CT Lucia 601 IOL Implantation in the Sulcus
Conditions: Cataract; Complicata, Posterior Capsule Tear, Lens Dislocation
Sponsor: Universitaire Ziekenhuizen KU Leuven

 
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Clinical Investigation Title: CT Lucia 601 IOL implantation in the sulcus 
The CT Lucia in the sulcus study is a non-commercial (academic with study grant), 
monocentric, post-interventional observational without use of a study drug. 
 
Clinical Investigation Acronym: CTLucia in the sulcus 
 
 
Sponsor 
UZ Leuven 
Principal Investigator 
Prof. dr. Peter Stalmans 
Sponsor Reference Number 
S64878 
Version Number and Date 
CLus study Version 3 08022021 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone 
other than the Sponsor, the Investigator Team, regulatory authorities, and members of 
the Research Ethics Committee. 

 
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CLINICAL INVESTIGATION PLAN AUTHORISATION 
 
Principal Investigator 
Name: Peter Stalmans 
Title: prof. dr. 
Signature: 
Date: 
Site: UZ Leuven 
Statistician 
Name: Jean-François Fils, Ars Statistica 
Title: Medical statistician 
Signature: 
Date: 
Sponsor 
Name: UZ Leuven 
Title: 
Signature: 
Date: 

 
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TABLE OF CONTENTS 
 
 
Contents 
1. 
AMENDMENT HISTORY ................................................................................................................... 7 
2. 
List of appendices ........................................................................................................................... 8 
3. 
ABBREVIATIONS .............................................................................................................................. 8 
4. 
CLINICAL INVESTIGATION SUMMARY ............................................................................................. 8 
5. 
INTRODUCTION ............................................................................................................................. 11 
6. 
OBJECTIVES ................................................................................................................................... 12 
7. 
CLINICAL INVESTIGATION DESIGN ................................................................................................ 13 
8. 
CLINICAL INVESTIGATION POPULATION ....................................................................................... 14 
8.1. 
Number of participants ......................................................................................................... 14 
8.2. 
Inclusion criteria .................................................................................................................... 14 
8.3. 
Exclusion criteria ................................................................................................................... 14 
9. 
PARTICIPANT SELECTION AND ENROLMENT ................................................................................ 14 
9.1. 
Identifying participants ......................................................................................................... 14 
9.2. 
Consenting participants ........................................................................................................ 15 
9.3. 
Randomisation ...................................................................................................................... 15 
9.4. 
Withdrawal of participants ................................................................................................... 15 
10. 
Investigational DEVICE .............................................................................................................. 16 
10.1. 
Investigational device details ............................................................................................ 16 
10.2. 
Device manufacturer ......................................................................................................... 17 
10.3. 
Device accountability ........................................................................................................ 17 
10.4. 
Storage conditions ............................................................................................................ 17 
10.5. 
Concomitant Treatments .................................................................................................. 17 
11. 
CLINICAL INVESTIGATION ASSESSMENTS ................................................................................. 17 
11.1. 
Investigation Characteristics ............................................................................................. 17 
11.2. 
Surgical procedure ............................................................................................................ 17 
11.3. 
Safety assessments  .......................................................................................................... 18 
11.4. 
Adverse events do not require reporting ......................................................................... 18 
 
12. 
Data Quality Assurance ............................................................................................................. 18 
12.1. 
Monitoring, Audit and Inspections ................................................................................... 18 
12.2. 
Training of staff ................................................................................................................. 18 

 
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12.3. 
Data Management ............................................................................................................ 18 
13. 
STATISTICS ................................................................................................................................. 19 
13.1. 
Description of statistical methods .................................................................................... 19 
13.2. 
The number of participants .............................................................................................. 19 
13.3. 
The level of statistical significance .................................................................................... 19 
13.4. 
Criteria for the termination of the clinical investigation .................................................. 19 
13.5. 
Procedure for accounting for missing, unused and spurious data ................................... 19 
13.6. 
Procedures for reporting any deviations from the original statistical plan ...................... 19 
13.7. 
Inclusion in analysis ........................................................................................................... 19 
14. 
CLINICAL INVESTIGATION MANAGEMENT ................................................................................ 20 
14.1. 
Clinical investigation management group and parties involved ....................................... 20 
14.2. 
Clinical investigation steering committee ......................................................................... 22 
14.3. 
Data monitoring committee ............................................................................................. 22 
14.4. 
Monitoring plan ................................................................................................................ 22 
15. 
GOOD CLINICAL PRACTICE ........................................................................................................ 23 
15.1. 
Declaration of Helsinki ...................................................................................................... 23 
15.2. 
Guidelines for GCP ............................................................................................................ 23 
15.3. 
Ethics review ..................................................................................................................... 23 
15.4. 
Patient Information and Consent Form ............................................................................ 23 
15.5. 
Subject data protection .................................................................................................... 23 
15.6. 
Procedures in case of medical emergency ........................................................................ 23 
16. 
CLINICAL INVESTIGATION CONDUCT RESPONSIBILITITES ......................................................... 24 
16.1. 
Clinical investigation plan amendments ........................................................................... 24 
16.2. 
Clinical investigation plan violations, deviations and serious breaches ........................... 24 
16.3. 
End of clinical investigation ............................................................................................... 24 
16.4. 
Insurance and indemnity .................................................................................................. 24 
16.5. 
Funding.............................................................................................................................. 24 
17. 
REPORTING, PUBLICATIONS AND NOTIFICATIONS OF RESULTS ............................................... 24 
17.1. 
Authorship policy .............................................................................................................. 24 
17.2. 
Publication ........................................................................................................................ 25 
18. 
REFERENCES .............................................................................................................................. 25 
19. 
SAFETY REPORTING ................................................................................................................... 26 
19.1. 
Definitions ......................................................................................................................... 26 
19.2. 
Procedures for reporting SAE /SADE  or DD that could have led to a SADE ..................... 27 

