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• for whom the physician made the decision to implant a Lucidis based on 
medical considerations.  
 
3.3 Non-inclusion criteria 
The following will not be included in the study: 
• patient included in an interventional therapeutic trial at the time of 
inclusion; 
• patient presenting contraindications for the implantation of an intraocular 
lens; 
• patient presenting an ophthalmic disorder liable to interfere with the study 
endpoints; 
• patient presenting with an astigmatism ≥1.0 D; 
• patient refusing or unable to comply with the follow-up procedures in the 
study (patient unable to be reached by telephone, liable to be lost to 
follow-up, etc.); 
• History of previous intraocular surgery in the study eye in the previous 6 
months; 
• patient is pregnant, breast-feeding or unable to make the decision to 
participate in a clinical investigation (e.g. mentally ill or handicapped 
person) 
4 PRACTICAL IMPLEMENTATION OF THE STUDY 
This study does not affect the physician-patient relationship, or usual patient 
management. The physicians remain free in their prescribing and follow-up practices; 
no specific procedures or examinations are requested. The study remains within the 
normal treatment context.  
 
4.1 Study initiation 
Before the first patient is included in the study, the study protocol, case report forms 
and completion guidelines, the procedure for obtaining informed consent, together 
with the procedure for reporting adverse events will be explained to the investigator 
during the initiation visit. 
 
 

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4.2 Treatment 
The surgical procedures for implanting the lens are left to the discretion of the 
investigator according to his/her practices. All treatments administered in the context 
of implantation should also be reported in the "concomitant medication" section of the 
CRF. 
 
4.3 List of data collected 
The physician will fill in a paper case report form (p-CRF) for each patient’s eye, 
comprising: 
4.3.1 Data collected at inclusion: 
• Date of inclusion; 
• Verification of inclusion and exclusion criteria; 
• Declaration by the physician that the patient has signed the information 
leaflet and informed consent form; 
• Demographic data (age at inclusion, gender); 
• Candidate eye for operation (uni- or bilateral in nature) 
4.3.2 Data collected at baseline visit (pre-operative): 
• Cataract history: age of onset, type of cataract; 
• Pre-operative 
ophthalmological 
examination: 
standard 
slit-lamp 
examination, 
visual 
acuity 
in 
photopic 
and 
mesopic 
conditions 
(uncorrected visual acuity for near, intermediate (80cm), and far vision & 
best corrected visual acuity for far vision), contrast sensitivity and 
aberrometry.  
4.3.3 Data collected on the day of surgery:  
• Operated eye 
• Lens information 
• General surgical procedure information (Constant value including formula 
biometry, type of anaesthesia, incision site). The choice of the formula is 
left to the discretion of the investigator. However, it shall be the same for 
all patients. 
• Adverse event during surgery 
4.3.4 Data collected after surgery at day 1: 
• Postoperative 
ophthalmological 
examination: 
standard 
slit-lamp 
examination, 
visual 
acuity 
in 
photopic 
and 
mesopic 
conditions 
(uncorrected visual acuity for near, intermediate (80cm), and far vision & 

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best corrected visual acuity for far vision), contrast sensitivity, aberrometry 
and defocus (defocus will be measured for the first 40 patients as a 
minimum) at the discretion of the investigator.  
• Adverse events spontaneously reported by the patient; 
• Specific interview concerning visual acuity, frequency of glare and halo, 
distorted vision. 
• Possible postoperative complications 
• Change in medication intake 
 
4.3.5 Data collected after surgery (at week 1, month 1, month 6, year 1): 
• Postoperative 
ophthalmological 
examination: 
standard 
slit-lamp 
examination, 
visual 
acuity 
in 
photopic 
and 
mesopic 
conditions 
(uncorrected visual acuity for near, intermediate (80cm), and far vision & 
best corrected visual acuity for far vision), contrast sensitivity, aberrometry 
and defocus (defocus will be measured for the first 40 patients as a 
minimum).  
• Adverse events spontaneously reported by the patient; 
• Specific interview concerning visual acuity, frequency of glare and halo, 
distorted vision. 
• Possible postoperative complications 
• Change in medication intake 
 
4.4 Evaluation schedule 
The initial evaluation during the inclusion and baseline visit is done from 1 to 14 days 
before the date of surgery.  
 
The evaluation schedule will then correspond as follows, for each eye:  
• Day of surgery 
• Day 1 (0 to 3 days after surgery) 
• Week 1 (7 to 10 days after surgery) 
• Month 1 (30 to 45 days after surgery) 
• Month 6 (180 to 195 days after surgery) 
• Year 1 (360 to 390 days after surgery).  
 
