Zeiss RESIGHT Disposable Lenses Evaluation Study: Investigator-initiated, Mono-center, Academic, Prospective, Interventional Case Study
Phase: NA
Conditions: Retinal Detachment, Macular Pucker, Macular Holes, Vitreomacular Traction
Sponsor: Universitaire Ziekenhuizen KU Leuven

UZ Leuven – KU Leuven 
 
 
Protocol: RESIGHT Disposable 
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CLINICAL INVESTIGATION PLAN (CIP) 
 
Title: ZEISS RESIGHT Disposable Lenses evaluation study 
 
RESIGHT Disposable 
 
Version number: v 1.0  –  Date 7/03/2023 
 
Clinical Investigation number: S67415 
 
Single Identification Number (SIN): CIV-23-02-042213 
 
Sponsor 
<University Hospitals Leuven (UZ Leuven) or KU Leuven> 
Herestraat 49, B-3000 Leuven 
 
Coordinating Investigator 
Peter Stalmans 
 
 
 
 
Confidentiality Statement 
The information in this document is strictly confidential and is available for review to Investigators, potential 
Investigators and appropriate Ethics Committees, Institutional Review Boards or Competent Authorities. No 
disclosure should take place without written authorization from the Sponsor. 
 
 

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LIST OF PARTICIPATING SITES 
(if applicable) 
List Of Participating Sites 
Principal Investigator 
Not applicable (single site UZ Leuven) 
 
 
 
 
 
 
 

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SIGNATURES 
 
Title: ZEISS RESIGHT Disposable Lenses evaluation study 
CIP: RESIGHT Disposable 
 
The undersigned confirm that the following CIP has been acknowledged and accepted and that they 
agree to conduct the Investigation in compliance with the approved CIP (and any subsequent 
amendments if applicable) and will adhere to the principles outlined in the Declaration of Helsinki, 
applicable Good Clinical Practices and regulations (e.g., the EU Medical Device Regulation 2017/745 
(MDR), EU General Data Protection Regulation 2016/679 (GDPR)) and ISO 14155:2020), the 
appropriate local legislation(s) and all other applicable legal and regulatory requirements as amended. 
The most stringent requirements, guidelines or regulations must always be followed. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the Investigation without the prior written 
consent of the Sponsor. 
I also confirm that I will make the findings of the Investigation publicly available through publication or 
other dissemination tools, in accordance with this CIP without any unnecessary delay and that an 
honest accurate and transparent account of the Investigation will be given; and that any discrepancies 
from the Investigation as planned in this CIP will be explained. 
 
Coordinating Investigator 
 
 
Prof. Dr. Peter Stalmans 
………………………… 
………………………… 
 
Name & Title 
Signature 
Date 
 
Principal Investigator (Participating Site) (Principal Investigator is the same as Coordinating 
Investigator in case of a monocentric investigation) 
 
 
Prof. Dr. Peter Stalmans 
………………………… 
………………………… 
 
Name & Title 
Signature 
Date 
 
 
 

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TABLE OF CONTENTS 
 
1.1 
Surgical microscope device .......................................................................................................................... 13 
1.1.1 
Double binocular optical tract. ............................................................................................................... 13 
1.1.2 
Red reflex..................................................................................................................................................... 13 
1.1.3 
Wide-angle retina viewing system ......................................................................................................... 13 
1.1.4 
3D Viewing .................................................................................................................................................. 18 
1.1.5 
Image layover .............................................................................................................................................. 19 
1.1.6 
iOCT ............................................................................................................................................................. 19 
1.2 
Disposable RESIGHT Lenses ....................................................................................................................... 20 
2.1 
Study objectives and hypotheses ................................................................................................................ 21 
2.2 
Primary Endpoints .......................................................................................................................................... 22 
2.3 
Design of the Clinical Investigation ............................................................................................................ 23 
2.4 
Justification for the design of the Investigation ....................................................................................... 23 
2.5 
Expected Duration of the Investigation .................................................................................................... 23 
3.1 
Inclusion criteria.............................................................................................................................................. 24 
3.2 
Exclusion criteria ............................................................................................................................................ 24 
4.1 
Participant consent and withdrawal of consent ...................................................................................... 24 
4.2 
Selection of Participants / Recruitment ..................................................................................................... 24 
4.3 
Randomization Procedure (if applicable) .................................................................................................. 25 
4.4 
Premature discontinuation ........................................................................................................................... 25 
5.1 
Intended use ..................................................................................................................................................... 26 
5.2 
Identification and description of the IMD ................................................................................................. 26 
5.3 
Instructions for use ........................................................................................................................................ 26 
5.4 
Device qualification and classification ........................................................................................................ 26 
5.5 
Device Accountability .................................................................................................................................... 26 
6.1 
Definitions ........................................................................................................................................................ 27 
6.1.1. 
Adverse Event (AE) ................................................................................................................................... 27 
6.1.2. 
Serious Adverse Event (SAE) .................................................................................................................. 27 
6.1.3. 
Adverse Device Effect (ADE) ................................................................................................................. 27 
6.1.4. 
Serious Adverse Device Effect (SADE) ................................................................................................ 27 
6.1.5. 
Device Deficiency (DD) ........................................................................................................................... 28 
6.2 
Adverse Events that do not require reporting ........................................................................................ 28 
6.3 
Recording and reporting of Adverse Events ............................................................................................ 28 
6.3.1 
Assessment .................................................................................................................................................. 29 
6.3.2 
Timelines for reporting ............................................................................................................................ 30 
6.3.3 
Follow-up ..................................................................................................................................................... 30 

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6.3.4 
Pregnancy ..................................................................................................................................................... 31 
6.3.5 
Death ............................................................................................................................................................ 31 
6.4 
Recording and reporting of Device Deficiencies .................................................................................... 31 
6.5 
Reporting requirements to Ethics Committee’s (EC’s) and Competent Authorities (CA’s) ...... 31 
6.5.1 
Sponsor’s reporting of Serious Adverse Events and Device Deficiencies ................................... 31 
6.5.2 
Annual reporting ........................................................................................................................................ 32 
6.5.3 
Overview reporting requirements ........................................................................................................ 32 
6.6 
Data Safety Monitoring Board (DSMB) ..................................................................................................... 32 
7.1 
Sample Size Determination .......................................................................................................................... 33 
7.2 
Statistical Analysis ........................................................................................................................................... 33 
7.2.1 
Efficacy Analysis .......................................................................................................................................... 33 
7.2.2 
The level of statistical significance ......................................................................................................... 33 
7.2.3 
Procedure for accounting for missing, unused and spurious data ................................................. 33 
7.2.4 
Procedures for reporting any deviations from the original statistical plan .................................. 33 
7.2.5 
Inclusion in analysis .................................................................................................................................... 34 
7.3 
Interim Analysis and Final Database Lock ................................................................................................ 34 
8.1 
Data Collection Tools and Source Document Identification .............................................................. 34 
8.1.1 
Operational aspects................................................................................................................................... 34 
8.1.2 
Legal requirements .................................................................................................................................... 35 
8.2 
Audits and Inspections................................................................................................................................... 35 
8.3 
Monitoring ........................................................................................................................................................ 36 
8.4 
Archiving ........................................................................................................................................................... 36 
9.1 
Ethics Committee (EC) review & reports ................................................................................................ 37 
9.2 
Peer review ...................................................................................................................................................... 37 
9.3 
Regulatory Compliance ................................................................................................................................. 37 
9.4 
CIP / GCP compliance ................................................................................................................................... 37 
9.5 
Data protection and participant confidentiality ...................................................................................... 38 
9.6 
Insurance ........................................................................................................................................................... 38 
9.7 
Amendments .................................................................................................................................................... 38 
9.8 
Post-Study activities ....................................................................................................................................... 39 
10.1 
Authorship policy ........................................................................................................................................... 39 
10.2 
Publication ........................................................................................................................................................ 39 
 
 
 