 
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19.3. 
Procedures for Device Defiency reporting ........................................................................ 27 
19.4. 
Causality Assessment ........................................................................................................ 27 
19.5. 
Recording of safety information ....................................................................................... 27 
19.6. 
Reporting procedure for all SAEs/SADEs ........................................................................... 28 
19.7. 
Annual reports .................................................................................................................. 28 

 
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This CIP describes the investigation of the CT Lucia 601 IOL implantation in the sulcus. 
This paper provides information about procedures for entering participants. Every care was 
taken in its drafting, but corrections or amendments may be necessary. These will be 
circulated to investigators in the clinical investigation. Problems relating to this clinical 
investigation should be referred, in the first instance, to the Principal Investigator. 
This clinical investigation will adhere to the principles outlined in the ISO 14155:2011. It 
will be conducted in compliance with the CIP, the Data Protection Act and other regulatory 
requirements as appropriate. 
 
 

 
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1. AMENDMENT HISTORY 
 
 
Amendment 
No. 
CIP 
Version No. 
Date 
Issued 
Author(s) of 
Changes 
Details of Changes 

 
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2. LIST OF APPENDICES 
 
 
Appendix A 
Investigator’s Brochure 
Appendix B 
Protocol of the study 
Appendix C 
Inform Consent Form 
 
3. ABBREVIATIONS 
 
 
AE 
Adverse Event 
AR 
Adverse Reaction 
BCVA 
best-corrected visual acuity 
CIP 
Clinical Investigation Plan 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
EC 
Ethics Committee (see REC) 
GCP 
Good Clinical Practise 
GP 
General Practitioner 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonisation 
IRB 
Independent Review Board 
Log MAR 
logarithm of the minimal angle of resolution 
PI 
Principle Investigator 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SUSAR 
Suspected Unexpected Serious Adverse Reactions 
 
 
 
4. CLINICAL INVESTIGATION SUMMARY 
 
 
Title 
CT Lucia 601 IOL implantation in the sulcus 
Reference Number 
(Acronym) 
CLuS 
Clinical phase 
Post-marketing study (phase 4) 
Objectives 
To perform a retrospective investigation of the CT Lucia 601 IOL 
implantation in the sulcus 

 
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Endpoints 
Primary endpoint: determine whether the CT Lucia 601 IOL can 
be used safely in the sulcus 
Design 
Non-commercial (academic with study grant), monocentric,  
post-interventional observational without use of a study drug 
 
Data Collection 
A single late-postoperative visit, scheduled ≥ 6 months after the 
vitrectomy  
See Study Flow Chart 7.3 
Planned Clinical 
investigation Period 
2019-2020 
Clinical investigation 
population 
Patients who had an implantation of the CT Lucia 601 lens  
Number of Participants 
100 
Inclusion/Exclusion 
Criteria 
Inclusion criteria 
 
Patients with an implantation of a CT Lucia 601 lens for 
different reasons: 
o 
During vitrectomy to treat a complicated cataract 
surgery and had the implantation of a CT Lucia 601 
IOL in the sulcus or patients  
o 
During phaco surgery with a posterior capsule tear 
that necessitated the implantation of the implant lens 
in the sulcus 
o 
Explantation of an in-the-bag lens and implantation 
of a CT Lucia 601 as replacement lens (e.g. to treat 
opacification of the implant lens or intolerance of the 
implant lens).  
 
Age : > 18 years 
 
Signed informed consent 
 
Preoperative myopia less than 10 diopters 
 
Implantation of the CT Lucia IOL at least six months earlier 
 
Exclusion criteria 
 
History of uveitis 
 
Ocular pathology or history that could influence the biometry 
of the effective lens position, such as ocular trauma with 
zonulolysis, congenital iris- or lens defects etc. 
 
Any eye condition influencing the lens position (to be 
specified) according to the investigator 
 
Device Name 
CT LUCIA hydrophobic C-loop IOL: CT Lucia® 601P 
(hydrophobic acrylic with heparin coated surface) 

 
                   S64878 CLus study_V3_08022021                                               Pagina 10 van 29 
 
Principle Intended Use 
All devices are CE marked and used within their claimed 
intended use. In general, all devices are intended to be used 
during ophthalmic surgery. 
Manufacturer Name 
CT LUCIA 601P 