If it is not possible to perform a visit, it must be documented and justified on the p-
CRF. See also chapter 4.5 for lost patients follow-up. 
 

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In case of bilateral surgery, the Month 6 and Year 1 follow-up visits of each eye can 
be combined together into 1 visit, if within the timeframe. After the second eye’s 
surgery, visual acuities are additionally measured as bilateral.     
 
 

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Collected data 
Screenin
g (study 
inclusion 
Baseline 
visit  
(D - 14-1) 
Surgical 
procedure 
(D) 
Follow-up Day 1 
(D1-2) 
Follow-up Week 1 (D7-10)  
Follow-up Month 1 (D30-45) 
Follow-up Month 6 (D180-195)2 
Follow-up Year 1 (D360-390)2 
Informed consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Inclusion / exclusion criteria 
X 
 
 
 
 
Candidate eye(s) for operation 
X 
 
 
 
 
Slit lamp examination 
 
X 
 
X1 
X 
Cataract history 
 
X 
 
 
 
Contrast sensitivity 
Photopic (85–100 lx) and 
Mesopic (3 lx) 
 
X 
 
X1 
X 
Uncorrected Visual Acuity – Far 
Photopic (85–100 lx) and 
Mesopic (3 lx) 
 
X 
 
X1 
X 
Uncorrected Visual Acuity – 
Intermediate 
Photopic (85–100 lx) and 
Mesopic (3 lx) 
 
X 
 
X1 
X 
Uncorrected Visual Acuity – Near 
Photopic (85–100 lx) and 
Mesopic (3 lx) 
 
X 
 
X1 
X 
Best Corrected Visual Acuity - Far 
 
X 
 
X1 
X 
Defocus curve* 
Photopic 
(85–100 
lx) 
and 
Mesopic (3 lx) 
 
X 
 
X1 
X 
Abberometry 
 
X 
 
X1 
X 
Operated eye 
 
 
X 
 
 
Lens information 
 
 
X 
 
 
General surgical procedure 
information  
 
 
X 
 
 
Adverse event during surgery 
 
 
X 
 
 
Adverse 
event 
spontaneously 
reported by patient 
 
 
 
X 
X 
Specific interview: visual acuity, 
frequency of glare and halo, 
distorted vision 
 
 
 
X 
X 
Change in medication intake 
 
 
 
X 
X 
*only for the first 40 patients. In case of patient withdrawal, data will be collected on a new 
patient to obtain data on a minimum 40 patients, whenever possible. 
X1: at the discretion of the investigator 
2: Additional follow up visits compared to standard procedure 
 
4.5 Patients lost to follow-up 
A patient will be considered lost to follow-up if s/he does not attend a scheduled visit 
and if the investigating physician is unable to obtain any news on the patient in the 
next two months after making every attempt to contact the patient. 
 

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During contact, the investigating physician will ask the patient about the reasons for 
not attending the scheduled visit (moved house, personal decision for example) and 
his/her decision regarding participation in the study and continued management. 
 
4.6 End of study - withdrawal from the study 
The patients will be considered to have completed the study after they have 
undergone a final evaluation 1 year after the inclusion visit. 
 
The following may be considered to have withdrawn from the study: 
• Patients who have requested to do so (verbal or written) via the 
investigator; 
• patients lost to follow-up by the center, unable to be reached; 
• Included patients presenting an exclusion criterion during the study (for 
example, inclusion in an interventional therapeutic trial). 
 
In case of withdrawal of informed consent, non-compliance, disease progression, 
safety, etc. the study procedures might be stopped but the routine follow-up should 
be performed due to safety concerns. Data previously obtained will be retained and 
analyzed. 
 
4.7 Monitoring 
The sponsor, or an individual independent from the study and appointed by the 
sponsor, will perform monitoring visits, at study initiation, after one of the evaluation 
schedule and at study completion, as a minimum, to oversee progress in accordance 
with this protocol. 
 
5 ASSESSMENT METHODS 
At each visit the patient will be seen by both an ophthalmologist and an optometrist. 
The qualified optometrist will carry out all examinations regarding visual acuity, 
contrast sensitivity and aberrometry. The investigating ophthalmologist will collect 
data through slit-lamp examination, and through interviewing the patient about any 
unusual sensations or adverse events based on the patient's impressions, 
observations and response to the question: "How are you feeling?" or "How have you 
felt since the last visit?". Adverse events will be recorded. An anomaly persisting at 
the end of the study will be monitored by the investigator until they resolve or at least 
stabilize. 
 