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LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
(e)CRF 
(electronic) Case Report Form 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
APR 
Annual Progress Report 
AR 
Adverse Reaction 
ASADE 
Anticipated Serious Adverse Device Effect 
BCVA 
Best-corrected visual acuity 
CA 
Competent Authority 
CI 
Coordinating Investigator 
CIP 
Clinical Investigation Plan 
CM 
Concomitant Medication 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
DD 
Device Deficiency 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EMR 
Electronical Medical Record 
FAMHP  
Federal Agency for Medicines and Health Products 
FPFV 
First Patient First Visit 
GCP 
Good Clinical Practice (latest version of ICH E6) 
GP 
General Practitioner 
IB  
Investigator Brochure  
ICF 
Informed Consent Form 
IMD 
Investigational Medicinal Device 
ISF 
Investigator Site File 
KWS 
Klinisch workstation, i.e. the EMR used in the UZ Leuven 
Log MAR 
Logarithm of the minimal angle of resolution 
LPLV 
Last Patient Last Visit 
PI 
Principal Investigator (Participating Site) 
PRO 
Patient Reported Outcome 
SADE 
Serious Adverse Device Effect 

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SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
TMF 
Trial Master File 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

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FUNDING AND SUPPORT 
Funder 
Type of Financial or Non-Financial Support 
Carl Zeiss Meditec AG 
Grant 
 
 
 
 

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ROLES AND RESPONSIBILITIES 
The Principle Investigator (PI) is responsible for the conduct of the Investigation at his/her Participating 
Site, and for protecting the rights, safety and well-being of the participants. As such the PI must ensure 
adequate supervision of the Investigation conduct at the Participating Site. If any tasks are delegated, the PI 
will maintain a log of appropriately qualified persons to whom he/she has delegated specified Investigation-
related duties. The PI will ensure that adequate training is provided and documented for all Investigation 
staff, prior to conducting assigned Investigation-related activities.  
It is the Coordinating Investigator’s (CI’s) responsibility to supervise the general conduct (e.g., study 
progress, communication, CIP training and support of the participating sites, annual reporting, end of 
Investigation notification(s) and results reporting etc.) of the Investigation. The CI fulfils both Investigator’s 
and Sponsor’s responsibilities, as outlined in ISO 14155:2020 and applicable regulations. 
PI and CI shall each be referred to as «Investigator(s)». 
 
 

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CIP SYNOPSIS 
 
Title of clinical Investigation 
(«Investigation») 
Title: ZEISS RESIGHT Disposable Lenses evaluation study 
CIP Short Title 
Acronym 
RESIGHT Disposable 
Sponsor name 
<University Hospitals Leuven (UZ Leuven) or KU Leuven> 
Coordinating Investigator 
Peter Stalmans 
           Contact Address CI 
UZ Leuven, Herestraat 49, 3000 Leuven 
           Contact Email CI 
peter.stalmans@uzleuven.be 
           Contact Phone CI 
+32 16 34 22 29 
SIN number 
CIV-23-02-042213 
Other 
public 
database 
number  
not applicable  
Principal Investigators and 
Participating Sites 
not applicable 
Medical condition or disease 
under investigation 
-Macular pathology requiring surgery: macular pucker, macular hole, 
vitreomacular traction 
-Retinal detachment 
Study rationale  
See row below 
Primary objective 
To evaluate the intra-operative efficacy of a new intra-operative viewing 
device. 
Secondary objective(s) 
/ 
Clinical Investigation Design 
Investigator-initiated, mono-center, academic, prospective, interventional 
case study 
Endpoints 
To determine the effectiveness of the device compared to the reusable 
RESIGHT lenses and Vitreq contact lens presently used as standard-of-care. 
Sample Size 
120 eyes in two cohorts (60 in each cohort) 
IMD 
Disposable RESIGHT lenses 
Comparator device(s) 
Reusable RESIGHT lenses and Vitreq contact lens 
Maximum duration of 
treatment of a Participant 
Total inclusion time of each patient is surgery time (from first incision 
till removal of vitrectomy cannulas) 
Maximum duration of the 
Investigation 
Total inclusion time of each patient is surgery time (from first incision 
till removal of vitrectomy cannulas) 
Anticipate First Patient First 
Visit (FPFV) 
Q1 2023 
Anticipate Last Patient Last 
Visit (LPLV) 
Q4 2023 
Third Parties 
Carl Zeiss Meditec AG, Rudolf-Eber-Straße 11, 73447 Oberkochen, 
Germany: Grant 
 

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STUDY FLOWCHART 
Schedule of Events – Study specific Procedures / Assessments 
  Please indicate in the flowchart with different colors whether a procedure is performed as part of the standard of care or specifically for the Investigation. 
Describe the visits and applicable procedures/investigations (with a reference number or letter) in more detail in a footnote below the study flowchart 
Procedures/ Assessment 
Pre-surgery 
Surgery 
Timing (weeks) 
0 
0 
Informed consent 
X 1 
 
Inclusion / Exclusion criteria 
X 
 
Randomisation 
X 
 
Vitrectomy +/- Phaco paramaters 
 
X 
Device Deficiences 
 
X 
(Serious) Adverse event (S)(AE) assessment 
 
X 
 
 
 
 
 
 
I : Informed Consent process should take place prior to all other study-related procedures at the screening visit 
 
 

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1 Background and Rationale 
For several eye disorders, a surgical therapy is required. Depending on the type of surgery, different areas 
of the eye need to be visualized. For this purpose, a dedicated ophthalmic microscope is used. To view 
the anterior segment (i.e. the lens and all structures anterior to it), no additional optical attachment is 
required. To visualize the posterior segment (i.e. all structures posterior from the lens), an additional 
optical system is required in conjunction with the surgical microscope. 
 
 
 
 
Anatomy of the eye: anterior and posterior segment 

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1.1 Surgical microscope device  
For this purpose, a modern ophthalmic surgical microscope such as the ARTEVO 800 used in our center, 
integrates many functions. 
1.1.1 
Double binocular optical tract. 
 
 
Since stereopsis is required during surgery, both the main viewer and the assistant viewer have a binocular 
optical tract.  
 
1.1.2 
Red reflex 
During cataract surgery, it is required to visualize both the front and rear side of the lens. For this purpose, 
a co-axial light source is built in the microscope, which generates a red reflex by reflection from the retina 
in the back of the eye. The balance between red reflex light and environmental light can be controlled by 
surgeon.  
1.1.3 
Wide-angle retina viewing system 
During posterior segment surgery (vitrectomy), viewing of the retina is required. For that purpose, an 
 
The ARTEVO 800 digital 3D microscope system. 
Left: the microscope mounted on its floor stand, with touchscreen control pane on the microscope arml. Right: the 55” 3D 
visualization screen.  

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additional optical system below the microscope is required.  
These optical systems can be divided into two categories: 
 
1) 
Contact lens systems 
This lens type is placed on the corneal surface with some contact gel in between the cornea and the lens. 
Different lenses are being used, either with a convex surface for wide-angle viewing or with a flat (or 
concave) surface for high-magnification viewing. In the former lens type, an image inverter is required to 
generate an erect retina image for the surgeon.  
 
 
Although the optical quality of these contact lenses is very good, there are several disadvantages: 
- 
The continuous contact with the corneal surface may cause corneal lesions (epithelial defect), 
orcause corneal edema during prolonged surgery sometimes rendering retinal visualization 
impossible necessitating to discontinue the surgery. 
- 
The lens must be kept in a horizontal position on the eye, which requires an experienced surgical 
assistant to stabilize the lens during surgery. In our center, the surgical assistance is performed by 
residents in training who rotate every 6 weeks. Hence, it is impossible to have a well-trained surgical 
assistant for this purpose. 
- 
When using a wide-angle viewing lens, although an extreme wide-field angle can be obtained, this 
field-of view is highly limited be the pupil size. Since vitrectomy surgery is usually performed in 
patients >65 years of age, the pupil dilation is often limited, restricting the field-of view. 
 
As a result, the use of a contact lens during vitrectomy surgery is only occasionally used during surgery.  
 