 
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5. INTRODUCTION 
 
Preface 
 
In Belgium, approximately 120 000 cataract surgeries are performed annually. During this 
surgery, the lens is removed from its bag, and replaced by an intra-ocular lens (IOL). 
Older types of IOLs are made from non-foldable PMMA, requiring to make a large incision 
the eye. Modern types of IOLs are made from foldable acrylic material, allowing the 
insertion of the IOL through an incision as small as 1.8 mm. Preferably, the IOL is inserted 
in the lens bag, but in approximately 1 in 500 surgeries, a break of the posterior lens 
capsule occurs. When this complication occurs, it may not be possible anymore to use an 
in-the-bag implantation. In this case, the IOL can be inserted in front of the anterior lens 
bag (and behind the iris), which is named “in-the-sulcus” implantation. If no lens capsule 
is available, as a last resort the IOL can be clipped on the anterior side of the iris, using a 
dedicated “irisclaw” IOL. Such complicated surgeries are usually referred to the 
vitreoretinal department in third-line care centers. In our center, we treat such referred 
complicated cases weekly. 
Another condition where implantation of an IOL in the sulcus may be required is when the 
implanted IOL (in the bag) opacifies or is not tolerated by the patient (mostly in case of 
multifocal IOL). In such case, the IOL is usually removed from the bag and replaced by an 
IOL in the sulcus. 
 
 
Requirements of sulcus IOLs 
 
For optimal performance and stability, the following properties are preferred for an IOL 
that is inserted in the sulcus: 
 
A relatively large optical part of ≥ 6 mm to avoid entrapment of the pupil behind 
the optic op the IOL 
 
An angulated IOL design that brings the optic of the IOL backward in order to avoid 
contact with the posterior side of the iris and also to avoid entrapment of the pupil 
 
A large IOL total diameter, since the diameter of the sulcus is larger than the lens 
bag 
 
A design of the IOL haptics that created a large contact area between the IOL and 
the sulcus 
 
A preloaded IOL system to avoid contamination of the IOL before and during 
insertion that could lead to postoperative infection (endophthalmitis). The use of a 
preloaded system is nowadays considered as the most effective preventive 
measure to avoid such serious complication. 
 
Availability of sulcus IOLs 
 
A few older PMMA IOL types are available that are on-label certified for use in the sulcus. 
However, since the use of these IOLs requires a large incision in the eye and are not 
preloaded, the use of these lenses is not up to the standard-of-care in modern lens 
surgery.  
In our center, we have been using the IOL “PolyAI” from Physiol, that was certified for use 
in the sulcus. However, when production of this IOL was discontinued a few years ago, we 
had to look for a suitable alternative. At that time, a review of the commercially available 

 
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IOLs was performed, and it was decided that the IOL “CT Lucia 601” from Zeiss had all the 
properties that we considered as important for in-the-sulcus implantation, in spite of the 
lack of an official “in the sulcus” label. Also since we could not find any foldable and 
preloaded IOL that was officially labeled as “sulcus-IOL”, we have implanted this IOL in 
the sulcus in ~150 patients witch complicated cataract surgery. During the surgery, we 
found that this IOL had even better handling properties compared to the PolyAI that 
facilitate the in-the-sulcus positioning. It unfolds very slowly after insertion in the eye, 
allowing the surgeon to accurately place the IOL haptics in the desired position. Also during 
the postoperative visits, we assessed a very good centration and positioning of this CT 
Lucia 601 IOL. 
Unfortunately, the IOL manufacturer (Carl Zeiss) decided last year to change the design 
of the CT Lucia 601, referred to as CT Lucia 611. Although this new design allows easier 
implantation in the bag, it makes the IOL in our evaluation less suitable for in-the-sulcus 
implantation. This concern was reported to and discussed with Zeiss. We have suggested 
to perform a post-implantation analysis study to objectively evaluation the use of the CT 
Lucia 601 IOL as a sulcus lens. Zeiss has agreed to continue the delivery of the CT Lucia 
601 for this purpose.  
 
 
Study expenses 
 
Besides the examinations collected during the long-term postoperative visit, no additional 
study examinations are required outside of the normal standard-of-care. 
The CT Lucia 601 IOL is registered by the FAGG and reimbursed by the RIZIV/INAMI in 
the same way as any other IOL, and is already registered in our hospital (CMM), hence 
there are no additional expenses involved for the patients or for the RIZIV/INAMI that 
have this IOL implanted. Also, inclusion in the study will be done post-interventionally, 
hence the vitrectomy surgery itself is not part of the study. 
 
 
6. OBJECTIVES 
 
The purpose of the study is to collect data that are parameters of post-IOL implantation 
safety: 
 
Questionnaire on subjective quality of vision 
 
Centration and anteroposterior position of the IOL (using biometry) 
 
Presence and quantification of any inflammation or pigment present in the anterior 
chamber (flare meter) 
 
Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 
IOL in-the-sulcus and quantification of higher-order aberrations (HOA) 
 
General safety-parameters: 
o 
Visual acuity  
o 
Intra-ocular pressure 
o 
Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-
OCT) 
o 
Any adverse ophthalmic events  
 
 

 
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7. CLINICAL INVESTIGATION DESIGN 
 
Inclusion of the patients will be done post-interventionally: patients that underwent a 
(usually urgent) vitrectomy to treat a complicated cataract surgery with the implantation 
of a CT Lucia 601 IOL in the sulcus will be asked to participate in this clinical trial.  
For this trial, one additional long-term postoperative visit (at least 6 months after the 
vitrectomy) will be required besides the standard-of-care visits. During this study visit, 
besides the standard ophthalmological clinical examination and a questionnaire about 
subjective vision quality, the following technical examinations will be performed: 
 