 

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6 ADVERSE EVENTS 
6.1 Definitions 
6.1.1 Definition and classification of adverse events: 
An adverse event is a harmful occurrence in a person taking part in a biomedical 
study, whether or not this event is related to the study or study product. An adverse 
event can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of the 
product, whether or not this is considered to be related to the use of the product 
(International Conference on Harmonisation, ICH). 
 
A serious adverse event (SAE) is an event which: 
• results in death; 
• is life-threatening to the person taking part in the study; 
• requires inpatient hospitalization (≥ 24 hrs) or prolongation of existing 
hospitalization; 
• results in persistent or significant disability/incapacity; 
• or is a congenital anomaly/birth defect. 
 
A life-threatening risk is an event which places the subject at immediate risk of death 
at the time of the event; this does not refer to an event which hypothetically may have 
caused death if it were more severe. 
 
Any medically significant event which, according to the assessment based on the 
investigator's medical and scientific knowledge, while not immediately life-
threatening, may result in the death of the patient, require inpatient hospitalization, 
endanger the patient, require medical or surgical intervention to prevent progression 
to one of the above-mentioned situations, should be perceived as serious. 
 
Temporary transfer to a hospital outpatient clinic, an admission’s department or day 
hospital (< 24 hrs) or inclusion in a home hospitalization system not leading to 
administrative hospital stay measures, is not perceived as hospitalization. 
 
Any hospitalization occurring during a study should be reported to the sponsor by the 
investigator (as soon as it is brought to his/her attention). 
 
Therefore, the following types of hospitalization are not subject to declaration: 
required surgical intervention planned prior to inclusion in the study, for investigations 
stipulated in the protocol, as a simple precautionary measure for monitoring after 
overdose in a patient not presenting any clinical, paraclinical or laboratory anomalies, 
or related to specific social circumstances affecting the patient. Any pregnancies 
during the study will be considered an SAE. 
 

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Unexpected adverse event: any event the nature or severity of which is not in the 
product instruction for use. 
 
6.1.2 Causal relationship of adverse event 
The causal relationship of the adverse event should be based on the following 
classification: 
• device related: potential imputability with the device 
• surgery related: potential imputability with the surgical procedure 
• other. 
 
6.1.3 Severity of the adverse event 
The severity of the adverse event should be based on the following classification: 
• mild: generally transient, does not affect the patient's normal daily 
activities; 
• moderate: interferes with the patient's daily activities and/or sleep; 
• severe: prevents the patient's daily activities and/or sleep. 
 
6.2 Procedures 
6.2.1 Serious adverse events and pregnancy 
Serious events are not expected in the context of this study, which is the treatment of 
cataract. 
 
However, in case of serious adverse events and/or pregnancies occurring during the 
study, must be reported to the study sponsor by fax or mail within 24 hours of the 
event being notified. This report must be signed and dated by the investigator and 
faxed or mailed to: 
 
Dr. Max Boysset 
Fax: +41 32 566 54 01 
Mail: Max Boysset max.boysset@sav-iol.com 
 
and copy to: 
 
Dr Kate Hashemi 
Mail: kattayoon.hashemi@fa2.ch 
 
Serious adverse events which have not resolved at the end of the study should be 
monitored by the investigator until they are resolved (or become consolidated) or until 

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there is evidence that there is no relationship between the event and the study 
conditions or until it is firmly believed that no additional information can be obtained. 
 
6.2.2 Other adverse events 
Non-serious adverse events (including exacerbation of existing disorders) should be 
reported on the p-CRF regardless of their causal relationship, from the signing of the 
information leaflet and informed consent form until the end of the last study 
procedure. 
 
Investigators should give their own opinion on the relation between the event and the 
lens implant, describe all the measures taken as a result of the event as well as the 
event outcome in the p-CRF. 
 
The sponsor is responsible for the appropriate reporting of adverse events to the 
authorities and the Ethics Committee that approved the protocol. 
7 DATA COLLECTION AND ANALYSIS 
7.1 Data collection 
The investigator will receive a case report form (p-CRF) paper format for each patient 
for recording the evaluation results. Collected data on p-CRF will be used as source 
data. In case of bilateral surgery, one case report form will be completed for each eye 
which include bilateral visual acuity 
Each patient will be assigned an identification number. The sponsor will review case 
report forms and collected data will be entered in Excel file at specific time (for 
example after monitoring visits) by an independent individual appointed by the 
sponsor. The entered data will be checked by another person. Then the completed 
cells on the Excel spreadsheet will be blocked and the document printed. The printed 
record must be dated and signed. The printed record will be added to the study input 
documentation. This file will be maintained by the sponsor who will ensure that it is 
valid and secure.  
 