 
 
 
 
             
 
Examples of contact lenses for intra-operative retina viewing.  
Left: wide-angle viewing lens, Right: high-magnification lens 

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2) Indirect ophthalmoscopy systems 
When using an indirect ophthalmoscopy lens system during surgery, a viewing lens is positioned a few 
millimeters above the cornea.  
Since there is no contact between the viewing lens and the cornea, there is no risk of cornea damage or 
edema. Also, the image generated is less dependent on the pupil size. 
A disadvantage is that an indirect ophthalmoscopy system generates an upside-down indirect image of the 
retina, which implicates that an inverting prism is always required to provide an erect retinal image for the 
surgeon. Moreover, the field-of-view of the presently available systems is still a little more limited compared 
to a convex contact lens in combination with a wide pupil. As a result, the surgeon may need to indent the 
eye during surgery to have a complete view of the retinal periphery.  
 
 
Drawing showing the light tract when performing surgery using a wide-angle contact lens. The size 
of the pupil determines the field-of-view of the surgeon. 
 
Eye indentation during surgery to see the retinal periphery. 
 

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There are several indirect ophthalmoscopy systems available for retinal surgery: 
- 
Haag-Streit Eibos (2) system.  
This surgical system was developed by late Prof. Dr. em Luc Missotten, former head of the ophthalmology 
dept of UZ Leuven. This system was used for more than 20 years on the microscope system used in our 
old operating theatre in the Sint-Pieter hospital. This system had a built-in inverting prism that omitted the 
need for an inverting mechanism in the microscope. However, this is a bulky device and is difficult (if not 
impossible) to clean and sterilize according to present standards.  
 
- 
Oculus BIOM system.  
This is a popular device that can be mounted under almost any brand of microscope. The ophthalmoscopy 
lens can be switched hence the surgeon can alternate between high and low magnification viewing. There is 
nowadays also a disposable version available. A main disadvantage is that when focusing the device, the 
distance between the ophthalmoscopy lens and the cornea changes, which often results in unwanted touch 
between the viewing lens and the cornea surface. 
 
 
Haag-Streit Eibos 2 system 

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- 
ZEISS RESIGHT system.  
Specifically for the Zeiss microscopes, the RESIGHT system can be used. This device is mounted below the 
microscope, and allows the surgeon to look through a lens which is held by a swing arm just above the 
surface of the eye. The RESIGHT system is highly integrated within the ZEISS LUMERA/ARTEVO 
microscopes, which has several ergonomical advantages. Firstly, the microscope automatically changes 
several settings (illumination, foot pedal control, inverting system, …) when the RESIGHT is inserted into 
the field-of-view. Secondly, the focusing can be done with the microscope foot pedal and the system focuses 
internally whereby the distance between the surgical lens and the cornea remains unchanged. 
Since the purchase of our LUMERA 700 (and later on: ARTEVO 800) microscopes, we have been using the 
RESIGHT system for all our vitrectomy surgeries.  
 
The RESIGHT provides two selectable lenses, the 60D (green one) and the 128D (yellow one). 
The yellow lens has lower magnification and more overview to allow good visualization of the periphery. 
The green lens provides higher magnification for macular surgery but as a consequence offers less overview 
in the eye. During vitrectomy for macular surgery, the lenses will be switched a few times by dialing the 
 
 
Oculus BIOM surgical viewing system: left: reusable, right: disposable 
 
Click on the thumbnail to view a short video on 
the practical use of the ReSight system 

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desired lens in front of the eye. During the vitreous removal and the lasering of the retina, the yellow lens 
is used. During the macular surgery (e.g. removal of epiretinal membrane or peeling of the inner limiting 
membrane), the green lens is used.  
At present, both RESIGHT lenses are reusable and are cleaned and sterilized (reprocessed) together with 
the RESIGHT system itself after every surgery. These reusable lenses are validated for 200 reprocessing 
cycles. We do notice that after a few dozen reprocessing cycles, wear & tear occurs which results in the 
following observations: 
• 
The lens surface shows scratches from the cleaning process, which deteriorates the surgeons’ view. 
• 
The lens surface shows stains, created by leftovers of the cleaning agents used. These stains become 
permanently “baked” into the lens surface due to the heat from the sterilization process.  
• 
Condensation occurs on the lower surface of the lens (closest to the eye surface), again hindering 
the surgeon’s view. 
 
1.1.4 
3D Viewing 
The ARTEVO 800 microscope head has two high-resolution (4K) cameras built-in, that allow the 
projection of a 3D image on a 55 inch screen. The surgeon can choose to perform the surgery using the 
screen while wearing (passive) 3D glasses. In this surgical mode, the surgeon is not looking through the 
microscope, but directly on the 3D screen to perform the surgery. However, for surgeons who prefer 
not to work on the 3D screen, the microscope can be switched to “hybrid” mode where the surgeon 
looks through the ocular of the microscope while the other people attending the surgery can view the 
image on the 3D screen. Even in the middle of a procedure, the surgeon can choose to switch between 
3D and hybrid mode by simply flipping a button on the microscope. Because of the high sensitivity of the 
4K cameras, less light is required compared to traditional oculars. Mainly during retina surgery using endo-
illumination, this makes the surgery safer by reducing the incidence of light-toxicity to the retina. 
Moreover, a smaller numerical aperture (‘diaphragm’) can be used for 3D visualization, which increases 
the depth-of-field compared to viewing through an ocular.  
However, a side-effect of the increased depth-of-field is that scratches / stains / condensation on the 
 
Picture of RESIGHT wide angle viewing system mounted underneath the ARTEVO microscope. 

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RESIGHT lens surface will be more visible. Hence, a clean optical pathway is mandatory for adequate 
visualization in 3D surgery.  
1.1.5 
Image layover 
During cataract surgery, a pre-operative photo of the eye (taken with the ZEISS IOLMASTER biometer) 
can be uploaded in the ARTEVO 800 microscope. Using an image recognition algorithm, the microscope 
can project additional information on the surgical image. This augmented reality system can show the 
surgeon the exact incision sites, the correct placement of the capsulorhexis (i.e. the opening that the 
surgeon makes in the front capsule of the lens), the axis of alignment of a toric implant lens that needs to 
be rotated in a correct angle in the eye etc.  
 
 
1.1.6 
iOCT 
Optical Coherence Tomography (OCT) was first introduced in ophthalmology in the mid-nineties for 
retinal viewing. Since then, the use of OCT has expanded extensively, and has now become one of the 
main technologies used for eye imaging, both in the anterior and the posterior segment. This OCT 
technology is now also available integrated in surgical microscopes (iOCT), and offers real-time 
visualization of the cornea, the lens and the retina.  
 
 
CALLISTO augmented reality: a live projection of the horizontal axis (yellow) and required positioning of a toric implant lens (blue) 
is available in overlay on the surgical image.  

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1.2 Disposable RESIGHT Lenses 
These wear & tear disadvantages can be overcome by using disposable lenses mounted on the RESIGHT 
system. Such disposable lens system compatible with the RESIGHT is already available from a third-party 
source (Oculus LenZ), but is not implemented in our center because of the high cost. Moreover, this 
Oculus LenZ is shaped to replace both the high-magnification 60D RESIGHT lens (green) and the wide-
field 128D RESIGHT lens (yellow), but this does not offer the same optical quality compared to each of 
these two separate lenses.  
 
ZEISS has designed a series of disposable lenses that are compatible with the RESIGHT system.  
1. WIDE-ANGLE LENS (Yellow) 
2. MACULA LENS (Green) 
3. 
ULTRA WIDE-ANGLE LENS (Purple) 
All three lenses are created from the same material: 
• 
Optical part: PMMA (poly-methyl methacrylate = ”plexiglas”) 
• 
Holder arm: ABS20 (acrylonitrile butadiene styrene; same material as Lego bricks) 
o 
MACULA LENS: color green 509 
o 
WIDE-ANGLE LENS: color yellow 408 
o 
ULTRA WIDE-ANGLE LENS: color traffic purple 854 
There materials are commonly used for medical applications and can be sterilized in ethylene-oxide 
without deformation, opacification or leaching.  
 
I had the opportunity to test these prototypes of these lenses on in vivo pig eyes in lab conditions. From 
these preliminary tests, the following conclusions were drawn: 
 
 
ARTEVO intra-operative OCT (iOCT): a vertical transsection of the retina can be viewed during surgery.  