1. Biometry (using Zeiss IOLmaster 700 SS-OCT and Oculus Pentacam) to assess the 
position of the IOL in relation to the cornea (centration and anterior chamber 
depth). 
2. SD-OCT to assess the potential presence of macular edema or retinal nerve fiber 
layer (RNFL) thinning. 
3. Anterior chamber flare to determine the amount of inflammation and pigment 
dispersion present in the anterior chamber (using Kowa Flare Meter). 
4. Quantification of HOA using iDesign Hartmann shack aberrometer 
 

 
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8. CLINICAL INVESTIGATION POPULATION 
 
8.1. 
Number of participants 
A total of 100 patients will be included. 
Estimated enrolment time is 12months  
8.2. 
Inclusion criteria 
 
Patients who had implantation of a CT Lucia 601 lens for different reasons: 
 
 
During vitrectomy to treat a complicated cataract surgery and had the implantation 
of a CT Lucia 601 IOL in the sulcus or patients 
 
During phaco surgery with a posterior capsule tear that necessitated the implantation 
of the implant lens in the sulcus 
 
Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement 
lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens). 
 
Age : > 18 years 
 
Signed informed consent 
 
Preoperative myopia less than 10 diopters 
 
Implantation of the CT Lucia IOL at least six months earlier 
 
 
 
8.3. 
Exclusion criteria 
 
 
History of uveitis 
 
Ocular pathology or history that could influence the biometry of the effective lens 
position,  
such as ocular trauma with zonulolysis, congenital iris- or lens defects etc. 
 
Any eye condition influencing the lens position (to be specified) according to the 
investigator 
 
 
9. PARTICIPANT SELECTION AND ENROLMENT 
 
9.1. 
Identifying participants 
The particiants of the study are patients who had an implantation of a CT Lucia 601 lens 
at least six months earlier. This could be for different reasons such as a complicated 
cataract surgery, a posterior capsule tear during vitrectomy or an explantation of an in-
the-bag lens with placement of a sulcuslens. 
 
The patients will be contacted by the study nurse to inform them about the study and its 
purpose. An information brochure and a copy of the informed consent will be sent to the 
patient after this informative call to allow to read the information through at home. About 
1-2 weeks later, after receiving the informed consent form, the patients will receive a 
second call to ask for final approval or disapproval to be enrolled in the trial and to make 
one visit in het hospital for some postoperative non-invasive examinations. 
 

 
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9.2. 
Consenting participants 
 
Patients that had an implantation of the CT Lucia 601 at least 6 months ago, will receive 
a phone call of the study nurse and will receive an informed consent at home. After 2 
weeks the study nurse will make a second call to ask the patients to participate in the 
clinical trial. Per patient, both eyes will be eligible for inclusion in the study. The 
contralateral eye without CT Lucia 601 will be used to create a control group.  
Following the guidelines of the Ethics Review Committee of the World Health Organisation 
(WHO ERC), potential participant must personally sign and date the latest approved 
version of the informed consent form before any clinical investigations are performed. 
 
Written and verbal versions of the participant information and Informed consent will be 
presented to the participants detailing no less than: the exact nature of the clinical 
investigation; the implications and constraints of the clinical investigation plan; the known 
side effects and any risks involved in taking part. It will be clearly stated that the 
participant is free to withdraw from the clinical investigation at any time for any reason 
without prejudice to future care, and with no obligation to give the reason for withdrawal. 
 
The participant will be allowed as much time as wished to consider the information, and 
the opportunity to question the Investigator, their GP or other independent parties to 
decide whether they will participate in the clinical investigation. Written Informed Consent 
will then be obtained by means of participant dated signature and dated signature of the 
person who presented and obtained the informed consent. The person who obtained the 
consent must be suitably qualified and experienced, and have been authorised to do so 
by the Coordinating/Principal Investigator. A copy of the signed Informed Consent will be 
given to the participants. The original signed form will be retained at the clinical 
investigation site. 
 
In case of updates of the participant information and Informed consent the participant 
must personally sign and date the latest approved version of the informed consent form 
before any further clinical investigation specific procedures are performed. 
 
For this clinical trial, signature for approval from the patient will be obtained at the 
appointment in the hospital on the date agreed with the study nurse.  
 
9.3. 
Randomisation 
All patients who received a CT Lucia 601 at least 6 months ago will be contacted and 
asked for participation in our clinical trial. There will be no randomization necessary since 
we only plan one postoperative non-invasive visit without performing an invasive 
intervention or using a study drug. All patients will undergo the same technical 
examinations.  
 
 
9.4. 
Withdrawal of participants 
Subjects are free to discontinue participation in the investigation at any time, and without 
prejudice to further treatment. Subjects who discontinue the investigation should always 
be asked about the reason(s) for their discontinuation and about the 

 
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presence of any Adverse Event/Adverse Device Effect or Device Deficiency and, if possible, 
be assessed by an investigator. Adverse Event/Adverse Device Effect should be followed 
up. 
 
Subjects may be withdrawn from investigation treatment and assessments at any time, at 
the discretion of the investigator. 
 