7.2 Statistical analysis 
The analysis will be comparative and shall concern all patients having agreed to take 
part in the study. Statistical data will be evaluated for each eye, additionnaly in case 
of bilateral surgery visual acuity for both eyes will be analysed for each eye and 
together. The quantitative variables will be described in terms of sample size, mean, 
standard deviation, median, range and missing data. The qualitative variables will be 
described in terms of sample size, percentage and missing data. Two-sided 95% 
confidence intervals will be provided if the endpoint is considered relevant. Wilcoxon 
and Student significance tests will be used. 

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An interim statistical analysis will be performed from the 6 months data of all included 
patients. A final statistical analysis will be performed after the last 1-year follow-up 
visit of the last patient. Data will be compared to the state of the art data regarding 
similar lenses available on the market. 
 
7.3 Required sample size 
The total number of eyes to be included in the study is 120. Indeed, based on the 
statistical calculations and standards described in ISO 11979-7:2018 regarding 
clinical investigations for ophthalmic implants, intraocular lenses, it is considered that 
100 eyes would be sufficient to detect the appearance of any post-operative 
complications, at a statistically satisfactory rate of probability, and to discriminate the 
visual acuity results.  
 
 

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8 ETHICAL AND LEGAL CONSIDERATIONS 
8.1 Medical-regulatory framework of the study 
The procedures described in this protocol, concerning the implementation, evaluation 
and documentation of the study are designed to ensure that the sponsor and 
investigating physician comply with the ethical principles defined in the Declaration of 
Helsinki and with the Good Clinical Practice according to the standard ISO 14155: 
2011.  
 
The study will be conducted in compliance with Swiss Law and Swiss regulatory 
authority’s requirements and European regulatory requirements and legislation. 
 
This observational study does not require additional biological samples of any type 
whatsoever, other than those normally prescribed by the physician. Except for 2 
additional follow-up visits (month 6 and Year 1) and additional examination under 
mesopic conditions, it does not change the way in which the physician manages the 
patient. 
 
8.2 Investigator's responsibilities 
The investigator is responsible for ensuring that the study is conducted in accordance 
with Good Clinical Practice (GCP) guidelines as well as all the regulations governing 
the conduct of clinical trials in Switzerland. 
 
Good Clinical Practice (GCP) guidelines aim to protect the rights, safety and welfare 
of persons taking part in research, together with the credibility and confidentiality of 
personal data and the study results. GCP are international standards of ethical and 
scientific quality concerning the development, conduct, recording and reporting of 
studies involving human participants. 
 
Compliance with these reference standards provides assurance that the rights, 
safety, protection and well-being of patients in the study will be respected in 
accordance with the principles laid down in the Declaration of Helsinki, and that the 
clinical study data are reliable (genuine, precise and accurate). 
 
8.3 Ethics committee 
The present protocol was drawn up based on the generic standard ISO 14155:2011 
(Clinical investigation of medical devices for human subjects. Good clinical practice). 
 
EU Regulation 2017/745, concerning medical devices was taken into account, 
together with the Federal Act on medicinal products and medical devices (Act on 
therapeutic products) and the ordinance on clinical trials on therapeutic products. 
 

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This study can only be undertaken after approval of the protocol and appendices has 
been obtained from the relevant Ethics Committee. During the study, the following 
documents must be submitted to the Ethics Committee for review: 
 
• Any amendments to the protocol 
• Any changes to the information leaflet and informed consent form or any 
document to be given to the patient. 
• All cases of SAEs related to the lens implant 
• new investigator notification 
• any new information concerning the safety of the device or which may 
interfere with the conduct of the study 
• protocol deviations which may affect the results of the study. 
 
During the study, amendments to the protocol which alter the risks and obligations of 
the patients, amendments and revisions made to the information leaflet and informed 
consent form, together with any substantial amendments must be promptly submitted 
to the Ethics Committee for review and approval prior to implementing any such 
changes.  
 
At the end of the study, the sponsor shall notify the Ethics Committee of the end of 
the study, then send it the safety report, together with a summary of the study report. 
 
8.4 Patient information leaflet and informed consent form 
Each patient must give his/her written informed consent after receiving a full 
explanation about the nature of the study. The consent form (the content of which 
has been approved by the Ethics Committee) must be dated and signed prior to the 
execution of any study-related procedures. 
 
Before enrolment in the study, the investigator must explain the nature of the study 
and the consequences of their participation to the selected patients. Patients must be 
informed about the voluntary nature of their participation and their right to withdraw 
their consent at any time without affecting the quality of their future care in any way. 
They will be informed that alternative treatments are available should they refuse to 
take part in the study. Finally, they must be informed that the competent authorities 
and sponsor's representatives may have access to their personal study data, but that 
the confidentiality of this information will be respected according to current laws and 
regulations. The patient must be given sufficient time to read the informed consent 
form and to ask further questions. 
 