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1. The disposable wide-angle lens has the same use as the present reusable yellow lens, but it’s 
improved design makes it possible to use this lens for both peripheral work as well as macula 
surgery.  
2. Macula lens: this lens has the same macula surgical use as the present reusable green lens. However, 
it’s improved resolution provides comparable or even better performance than a flat contact lens. 
3. Ultra-Wide angle lens: this newly designed lens provides the same wide-angle view as a convex 
contact lens, albeit without any contact with the corneal surface. However, this ultra-wide lens 
must be kept closer to the corneal surface compared to the yellow lens, hence may condensate 
more easily. 
 
Apart from the optical improvements, the use of disposable RESIGHT lenses is expected to also overcome 
the issues that we presently encounter when using the reusable lenses: 
• 
No scratches or stains on the lens surface since a brand-new lens is used in every surgery. 
• 
Not more (or minimum) condensation of the lens surface of the disposable lens as compared to the 
resuable lens since each disposable lens will have an intact coating. 
 
 
 
2 Objectives and Design 
2.1 Study objectives and hypotheses 
This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in 
routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further 
fine tune a device which can be used by other surgeons.  
Theoretically, both the improved lens design and better resistance to fogging should improve the 
visualization of the retina hence facilitate the surgery, increasing the surgical safety. 
 
During the surgery, a comparison will be done between the present lenses used (reusable RESIGHT lenses 
and disposable Vitreq contact lens) and the new disposable RESIGHT lenses. For that purpose, both lenses 
will be mounted on the rotating arm of the RESIGHT allowing the surgeon to toggle between both lenses 
during surgery. This toggling takes a few seconds, hence the total surgery time may be extended by ~30 
seconds. However, this will most likely not impact patient safety since a vitrectomy surgery typically 
requires one hour time.  
To compare the image generated by the present and the new RESIGHT lenses, both still shots and (short) 
video recordings will be created during the surgery. For this purpose, the internal camera and recording 
system of the ARTEVO microscope will be used. This will not have any impact on the surgery duration. 
Since only the retinal image is recorded, there is no risk of patient recognition on the recorded photos 
and videos.  

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Moreover, the Artevo microscope has a function that generates anonymous data export which will protect 
the patients’ identity.  
 
Although there is no contact between the lens and the patient, the lens is touched by the surgeons’ glove, 
hence must be sterile. ZEISS will deliver these lenses pre-sterilized according to the present required 
standards. ZEISS will provide these lenses packaged and labeled according to their specifications.  
 
 
 
2.2 Primary Endpoints 
The purpose of this study is to evaluate the intra-operative efficacy of new intra-operative viewing device, 
more specifically: 
1. To determine whether the performance of the disposable MACULA LENS is comparable or 
even better than a flat contact lens, due to its improved resolution. For this purpose, the in-
house available Vitreq contact lens will be used. 
This parameter will be determined in the macular surgery study arm only. 
2. To determine that the disposable ULTRA WIDE-ANGLE LENS does not condensate / 
condensates to a lesser extent during surgery.  
This parameter will be determined in both study arms. 
3. To determine that the disposable ULTRA WIDE-ANGLE LENS allows for imaging up to ora 
serrata on human eyes, reducing the need for indenting. This parameter will be determined in 
the retinal detachment surgery study arm only. 
4. To evaluate whether both peripheral vitrectomy as well as macula work are possible with the 
disposable wide-angle lens. This parameter will be determined in the macular surgery study arm 
only. 
5. To evaluate the amount of fogging that occurs when using the disposable wide-angle lens 
compared to using the reusable yellow lens. 
6. To evaluate whether the amount of light to illuminate the retina is reduced when using any of 
the disposable lenses compared to the reusable yellow/green lenses. This parameter will be 
 
 
Anonymous data export from ARTEVO microscope 

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determined in both study arms. 
7. To evaluate whether the disposable lenses show a more natural color representation compared 
to the reusable yellow and green lenses. This parameter will be determined in both study arms. 
8. To evaluate whether the iOCT quality recorded with the disposable macula lens is similar to or 
better than the iOCT recorded using the green reusable lens. This parameter will be determined 
in the macular surgery study arm only, where iOCT is being recorded as standard-of-care. 
 
2.3 Design of the Clinical Investigation 
Investigator-initiated, academic, mono-center, prospective, interventional case study.  No randomization 
will be performed. 
 
 
 
Sixty eyes will be enrolled in two study arms: 
• 
Group 1: 60 eyes that undergo primary vitrectomy surgery for retinal detachment 
• 
Group 2: 60 eyes that undergo macular surgery: pucker, vitreomacular traction or 
macular hole.  
The study duration for the participants starts from the moment the patient is informed.  
After the surgical procedure, the surgeon will record the parameters that are required to determine the 
primary outcomes of the study (§6). These parameters will be recorded in a Formasa form specifically 
designed for this study: see attached document. No information will be collected in this document that 
can identify the patients, the only clinical information used is the indication of the surgery (since this 
impacts the primary outcome parameters collected). After all patients (120 eyes) will we included in the 
trial, a KWS query will be used to export the Formasa forms. Only the content of these forms will be 
exported for statistical analysis. 
 
In case a device deficiency occurs (any issue that hinders the surgery when using a disposable RESIGHT 
lens), it will be recorded in the Device Deficiency form (see attachment). Additionally, any (Serious) 
Adverse Event resulting from such Device Deficiency will be recording in the (S)AE form (see attachment).  
 
2.4 Justification for the design of the Investigation 
The design of the study causes minimal influence on the clinical tract of the patient, since no supplementary 
study visits are required. In case of malfunctioning of the study lenses, minimal effort is required to restore 
the microscopic viewing system to the standard-of-cure with neglectable impact on the surgery duration.  
 
2.5 Expected Duration of the Investigation 
The study duration will be from the start of the surgical procedure till the end of the surgical 
procedure.  
RESIGHT Study
Group 1
Group 2

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The end of the Investigation will be notified by the investigator within 15 days of the end of the Investigation 
to the EC/CA.  
3 Eligibility Criteria 
3.1 Inclusion criteria 
Participants eligible for inclusion in this Investigation have to meet all of the following criteria: 
1. Voluntary written informed consent of the participant or their legally authorized representative 
has been obtained prior to any screening procedures 
2. 
Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment 
or macular disease (pucker, macular hole, vitreomacular traction). 
3. Both vitrectomy-only and combined phaco-vitrectomy surgeries 
4. General or local anesthesia, or combination 
5. Patients aged ≥ 18 years 
All participants that are considered for Investigation participation as per the above criteria, will be 
documented on the Screening Log, including Screen Failures.  
3.2 Exclusion criteria 
Participants eligible for this Investigation must not meet any of the following criteria: 
1. Patients aged < 18 years 
2. Patient who do not have sufficient command of the Dutch language to read and understand the 
informed consent form 
3. Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or 
compliance with the CIP. 
4. Repeat vitrectomy surgery 
Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled in 
the Investigation and will be identified on the Screening Log as Screen Failure. 
4 Study Procedures 
4.1 Participant consent and withdrawal of consent 
The Investigation will be conducted only on the basis of prior informed consent by the participants and/or 
their legally authorized representative(s). As such, no Investigation-related procedures will be conducted 
prior to obtaining written informed consent from potential participants. 
The process for obtaining and documenting initial and continued informed consent from potential 
participants will be conducted in accordance with ISO 14155:2020, applicable regulatory requirements and 
internal Standard Operating Procedures (SOPs). 
All originally signed obtained Informed Consent Forms (ICFs) must be retained/archived in the ISF at the 
Participating Site and must not be destroyed (even when a scanned copy is available) before expiration of 
the legal archiving term as defined in the CIP section entitled “Archiving”.  
Participants may voluntarily withdraw consent to participate in the Investigation for any reason at any time. 
The participant’s request to withdraw from the Investigation must always be respected without prejudice 
or consequence to further treatment. Consent withdrawal will be documented in the participant’s medical 
record. 
Study data and samples collected before withdrawal can be used in the study. No new study data or samples 
will be collected after withdrawal of the participant. 
 