Incorrectly enrolled subjects will be withdrawn from further investigation treatment and 
assessments. A subject may, however, continue the investigation under special 
circumstances (i.e. if continuation of investigation treatment or follow-up actions are 
necessary for the subject’s safety and well-being, or if only a follow-up period remains, 
and the continuation of the investigation is not expected to be associated with any risk or 
discomfort for the subject). 
 
10 
INVESTIGATIONAL DEVICE 
 
10.1. Investigational device details 
 
CT LUCIA hydrophopic C-loop IOL: CT Lucia® 601P 
- 
Hydrophopic acrylic 
- 
Heparin coated surface 
- 
Preloaded system (avoiding contamination and minimizing risk of endophthalmitis) 
- 
Off-label used for ‘in the sulcus’ implantation  
 
 
 
 
 
 
 
 
 
 
 
 
Easy handling properties:  
- 
unfolds very slowly after insertion in the eye: time for positioning IOL haptics  
 
Perfect ‘in the sulcus’ design: good centration and positioning postoperative 
- 
large optical part of ≥ 6 mm to avoid entrapment of the pupil behind the optic  
- 
angulated IOL design that brings the optic backward to avoid contact with iris or 
entrapment of pupil 
- 
IOL haptics make large contact between IOL and the sulcus 
 
10.2. Device manufacturer 
Carl Zeiss NV (Department in Belgium: Ikaroslaan 49 1930 Zaventem, Belgium) 
10.3. Device accountability 
In the hospital, there is a standard procedure for returning faulty products. This procedure 
will be followed, similar to the standard clinical path. 
10.4. Storage conditions 
 

 
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All intra-ocular implant lenses are prepackaged in a sterile way. The CT Lucia 601 comes 
with a disposable preloaded system and are used before expiration date.  
10.5. Concomitant Treatments 
Not applicable  
 
11 
CLINICAL INVESTIGATION ASSESSMENTS 
 
11.1. Investigation Characteristics 
 The following post-operative parameters will be collected: 
 
 
Indication of the surgery with implantation of the lens in the sulcus 
 
Refraction: objective and subjective 
 
Best Corrected Visual Acuity (BCVA) 
 
Pneumotonometry: intra-ocular pressure  
 
Biometry (using Zeiss IOLmaster 700 SS-OCT) to assess the position of the IOL in 
relation to the cornea (anterior chamber depth). 
 
Oculus Pentacam to determine IOL positioning relative to the iris 
 
SD-OCT: to assess the potential presence of macular edema and RNFL thinning 
 
Anterior chamber flare meter (Kowa) to determine the presence and quantification 
of any inflammation or pigment dispersion present in the anterior chamber 
 
Aberrometry to quantify HOA caused by IOL tilting/decentration 
 
Note that all of the above investigation are non-contact measurements, hence 
without any risk of adverse events.  
 
 Questionnaire about subjective quality of vision at least 6 months postop  
 
 
The patient will be asked to grade the quality of vision, at the time of completion, 
with a score of one to five according to the score system below: 
 
 
The questionnaire will be completed during the study visit 
 
 
11.2. Surgical procedure 
 
This is a post-interventional observational study without use of a study drug.   
There will be no surgical procedure in this study since there is only one single  
late-postoperative observational visit with technical examinations.

 
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11.3. Safety assessments 
The reporting rules under the RD of 15/Jul/1997 and 18/Mar/1999 are not applicable in 
this post-marketing study. 
Medical device incidents will be routinely collected and reported under the national 
materiovigilance rules at the discretion of the Investigator. 
11.4. Adverse events that do not require reporting 
 
Not applicable in this study 
 
12. 
DATA QUALITY ASSURANCE 
 
12.1. Monitoring, Audit and Inspections 
Investigator and the institution(s) will permit trial-related monitoring, audits, EC review, 
and regulatory inspections (where appropriate) by providing direct access to source data 
and other documents. 
12.2. Training of staff 
The Principal Investigator will ensure that appropriate training relevant to the investigation 
is given to the medical, nursing and other staff at the site involved and that new 
information of relevance to the performance of this investigation is forwarded to the staff 
involved. 
 
The staff at the investigational site will sign a confirmation document that they are trained. 
12.3. Data Management 
In this study, an electronic case report form (eCRF) will be used for data capture.  As eCRF, 
the RedCap platform will be used, which is supported by the UZleuven. A new project with 
dedicated forms will be created. All changes in the eCRF are logged and time-stamped. 
 
All documents will be stored safely in confidential conditions. On all clinical investigation- 
specific documents, other than the signed consent, the participant will be referred to by 
the clinical investigation participant number/code, not by name or EMR number. 
 
All clinical investigation documentation will be kept for 10 years from the clinical 
investigation plan defined end of clinical investigation point. When the minimum 

 
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retention period has elapsed, clinical investigation documentation will not be destroyed 
without permission from the sponsor. 
 
13. 
STATISTICS 
 
 
13.1. Description of statistical methods 
 
The results from this clinical investigation will be presented with descriptive 
statistics. No hypothesis testing is planned for this investigation. 
 
For continuous variables (ex: age) 
In case, the data follow of a normal distribution the T-Test will be applied and the data 
will be reported as the means and standard deviations by group. Otherwise a signed- rank 
test of Wilcoxon will be performed and the data will be report as the medians and 
interquartile ranges. 
 