After signature, a copy of the information leaflet and informed consent form will be 
given to the patient and a copy will be kept by the investigator on the investigation 
site. 
 

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The participation to the study will not generate additional cost to the patient or their 
health insurance. The sponsor will reimburse the additional visits based on proof of 
invoice for the following eligible costs: 
• Outward and return trip from the place of residence to the investigator 
o Car: 70cts / km 
o Train: actual cost in second class 
o Taxis: Actual costs up to a maximum of CHF 50 per trip 
o Medicalized car: costs not covered by health insurance reimbursed 
o Ambulance / not reasonably mobile: not reimbursed and/or withdrawal 
from the study 
The cost refund by the sponsor will be made through the investigation center, the 
investigation center will provide the refund directly to the patient as the sponsor must 
not have access to patient’s personal data.  
8.5 Protection of personal data 
In compliance with Swissmedic recommendations and “Swissethics” Ethics 
Committee Working Group guidelines, the collection and processing of data 
concerning the patients included in the study will only concern those data required for 
the implementation of the trial. The patients' names must not be communicated to the 
sponsor only the investigator will have access to the code. The sponsor will not have 
access to patient’s personal data, only the patient number will be shown in the CRFs. 
Technical measures and appropriate organization are planned to protect personal 
data against unauthorized disclosure or access, destruction or accidental or unlawful 
alteration of data. Patients have the right to request access to their personal data 
through the investigator and the right to rectify any incorrect or incomplete data. 
 
8.6 Premature discontinuation of the study 
The sponsor or investigating physician may discontinue the study at any time. This 
discontinuation should take place, if possible, after mutual dialogue. 
 
If the study were prematurely discontinued, all study materials (including data 
collection forms, whether completely, partly completed or blank) should be returned 
to the medical device company sponsoring the study. 
 
8.7 Record keeping / archiving  
The sponsor will register the study before carrying out the study in 
www.clinicaltrial.gov.  
 
All study data must be archived for a minimum of 15 years after study termination or 
premature termination of the clinical study. 
 
Records will be located and stored on the clinical investigation center of: 
Institution Jules Gonin Eye Hospital / Fondation Asile des Aveugles 

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Avenue de France 15, Lausanne, Switzerland 
 
8.8 Quality assurance - audit procedures 
In compliance with Good Clinical Practice (GCP) guidelines, the investigating 
physician agrees to a possible audit by an individual whose involvement in the study 
is limited to this role only. 
 
This individual is either: 
• A Quality Assurance representative from the medical device company 
acting as the sponsor; 
• An individual independent from the study and appointed by the medical 
device company acting as the sponsor; 
• A representative from competent authorities. 
 
At the request of medical device company acting as the sponsor, a Clinical Research 
Associate may also carry out random audits at the center. Quality control applies to 
all stages of the study, from developing the summary document to publication of the 
results and filing of the data used or generated in the context of the study. 
 
9 USE OF RESULTS 
All information and scientific data relating to the products and collected in the context 
of this study are considered confidential. The result of the study can be submitted (by 
the investigator or the sponsor) for publication or presentation to a health authority or 
scientific gathering without prior authorization from the investigator and the sponsor 
initiating the study. 
 
10 FINANCIAL ASPECTS 
 
10.1 Investigator fees 
 
The sponsor will pay a fee to the investigator per surgery of 1740 CHF exc. 
VAT on a 120 lenses basis (total number of lenses provided). 
 
10.2 Sponsor fees 
 
The sponsor delivers 120 lenses to the investigator free of charge. 

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10.3 Additional costs 
 
Additional costs of 10,000 CHF are accrued, including diverse professional 
services, publication costs, to the charge of the sponsor. 
 
 

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11 SCHEDULE 
 
Activities 
Dates 
Study start day 
January 2021 – subject to ethical committee 
approval 
End of enrolment 
October 2021 
Submission of report 
February 2022 
Use of findings (abstracts, posters, articles) 
TBD 
 
12 SIGNATURES 
SAV-IOL SA, Falaises 74, 2000 Neuchâtel, 
Switzerland, CHE-114.948.271 
Dr Max Boysset 
Chief Executive Officer 
 
 
 
On the first hand, and 
 
 
 
Exercising in Institution Jules Gonin Eye 
Hospital / Fondation Asile des Aveugles, 
Avenue de France 15, Lausanne, Switzerland, 
CHE-109.382.412  
Dr Kate Hashemi Principal Investigator 
 
 
On the second hand