4.2 Selection of Participants / Recruitment 
In our standard-of-care, patients are proposed to undergo vitrectomy surgery in the outpatient clinic. When 

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a patient agrees to be scheduled for surgery, he or she will be explained that we have an experimental 
surgical viewing system available that we’d like to use for the surgery, and that for this purpose, we want 
to collect the intraoperative data only. 
The moment when the informed consent form for the RESIGHT Disposable study is handed to the patient, 
will be at the same time when the vitrectomy informed consent form is also given to the patient (as is done 
in standard-of-care in all our patients). In elective surgery (e.g. macular pucker or floaters), the surgery is 
usually planned on another day than the day of the informed consent. In urgent surgery (e.g. retinal 
detachment), the surgery is usually performed the same day or the day after. Also in case of urgent surgery, 
there is a window of several hours between the moment of consent to the surgery and the surgery itself, 
since these non-scheduled interventions are scheduled only following after the scheduled surgery list. 
Hence, also in urgent surgery, the patient will have sufficient time to read and sign the informed consent 
form of the study. 
The clinical data that will be used for the study are not different from those obtained in the standard clinical 
path, which implicates that no extra or specific examinations need to be performed for this trial. 
 
4.3 Randomization Procedure (if applicable) 
Not Applicable. Two study arms will be created depending on the surgical indication. 
4.4 Premature discontinuation 
Participants may voluntarily discontinue from the Investigation treatment and/or prematurely end their 
participation in the Investigation for any reason at any time. In such case the Investigator must make a 
reasonable effort to contact the participant (e.g., via telephone, e-mail, letter) in order to document the 
primary reason for this decision. 
The Investigator may also decide at any time during the course of the Investigation, to temporarily interrupt 
or permanently discontinue the treatment if it is deemed that continuation would be detrimental to, or 
not in the best interest of the participant.  
Similarly, the Sponsor, EC or authorized regulatory authority can decide to halt or prematurely terminate 
the Investigation when new information becomes available whereby the rights, safety and well-being of 
participants can no longer be assured, when the integrity of the Investigation has been compromised, or 
when the scientific value of the Investigation becomes obsolete and/or unjustifiable. In case the Sponsor 
decides to temporary halt or prematurely end the Investigation, or to close a Participating Site in case of 
major non-compliance and/or critical safety issues, the Sponsor will notify the concerned EC/CA within 15 
days of early termination or temporary halt, providing a justification of the event. In the event that the 
sponsor has temporarily halted or early terminated the Investigation on safety grounds, the Sponsor will 
inform the EC/CA within 24 hours of the event. In absence of EUDAMED, local guidelines with regards to 
notifications and submissions to the concerned EC/CA will be followed. 
Circumstances requiring premature treatment interruption or discontinuation of the Investigation, include 
but are not limited to:  
• 
Safety concerns related to IMD or unacceptable intolerability 
• 
Investigation participation while in violation of the inclusion and/or exclusion criteria 
In any such case of early termination and/or treatment interruption/discontinuation, the Investigator will 
continue to closely monitor the participant’s condition and ensure adequate medical care and follow-up. It 
is recommended that follow-up information will be collected as follows: 
For participants whose status is unclear because they fail to appear for visits without stating an intention 
to discontinue or withdraw, the Investigator must make every effort to demonstrate “due diligence" by 
documenting in the source documents which steps have been taken to contact the participant to clarify 
their willingness and ability to continue their participation in the Investigation (e.g., dates of telephone calls, 
registered letters, etc.). 
A participant should not be considered lost to follow-up until due diligence has been completed. 

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5 Investigational Medical Device (IMD)  
Investigational Medical Device 
Name (& company brand) 
CE mark 
(Y – N - NA) 
Used within 
Indication (Y or 
N) 
Manufacturer of the 
device 
Single-use WIDE-ANGLE LENS from 
ZEISS 
N 
Y 
Carl Zeiss Meditec AG 
 
Single-use ULTRA WIDE-ANGLE LENS 
from ZEISS 
N 
Y 
Carl Zeiss Meditec AG 
 
Single-use MACULA LENS from ZEISS 
N 
Y 
Carl Zeiss Meditec AG 
 
Reusable 128D lens from ZEISS (yellow) 
Y 
Y 
Carl Zeiss Meditec AG 
 
(ref 30AL128D) 
Reusable 60D lens from ZEISS (green) 
Y 
Y 
Carl Zeiss Meditec AG 
(ref 30AL60DM) 
Vitreq disposable contact lens 
Y 
Y 
BVI / Vitreq 
(ref .VL00.D01) 
 
5.1 Intended use 
The device is intended to be used during ophthalmic surgery. 
 
5.2 Identification and description of the IMD 
See Investigator Brochure  
 
5.3 Instructions for use 
See section IFU in Investigator Brochure  
 
 
5.4 Device qualification and classification 
The device is intended for retinal visualization during vitreoretinal surgery, similar to its already existing 
reusable counterparts. It is manufactured by Carl Zeiss Meditec AG and delivered pre-packaged and 
sterilized. 
The device is non-active  Risk classification is low (Class Is) since there is no physical contact between the 
device and the patient.  
 
5.5 Device Accountability 
After delivery, the IMD will be stored at room-temperature (as prescribed by the 
manufacturer) and opened from its sterile packaging immediately prior to use. 
In the hospital, there is a standard procedure for returning faulty products. This procedure will be 
followed, similar to the standard clinical path. The IMD (used or un-used) will be returned to the manufacturer 
after the clinical investigation is completed. 
 
 

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6 Safety reporting 
6.1 Definitions 
The definitions and reporting requirements adopted in this CIP are based on the MDR 2017/745, ISO 
14155:2020 and the MDCG 2020-10/1 European guideline. 
6.1.1. Adverse Event (AE) 
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons, in the context of a clinical 
investigation, whether or not related to the investigational medical device. (MDR Article 2(57)) 
 
Note: 
1. This definition includes events that are anticipated as well as unanticipated events. 
2. This definition includes events occurring in the context of a clinical investigation related to the 
investigational device, the comparator or the procedures involved. For the purpose of safety reporting all 
activities related to the use of a medical device may be considered procedures. 
6.1.2. Serious Adverse Event (SAE) 
A SAE is any adverse event that led to any of the following: 
a) death, 
b)  serious deterioration in health of the subject, that resulted in any of the following: 
 
- life-threatening illness or injury, 
 
- permanent impairment of a body structure or a body function, 
 
- hospitalisation or prolongation of patient hospitalisation, 
- medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function, 
- chronic disease, 
c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. (MDR 
Article 2(58)) 
Note: Planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration in health, is not considered a serious adverse event. 
 
6.1.3. Adverse Device Effect (ADE) 
An ADE is an adverse event related to the use of an investigational medical device. 
Note 1: This includes any adverse event resulting from insufficiencies or inadequacies in the instructions 
for use, the deployment, the implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
Note 2: This includes any event that is a result of a use error or intentional misuse of the investigational 
medical device. 
 
6.1.4. Serious Adverse Device Effect (SADE) 
A SADE is an adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 
 
6.1.5 Unanticipated Serious Adverse Device Effect (USADE) 
An (USADE is an effect which by its nature, incidence, severity or outcome has not been identified in the 
current risk assessment. 

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6.1.5. Device Deficiency (DD) 
A DD is any inadequacy in the identity, quality, durability, reliability, safety or performance of an 
investigational device, including malfunction, use errors or inadequacy in information supplied by the 
manufacturer. 
For DD reporting, only non-CE marked surgical components described in the investigator brochure are 
considered as IMD.  
 
 
Specifically for this study, a faulty production of such lens could obscure the retinal visualization for the 
surgeon. However, this issue would be noticed by the surgeon at the very beginning of the surgery and 
the lens would be replaced by another disposable lens sample (or by a reusable lens).  
 