For count data, the Pearson’s Chi² test will be applied to compare the groups and the data 
will be reported by counts and proportions by group. 
13.2. The number of participants 
Given the exploratory nature of the trial, 100 patients will be recruited by group. 
 
13.3. The level of statistical significance 
For all analyses, the level of significance will be 5% two-sided significant level. 
 
13.4. Criteria for the termination of the clinical investigation 
There will be only one postoperative visit to examine the patients, the clinical investigation 
will be terminated after this visit. No statistical interim analysis is planned.  
 
13.5. Procedure for accounting for missing, unused and spurious data 
Missing data will be reported with reasons given where available, and the missing data 
pattern will be examined. We will explore the mechanism of missing data by means of 
logistic regression models which will explore if missingness (i.e. whether the primary 
outcome is missing or not) is related to measured baseline variables. Covariates found to 
be predictive of missingness will, where appropriate, be included as a covariate in the 
analysis model. 
13.6. Procedures for reporting any deviations from the original 
statistical plan 
The final statistical plan will be agreed prior to final data lock and prior to any analyses 
taking place. Any deviation thereafter will be reported in the final trial report. 
 
13.7. Inclusion in analysis 
All patients who received a CT Lucia 601P IOL will be contacted and asked to participate 
in the trial.  
 
 
 
 
 

 
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14. 
Clinical Investigation Management 
 
14.1. Clinical investigation management group and parties involved 
 
The clinical investigation management group consists of the following 
participants: 

 
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Principal Investigator 
Name: Peter Stalmans 
Title: Vitreoretinal surgeon 
Address: 
UZLeuven 
Herestraat 49 
3000 Leuven 
Telephone: 
Email: oogziekten@uzleuven.be 
Statistician 
Name: Mr. Jean-François Fils 
Title: Bio-Statistician 
Address:Ars Statistica, Nivelles 
Telephone: 
Email: 
Clinical investigation Management 
Name: Ingeborg Vriens 
Title: Study Nurse 
Address: 
UZLeuven 
Herestraat 49 
3000 Leuven 
Telephone: +32 16 34 22 29 
Email: Ingeborg.vriens@uzleuven.be 
 
 
 
Clinical investigation Coordination Centre 
 
For general queries, supply of clinical investigation documentation, and collection of 
data, please contact the Clinical Investigation Coordinator: 
 
Name: Ingeborg Vriens 
Address: Herestraat 49, 3000 Leuven 
Telephone: +32 16 34 22 29 
Email: ingeborg.vriens@uzleuven.be 
 
Clinical Queries 
 
Clinical queries should be directed to oogziekten@uzleuven.be who will direct the query 
to the appropriate person 

 
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Investigation site 
 
Name: UZ Leuven 
Address: Herestraat 49, 3000 Leuven 
Telephone: +32 16 33 26 60 
Email: oogziekten@uzleuven.be 
 
 
 
Sponsor 
 
Name: UZ Leuven 
Address: Herestraat 49, 3000 Leuven 
Telephone: +32 16 33 23 70 
Email: oogziekten@uzleuven.be 
 
 
Funder (application was sent in) 
 
Name: Carl Zeiss NV, Department in Belgium 
Address:  Ikaroslaan 49, 1930 Zaventem 
Telephone: +32 2 719 39 11 
Email: info@zeiss.be 
 
 
 
 
 
 
14.2. Clinical investigation steering committee 
Patients included in this clinical trial follow the standard clinical path, underwent prior 
surgery using the standard vitrectomy device and using the currently used instruments. 
During the (single) study visit, all tests are non-contact examinations and performed by 
an experienced study nurse. Hence, there is no increased safety risk for patients enrolled 
in this investigation. For this this reason, no steering committee or DMC will be constituted. 
14.3. 
Data monitoring committee 
 
N/A, see section 14.2. 
 
 
14.4. 
Monitoring plan 
 
The study protocol will be reviewed by the CTC prior to study approval. If the CTC evaluates 
that the study should be monitored, a monitor will be appointed by the CTC. In this case, 
the monitor will visit the Investigator site prior to the start of the clinical investigation and 
during the course of the clinical investigation if required, in accordance with the monitoring 
plan. Monitoring will be performed according to ISO 14155:2011. 
Data will be evaluated for compliance with the clinical investigation plan and accuracy in 
relation to source documents. Following written standard operating procedures, the 
monitors will verify that the clinical investigation is conducted and data are generated, 
documented and reported in compliance with the clinical investigation plan, GCP and the 
applicable regulatory requirements. 

 
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15. 
GOOD CLINICAL PRACTICE 
 
15.1. Declaration of Helsinki 
The Investigator will ensure that this clinical investigation is conducted in full conformity 
with the current revision of the Declaration of Helsinki (last amended October 2000, with 
additional footnotes added 2002 and 2004). 
15.2. Guidelines for GCP 
The Investigator will ensure that this clinical investigation is conducted in full conformity 
with relevant regulations and with the International standard for Good Clinical Practice for 
clinical investigations of medical devices for human subjects (ISO 14155:2011). 
15.3. Ethics review 
The clinical investigation plan, Investigator’s Brochure, Case Report Forms (CRFs), 
informed consent form, participant information sheet and any other documents needed for 
review by an appropriate Ethics Committee (EC) or regulatory authority will be submitted 
to obtain written approval. Any additional requirements imposed by the EC or regulatory 
authority will be followed, if appropriate. 
 