 
 
6.2 Adverse Events that do not require reporting 
In general, the following should not be reported as AEs: 
• 
Pre-existing conditions, including those found as a result of screening (these should be reported 
as medical history or concomitant illness). 
• 
Pre-planned procedures, unless the condition for which the procedure was planned has worsened 
from the first trial-related activity after the subject has signed the ICF. 
 
The following events are commonly observed and are therefore not considered as AEs for the purpose of 
the Investigation: adverse events that are related to malfunctioning of (an)other surgical device than the 
surgical microscope or the disposable RESIGHT lenses, e.g. the vitrectomy device.  
Although these events should not be reported to the Sponsor, these should be recorded in the patient’s 
medical notes according to routine practice. 
The following events are not to be considered as SAEs: 
• 
Pre-planned hospitalisations, unless the condition for which the hospitalisation was planned has 
worsened from the first Investigation-related activity after the subject has signed the informed 
consent.  
• 
Hospitalisation as part of a standard procedure for CIP therapy administration. However, 
hospitalisation or prolonged hospitalisation for a complication of therapy administration will be 
reported as an SAE. 
• 
Hospitalisation or prolongation of hospitalisation for technical, practical, or social reasons, in 
absence of an AE. 
6.3 Recording and reporting of Adverse Events 
Investigators will seek information on AEs during each patient contact. All events, whether reported by the 
patient or noted by the Investigation staff, will be recorded in the patient’s medical record and in the 
(e)CRF within a reasonable time after becoming aware. If available, the diagnosis should be reported on 
the AE form, rather than the individual signs or symptoms. If no diagnosis is available, the Investigator 
should record each sign and symptom as individual AEs using separate AE forms. 
The following minimum information should be recorded for each AE: 
- AE description 
- start and stop date of the AE 
- severity 
- seriousness 
- causality assessment to the IMD and/or Investigation procedures 
- outcome 

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6.3.1 
Assessment  
All AEs must be evaluated by an Investigator as to: 
 
• 
Seriousness: whether the AE is an SAE. See above for the seriousness criteria. 
 
• 
Severity:  
o 
Severity must be evaluated by an Investigator according to the following definitions: 
 
Mild – no or transient symptoms, no interference with the subject’s daily activities 
 
Moderate – marked symptoms, moderate interference with the subject’s daily 
activities 
 
Severe – considerable interference with the subject’s daily activities, unacceptable 
• 
Causality: 
 
Not related 
Relationship to the device, comparator or procedures can be excluded when: 
- the event has no temporal relationship with the use of the IMD, or the procedures related 
to application of the IMD; 
- the SAE does not follow a known response pattern to the medical device (if the response 
pattern is previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure – when clinically feasible – and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the SAE; 
- the event involves a body-site or an organ that cannot be affected by the device or 
procedure; 
- the SAE can be attributed to another cause (e.g., an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
- the event does not depend on a false result given by the IMD used for diagnosis, when 
applicable. 
 
In order to establish the non-relatedness, not all the criteria listed above might be met at 
the same time, depending on the type of device/procedures and the serious adverse event. 
Possible 
The relationship with the use of the IMD or comparator, or the relationship with procedures, 
is weak but cannot be ruled out completely. Alternative causes are also possible (e.g., an 
underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or 
treatment). Cases where relatedness cannot be assessed, or no information has been obtained 
should also be classified as possible. 
Probable 
The relationship with the use of the IMD or comparator, or the relationship with procedures, 
seems relevant and/or the event cannot be reasonably explained by another cause. 

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Causal relationship The SAE is associated with the IMD, comparator or with procedures beyond reasonable 
doubt when: 
- the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
- the event has a temporal relationship with IMD use/application or procedures; 
- the event involves a body-site or organ that 
• the IMD or procedures are applied to; 
• the IMD or procedures have an effect on; 
- the SAE follows a known response pattern to the medical device (if the response pattern 
is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the SAE (when clinically feasible); 
- other possible causes (e.g., an underlying or concurrent illness/clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the IMD used for diagnosis, when applicable; 
 
In order to establish the relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the SAE. 
 
6.3.2 
Timelines for reporting 
- 
After informed consent has been obtained, but prior to first use of the IMD, only AEs caused by 
an Investigation specific procedure should be reported 
- 
After first use of the IMD, AEs will be reported as follows: 
o 
All AEs, SAEs, and DDs will be reported until 7 days after last use of the IMD, or until last 
follow-up visit (whichever occurs first). 
All SAEs as defined in the CIP must be reported to the Sponsor within 24 hours of the investigation staff 
becoming aware of the event. The immediate report shall be followed by detailed, written reports. The 
immediate and follow-up reports shall identify subjects by code numbers.  
 
SAE details will be reported by the Investigator to the Sponsor: 
• 
By completing the SAE form in the (e)CRF  
If an authorised Investigator from the reporting site is unavailable, initial reports without causality 
assessment should be submitted to the Sponsor by a healthcare professional within 24 hours of becoming 
aware of the SAE, but must be followed-up by medical assessment as soon as possible thereafter. 
6.3.3 
Follow-up  
The Investigator must record follow-up information by updating the patient’s medical records and the 
appropriate forms in the (e)CRF. The worst case severity and seriousness of an event must be kept 
throughout the Investigation. 
SAE follow-up information should only include new (e.g., corrections or additional) information and must 
be reported within 24 hours of the Investigator’s first knowledge of the information. This is also the case 
for previously non-serious AEs which subsequently become SAEs. 
• 
All SAEs must be followed up until the outcome of the event is ‘recovered’, ‘recovered with 
sequelae’, ‘not recovered’ (in case of death due to another cause) or ‘death’ (due to the SAE) and 
until all related queries have been resolved, or until end of the Investigation (whichever occurs 
first). 

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• 
Non-serious AEs must be followed up until the patient’s last study visit, and until all related queries 
have been resolved. 
 
SAEs after the end of the Investigation: If the Investigator becomes aware of an SAE with suspected 
causal relationship to the IMD or experiment after the subject has ended the Investigation, the Investigator 
should report this SAE within the same timelines as for SAEs during the Investigation. 
 
6.3.4 
Pregnancy 
Female subjects must be instructed to notify the Investigator immediately if they become pregnant during 
the Investigation.  
 
6.3.5 
Death 
All deaths will be reported without delay to the Sponsor (irrespective of whether the death is related to 
disease progression, the IMD, study procedure or is an unrelated event). The Sponsor will notify all deaths 
as soon as possible after becoming aware to the EC and provide additional information if requested. 
6.4 Recording and reporting of Device Deficiencies 
Each DD must be documented by the Investigator in the source documents and reported to 
the Sponsor on a Device Deficiency form. 
If the DD leads to the occurrence of a (S)ADE, the (S)ADE must also be reported by the Investigator to 
the Sponsor on the appropriate forms and within the specified timelines. 
6.5 Reporting requirements to Ethics Committee’s (EC’s) and Competent 
Authorities (CA’s) 
The Investigator is responsible for ensuring that all safety events are recorded in the (e)CRF and reported 
to the Sponsor in accordance with instructions provided below. 
The Sponsor will promptly evaluate all SAEs and DDs against medical experience to identify and 
expeditiously communicate possible new safety findings to Investigators, ECs and applicable CA’s based on 
applicable legislation. 
6.5.1 
Sponsor’s reporting of Serious Adverse Events and Device Deficiencies 
The Sponsor is responsible to report to the CA’s where the Investigation has commenced: 
- 
Any SAE that has a causal relationship with the IMD, the comparator or the investigation 
procedure or where such causal relationship is reasonably possible; 
- 
Any DD that might have led to a SAE if: 
a) Appropriate action had not been taken, or 
b) Intervention had not occurred, or 
c) If circumstances had been less fortunate; 
- 
New findings/update in relation to already reportable events. 
These ‘reportable events’ must be reported within the following timelines: 
• 
A reportable event which results in imminent risk of death, serious injury, or serious illness that 
requires prompt remedial action for other patients/subjects, users or other persons or a new finding 
to it must be reported immediately, but not later than 2 calendar days after awareness by the 
Sponsor of a new reportable event or of new information in relation with an already reported event. 
• 
Any other reportable event or a new finding/update to it must be reported immediately, but not later 
than 7 calendar days following the date of awareness by the Sponsor of the new reportable event 
or of new information in relation with an already reported event. 

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6.5.2 
Annual reporting 
The Sponsor has the obligation to, once a year throughout the Investigation (or on request), submit a 
progress report to the EC’s and CA’s containing an overview of all SADEs occurred during the reporting 
period and taking into account all new available safety information received during the reporting period. 
6.5.3 
Overview reporting requirements 
 
WHAT 
HOW 
TO 
TIMELINES 
Investigator 
AE 
AE form 
Sponsor 
as defined in CIP 
SAE 
SAE form 
Sponsor 
asap, but no later than 3 
calendar 
days 
after 
awareness  
DD 
DD 
form  
+ 
AE/SAE 
form 
 
(if 
applicable) 
Sponsor 
as defined in CIP 
(exception: 
within 
3 
calendar days if considered 
reportable event) 
Death 
SAE form 
Sponsor 
asap 
Sponsor 
all 
reportable 
events 
(of 
all 
participating 
sites) 
EU 
SAE 
report form 
(excel)1 
- CA for Belgium -
> FAGG: via mail 
to ct.rd@fagg.be   
 
asap, but no later than 2 
calendar days (in case of 
risk of death or serious 
injury/illness that requires 
prompt remedial action 
for other patients, users 
or other persons)  
 
7 
calendar 
days   
(all 
other 
reportable 
events) 
Death 
SAE form + 
narrative 
- EC 
asap 
Annual Progress 
Report 
APR 
template 
- EC 
- CA for Belgium -
> 
FAGG: 
via 
Common 
European 
Submission 
Portal (CESP)  
annually 
1 The SAE report form in Excel format can be downloaded from the following web page: 
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-10-
2_guidance_safety_report_form_en.xlsx?web=1 
6.6 Data Safety Monitoring Board (DSMB) 
Not applicable  

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7 
Statistics and Data Analysis 
Statistical analysis will be performed in accordance with ICH E9; a detailed description of the analysis is 
provided in the study-specific Statistical Analysis Plan (SAP). ICH E3 and E8 will guide the structure and 
content of the clinical study report. 
The statistical analysis for the clinical investigation will be outsourced to a licensed medical statistician 
(Ars Statistica).  
A pseudonymized Excel-export will be generated from the eCRF for statistical analysis. 
 
7.1 Sample Size Determination 
120 eyes in 2 cohorts 
. 
7.2 Statistical Analysis 
 
7.2.1 
Efficacy Analysis 
All endpoints: For group comparisons, continuous data will be compared by means of T-test/ANOVA when 
homogeneity of variances, tested with the Bartlett’s test, and normality of the residuals, tested with the 
Shapiro-Wilks test, will be reached and means and standard deviations (means ± StDev) will be reported. 
When homogeneity of the variance or normality of the residuals will not be proved, Wilcoxon signed 
rank/Kruskal-Wallis test will be performed on rank data and medians and inter-quartile ranges (median 
[Q25 – Q75]) will be reported. Next, the dependence between two continuous variables will be studied 
through Pearson’s correlation. Last, for count data, the Pearson Chi-Squared test will be performed to 
compare proportions.  
7.2.2 
The level of statistical significance  
The statistical significance level will be 5% 
7.2.3 
Procedure for accounting for missing, unused and spurious data  
Missing data  
In case of missing values, the underlying missingness process (MCAR, MAR or MNAR) will be investigated 
and 5 multiple imputations will be performed using the MICE R package.  
We will test with the statistical test of Jamshidian and Jalal (2010), implemented in the MissMech R Package 
(Jamshidian, Jalal & Jansen,2014), whether missing data were MCAR. If they were not MCAR, we 
investigated whether or not the missing mechanism could be explained by baseline characteristics (eg, 
sociodemographic, medical features) of patients using logistic regression, which would suggest an MAR 
mechanism. If missing data were not MCAR or MAR, they were considered as MNAR. 
A sensitivity analysis will be performed on the primary outcome on the aggregated datasets from the 
multiple imputation. 
 
7.2.4 
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. 
 

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7.2.5 
Inclusion in analysis 
All eyes will be included in the analysis. 
 
 
7.3 Interim Analysis and Final Database Lock 
No interim analysis is planned. 
8 
Data handling  
Data handling and data flows for the Investigation are summarized below. 
An eCRF will be created on the RedCap platform, containing the following instruments: 
- 
Surgeons’ report on the disposable RESIGHT lens(es) used during surgery: same information as 
recorded in the Formasa form 
- 
Device Deficiency form 
- 
(Serious) Adverse Event form 
This platform provides all required functionality, security and traceability to be compliant with a CRF. To 
pseudonymize the patient data, a sequential data number will be created as study number not containing 
a link to any patient identification data using in the hospital. A separate file containing the EMR number of 
each patient linked to the study number (pseudonymized data) will be kept behind the hospital firewall, 
only accessible by the study personnel involved in this trial. 
 
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. 
 
All clinical investigation documentation will be kept for 25 years from the clinical investigation plan defined 
end of clinical investigation point. When the minimum retention period has elapsed, clinical investigation 
documentation will not be destroyed without permission from the sponsor. 
8.1 Data Collection Tools and Source Document Identification 
8.1.1 
Operational aspects  
Data collection, handling, processing and transfer for the purpose of this Investigation will be performed in 
compliance with applicable regulations, guidelines for clinical trials and internal procedures, as follows: 
8.1.1.1 
Data collection  
Source data will be collected and recorded in the participant’s files/medical records. 
If applicable, worksheets may be used for capturing some specific data in order to facilitate completion of 
the (e)CRF. Any such worksheets will become part of the participant's source documentation and will be 
filed together with or as part of the medical records (during but also following completion of the 
Investigation). 
It remains the responsibility of the Investigator to check that all data relating to the Investigation, as 
specified in the CIP, are entered into the (e)CRF in accordance with the instructions provided and that the 
forms are filled out accurately, completely and in a timely manner. 
(e)CRFs are provided by the Sponsor for each participant. The Investigation data will be transcribed from 
the source records (i.e., participant’s medical file or study-specific source data worksheets) into an (e)CRF 
by study staff. Transcription to the (e)CRF will be done as soon as possible after a participant visit and in a 
pseudonymized manner using a unique identifier assigned by the Sponsor. 

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The (e)CRFs will be available for review at the next scheduled monitoring visit (as applicable) and shall 
under no circumstances capture personal data, such as but not limited to the participant or their relative(s) 
name, home address, contact details, full date of birth medical record number (e.g., UZ Leuven EAD 
number), social security number etc.  
8.1.1.2 
Data Validation  
All data relating to the Investigation must be prepared and validated by the Investigator. Any (e)CRF entries, 
corrections and alterations must be made by the Investigator or other authorized study staff.  
Proper audit trails must be available to demonstrate the validity of the Investigation data collected. This 
includes historical records of original data entries, by whom and when the data was entered, as well as 
detailed records of any corrections or additions made to the original data entry (i.e., who made the 
correction/addition, when and why), without obliterating the original data entry information. 
8.1.1.3 
Data Management 
The Study Data Manager will perform extensive consistency checks on the received data. Queries will be 
issued in case of inconsistencies in accordance with internal procedures. A Data Management Plan (DMP) 
will be developed to map data flows, data validation measures that will be taken, how (interim) database 
lock(s) will be managed and, as applicable, the role and responsibilities of the Data Safety Monitoring 
Committee (DSMB). 
8.1.1.4 
Data Transfer 
Any participant records or datasets that are transferred to the Sponsor or any partners of the Sponsor 
will contain the study-specific participant identifier only; participant names or any information which would 
make the participant identifiable will not be transferred. All pseudonymized data relating to the Investigation 
must be transmitted in a secure manner to the Sponsor or any partners of the Sponsor (see 8.1.2. legal 
requirements). 
8.1.2 
Legal requirements 
All source data will be kept at a secured location with restricted access at all times. These data must be 
collected and processed with adequate precautions to ensure confidentiality and compliance with applicable 
data protection laws and regulations and more in particular with the GDPR, and relevant national laws 
implementing the GDPR. Appropriate technical and organizational measures to protect the data against 
unauthorized disclosure or access, accidental or unlawful destruction, or accidental loss or alteration must 
be established. Study staff whose responsibilities require access to personal data agree to keep the data 
confidential. 
The Investigator and the Participating Site(s) (as applicable) shall treat all information and data relating to 
the Investigation disclosed to them as confidential and shall not disclose such information to any third 
parties or use such information for any purpose other than the objectives of the Investigation as described 
in this CIP. The collection, processing and disclosure of personal data, such as participant health and medical 
information, is subject to compliance with applicable laws and regulations regarding personal data 
protection and the processing of personal data. 
The Investigator will maintain all source documents and completed (e)CRFs that support the data collected 
from each participant, and will maintain a TMF/ISF containing all study documents, as specified in ISO 
14155:2020 Annex E entitled “Essential clinical investigation documents”, and as specified by applicable 
regulatory requirement(s). The Investigator will take appropriate measures to prevent accidental or 
premature destruction of these documents. 
Transfer of the pseudonymized data will be performed via a secured method of transfer taking into account 
all applicable security arrangements and regulations (such as the GDPR). 
8.2 Audits and Inspections 
The Investigator will permit direct access to study data and documents for the purpose of monitoring, 
audits and/or inspections by authorized entities, such as but not limited to: the Sponsor or its designees 
and competent regulatory or health authorities. As such, (e)CRFs, source records and other study related 
documentation (e.g., ISF, TMF, pharmacy records, etc.) must be kept current, complete and accurate at all 
times. 