The Investigator will submit and, where necessary, obtain approval for all amendments to 
the original approved documents. Furthermore, the clinical investigation will not begin until 
the required approval/favourable opinion of the EC or regulatory authority has been 
obtained. 
15.4. Patient Information and Consent Form 
The Principal Investigator will ensure that the subject is given full and adequate oral and 
written information about the nature, purpose, possible risks and benefits of the 
investigation. Subjects must also be notified that they are free to discontinue participation 
in the investigation at any time. The subject should be given the opportunity to ask 
questions and time for consideration. 
 
The subject’s signed informed consent has to be obtained before conducting any 
investigation related procedures. The original must be filed by the Principal Investigator. 
A copy of the Patient Information including the signed Consent Form should be given to 
the subject. If modifications are made according to local requirements, the new version 
must be approved by the EC. 
15.5. Subject data protection 
The clinical investigation staff shall treat all information and data relating to the Study 
disclosed to Participating Site and/or Investigator in this Study as confidential and shall 
not disclose such information to any third parties or use such information for any purpose 
other than the performance of the Study. The collection, processing and disclosure of 
personal data, such as patient health and medical information is subject to compliance 
with applicable personal data protection and the processing of personal data (Regulation 
(EU) 2016/679 also referred as the General Data Protection Regulation ("GDPR") and the 
Belgian Law of July 30 2018 on the protection of natural persons with regard to the 
processing of personal data) 
 
The clinical investigation staff will ensure that the participants’ anonymity is maintained. 
The participants will be identified only by initials and a participants ID number on the CRF 
and any electronic database. All documents will be stored securely and only accessible by 
clinical investigation staff and authorised personnel. The clinical investigation will comply 

 
                   S64878 CLus study_V3_08022021                                               Pagina 24 van 29 
 
with the Data Protection Act which requires data to be anonymised as soon as it is practical 
to do so. 
 
15.6. Procedures in case of medical emergency 
The Principal Investigator is responsible for ensuring that procedures and expertise are 
available to cope with medical emergencies during the investigation. 

 
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16. 
CLINICAL INVESTIGATION CONDUCT RESPONSIBILITITES 
 
16.1. Clinical investigation plan amendments 
Amendments to the clinical investigation plan must be submitted to the Sponsor for review 
before submitting to the appropriate EC and Regulatory Authority for approval. 
 
16.2. Clinical investigation plan violations, deviations and serious 
breaches 
The Clinical investigator will not implement any deviation from the clinical investigation 
plan without agreement from the Sponsor, except where necessary to eliminate an 
immediate hazard to clinical investigation participants. 
In the event that the Clinical investigator needs to deviate from the clinical investigation 
plan, the nature of and reasons for the deviation will be recorded in the CRF and notified 
to the Sponsor. If this necessitates a subsequent clinical investigation plan amendment, 
this will be submitted to the Sponsor for approval and then to the appropriate REC and 
Regulatory Authority for review and approvals as appropriate. It is Sponsor policy that 
waivers to the clinical investigation plan will not be approved. 
In the event that a serious breach of GCP is suspected, this will be reported to the Sponsor 
immediately. 
16.3. End of clinical investigation 
The end of clinical investigation is defined as the last participant’s last visit. 
The investigator and/or the clinical investigation steering committee have the right at any 
time to terminate the clinical investigation for clinical or administrative reasons. 
 
The end of the clinical investigation will be reported to the EC and Regulatory Authority 
within 90 days, or 15 days if the clinical investigation is terminated prematurely. The 
Investigators will inform participants of the premature clinical investigation closure and 
ensure that the appropriate follow up is arranged for all participants involved. 
A summary report of the clinical investigation will be provided to the EC and Regulatory 
Authority within 1 year of the end of the clinical investigation. 
16.4. Insurance and indemnity 
In accordance with the Belgian Law relating to experiments on human persons dated May 
7, 2004, Sponsor shall assume, even without fault, the responsibility of any damages 
incurred by a Study Patient and linked directly or indirectly to the participation to the 
Study, and shall provide compensation therefore through its insurance.” 
16.5. Funding 
A grant request to support this retrospective clinical trial will be sent to Carl Zeiss.  
 
17. 
REPORTING, PUBLICATIONS AND NOTIFICATIONS OF RESULTS 
 
17.1. Authorship policy 
Ownership of the data arising from this clinical investigation resides with the clinical 
investigation team.  On completion of the clinical investigation, the clinical investigation 

 
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data will be analysed and tabulated, and a clinical investigation report will be prepared in 
accordance with ISO14155:2011. 
17.2. Publication 
The Principal Investigator will decide to publish the obtained study data. The statistician 
will provide a study report, which will be used as source data to write the results section 
of the manuscript. The publication will also cover authorship, acknowledgements 
(mentioning the grant provider of the trial), and an overview of relevant scientific 
publications. 
Before submitting for publication, the manuscript will be sent to the grant provider, 
allowing the grant provider give feedback on the manuscript within 2 weeks. It is up to the 
Principal Investigator to decide to make any changes to the manuscript based on this 
feedback. 
 
 
18. 
REFERENCES  
 
1. Intraocular Lens Implantation in The Ciliary Sulcus: Challenges And Risks. Mehta 
R, Aref AA. Clin Ophthalmol. 2019 Nov 27;13:2317-2323. 
2. Observational study of intraocular lens tilt in sutureless intrascleral fixation versus 
standard transscleral suture fixation determined by ultrasound biomicroscopy. 
Marianelli BF, Mendes TS, de Almeida Manzano RP, Garcia PN, Teixeira IC. Int J 
Retina Vitreous. 2019 Jul 29;5:33. 
3. Uveitis-Glaucoma-Hyphaema Syndrome. General review. Zemba M, Camburu G. 
Rom J Ophthalmol. 2017 Jan-Mar;61(1):11-17. 
4. Stability and safety of MA50 intraocular lens placed in the sulcus. Kemp PS, Oetting 
TA. Eye (Lond). 2015 Nov;29(11):1438-41. 
 
 
 

 
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19. 
SAFETY REPORTING 
 
19.1. Definitions 
 
Device Deficiency (DD) 
 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. 
 
Note: 
 
Device Deficiencies include malfunctions, use errors, and inadequate labelling. 
 
All Device Deficiencies that might have led to a Serious Adverse Device Effect shall be 
reported in accordance with Serious Adverse Event reporting procedures, as specified 
below. 
 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational device. 
 
Note: 
 
This definition includes events related to the investigational device or the 
comparator. 
 
This definition includes events related to the procedures involved. 
 
For users or other persons, this definition is restricted to events related to 
investigational devices. 
 
Adverse Device Effect (ADE) 
Adverse Event related to the use of an investigational device. 
 
Note: 
 
This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, or operation, or any malfunction 
of the investigational device. 
 
This definition includes any event resulting from use error or from intentional 
misuse of the investigational device. 
 
Serious Adverse Event (SAE) 
Adverse Event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, that resulted in any of the following: 
1) a life-threatening illness or injury, 
2) permanent impairment of a body structure or a body function, 
3) hospitalization or prolongation of patient hospitalization, 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
5) chronic disease 
c) foetal distress, foetal death or a congenital physical or mental impairment or birth 
defect. 

 
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Note: 
Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
Serious Adverse Device Effect (SADE) 
Adverse Device Effect that has resulted in any of the consequences characteristic of a 
Serious Adverse Event. 
19.2. Procedures for reporting SAE /SADE or DD that could have led to a 
SADE 
 
All SAEs/SADEs that occurs during the Clinical Investigation shall be reported, whether 
or not they are considered causally related to the investigational device. 
 
Device Deficiencies that might have led to SADE must be reported as a SADE if either 
a) suitable action had not been taken, 
b) if intervention had not been made, or 
c) if circumstances had been less fortunate 
 
The investigator is responsible for informing the EC/IRB and/or the Competent Authority 
of the SAE/SADE as per local requirements. For this reason, medical device incidents will 
be routinely collected and reported under the national materiovigilance rules at the 
discretion of the Investigator. 
19.3. Procedures for Device Deficiency reporting 
 
Device Deficiencies will be routinely collected and reported to the corresponding 
manufacturer(s) as soon as possible, without unjustified delay (i.e. on the same working 
day). If the Device Deficiency might have led to a SADE the reporting requirements for 
SADE described above must be followed. 
19.4. Causality Assessment 
The relationship between the use of the investigational device and the occurrence of 
each AE/SAE shall be assessed by the investigator and the manufacturer and classified 
as investigational device related or not related to investigational device. 
19.5. Recording of safety information 
All safety issues occurring during the clinical investigation observed by the investigator 
or reported by the participant, whether or not attributed to the device under 
investigation will be recorded on the CRF as specified in the clinical investigation plan. 
 
The following information will be recorded: description, date of onset and end date, 
severity, assessment of relatedness to device, other suspect drug or device and action 
taken.  Follow-up information should be provided as necessary. 
 
The relationship to the device will be assessed by a medically qualified investigator or 
the sponsor and will be followed up until resolution or the event is considered stable. 

 
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All ADE that result in a participant’s withdrawal from the clinical investigation or are 
present at the end of the clinical investigation, should be followed up until a satisfactory 
resolution occurs. 
 
Where relevant, any pregnancy occurring during the clinical investigation and the outcome 
of the pregnancy should be recorded and followed up for congenital abnormality or birth 
defect. 
19.6. Reporting procedure for all SAEs/SADEs 
Reporting to the local national competent authority and the manufacturer will be done by 
the Principal Investigator. 
 
 
The principal investigator has a legal obligation to report all events that need to be 
reported to the Nominated Competent Authority immediately (without any 
unjustifiable delay) after a link is established between the event and the device, but 
no more than:2 days following the awareness of the event for Serious Public Health 
Threat. 
 
10 days following awareness of the event for Death or unanticipated serious 
deterioration in health. 
 
30 days following the awareness of the event for all other event meeting the SAE 
criteria. 
 
Device Deficiencies, including SAEs/SADEs will 
be 
reported 
to 
the 
corresponding 
manufacturer(s) as soon as possible, without unjustified delay (i.e. on the same working 
day). 
19.7. Annual reports 
In addition to the expedited reporting above, the Principal Investigator shall submit once 
a year throughout the clinical investigation or on request a Safety Report to the 
Competent Authority and Ethics Committee