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8.3 Monitoring 
In accordance with ISO 14155:2020, the Sponsor is responsible for monitoring the Investigation to ensure 
compliance with GCP and current legislation, and to verify, among other requirements, that proper written 
informed consent has been obtained and documented, that the study procedures have been followed as 
shown in the approved CIP, and that relevant study data have been collected and reported in a manner 
that assures data integrity. To this end, source data will be compared with the data recorded in the (e)CRF. 
A risk-based approach will be applied to determine the extent of monitoring activities and monitoring of 
the Investigation will be performed by qualified individuals (independent from the site study staff), as 
applicable. 
UZ Leuven Clinical Trial Center (CTC) performs a risk analysis to determine the monitoring strategy. 
Based on this risk assessment, the clinical trial was classified as intermediate risk’ as the potential risks 
associated to study procedures and protocol design are markedly higher to that of standard medical care 
since the IMD has no CE label.  
However:  
- The IMD is non-invasive and will not collect other or more parameters than already collected during 
standard of care practices. 
- Safety risks associated with trial participation are lower or equal to standard of care. 
- No medical decisions are taken (solely) based on the output of the intervention with the IMD. 
- The duration of trial participation for each subject is short (1 examination only). 
  
Based on the above risk assessment and as permitted by ICH-GCP (r2) section 5.0.4, the Sponsor of the 
trial accepts the minimal risks associated with this trial and determines that monitoring activities (as 
defined by ICH-GCP E6(r2) §1.38) by a qualified individual, independent of the study team, is not 
necessary as it will provide little or no added value in protecting the safety of trial participants and 
assuring the integrity of collected trial data. Nonetheless, the UZ Leuven study team will take all possible 
measures to assure the quality and integrity of trial data and to safeguard the safety and wellbeing of trial 
participants, in accordance with the requirements set out in ICH-GCP(r2) and ISO:14155. 
8.4 Archiving  
As specified in ISO 14155:2020 section 8.6, the Sponsor and Investigator/Participating Site will maintain a 
record of the location(s) of all respective Essential Clinical Investigation Documents (including but not 
limited to Source Documents, completed and final (e)CRF and ISF/TMF). The Sponsor should ensure that 
the Investigator has control of and continuous access to the (e)CRF data reported to the Sponsor during 
the Investigation. 
The Investigator/Participating Site should have control of all Essential Documents and records generated 
by the Investigator/Participating Site before, during and following termination of the Investigation. 
The Sponsor and Investigator is responsible for archiving study specific documentation (such as but not 
limited to the CIP, any amendments thereto, the final Clinical Study Report (CSR) and the study database), 
according to ISO 14155:2020. Source data and site-specific study documents (such as but not limited to 
the original signed ICFs) will be archived by the Participating Site(s) according to local practice, and for a 
period of at least 10 years after the clinical Investigation with the device in question has ended, or, in the 
event that the device is subsequently placed on the market, at least 10 years after the last device has been 
placed on the market.1 Archived data may be held on electronic record, provided that media back-up exists, 
hard copies can be obtained, if required and measures are taken to prevent accidental or premature loss 
or destruction of data. Destruction of Essential Documents prior to, during or upon completion of the 
required archival period, will require written authorisation from the Sponsor. 
 
1 According to UZ Leuven policy, Study documents will be archived for at least 25 years following termination of 
Investigation. 

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9 
Ethical and Regulatory Considerations 
9.1 Ethics Committee (EC) review & reports  
Before the start of the Investigation, this CIP and other related documents (e.g., ICF, advertisements, IB, 
etc.) will be submitted for review to the EC and to the relevant CA for authorization. The Investigation 
shall not commence until such approvals have been obtained. 
It is the responsibility of the CI to produce the APR and submit to the EC/CA within 30 days of the 
anniversary date on which favourable opinion to start the Investigation was given, and annually until the 
Investigation is declared ended. 
The CI must notify the EC/CA of the end of the Investigation. This notification must be made within 15 
days of the end of the Investigation. For multinational investigations, the concerned CA will be notified 
when the Investigation ends in its country. The CI will notify the Belgian CA when the Investigation has 
ended in Belgium and when the Investigation has ended in all participating countries. In absence of 
EUDAMED, local guidelines with regards to end of investigation notification will be followed. The Sponsor 
must notify the CA in case of a temporary halt or early termination of the Investigation. This notification 
must be made within 15 days of the temporary halt or early termination, providing a justification of the 
event. In the event that the Sponsor has temporarily halted or early terminated the Investigation on safety 
grounds, the CA must be informed within 24 hours of the event. 
The CI will submit a final report with the results of the Investigation, including any publications/abstracts, 
to the EC/CA within 1 year of Investigation termination, or within 6 months for paediatric Investigations. 
In case of a temporary halt or early termination this report must be provided within 3 months. 
 
9.2 Peer review  
Not applicable  
9.3 Regulatory Compliance 
The Investigation will be conducted in compliance with the principles outlined in the requirements for the 
conduct of clinical investigations in the EU, as provided for in the MDR, as applicable, and any subsequent 
amendments, as well as in compliance with ISO 14155:2020, other GCP guidelines, the most recent version 
of the Declaration of Helsinki, the Belgian law of May 7th, 2004 regarding experiments on the human person 
(as amended), or the Belgian law of December 22nd, 2020 concerning medical devices, as applicable, the 
Belgian royal decree of May 18th, 2021 concerning clinical investigations of medical devices,  and with the 
GDPR, the relevant Belgian laws implementing the GDPR, the Belgian Law of August 22nd, 2002 on patient 
rights, and all other applicable legal and regulatory requirements. 
9.4 CIP / GCP compliance 
The Investigation must be performed in accordance with the CIP, ISO 14155:2020, and applicable 
regulatory and country-specific requirements. ISO 14155:2020 is an international ethical and scientific 
quality standard for designing, conducting, recording and reporting clinical investigations that involve the 
participation of human participants. Compliance with this standard provides public assurance that the rights, 
safety and well-being of participants are protected, consistent with the principles that originated in the 
Declaration of Helsinki, and that the study data are credible, reliable and reproducible. 
The Investigator and study team acknowledge and agree that prospective, planned deviations or waivers to 
the CIP are not permitted under applicable regulations on clinical investigations. However, should there be 
an accidental CIP- deviation, such deviation shall be adequately documented in the source documents and 
on the relevant forms and reported to the CI and Sponsor. Deviations should also be reported to the EC 
as part of the EC’s continued review of the Investigation (e.g., through the ASR, APR, etc.). CIP deviations 
which are found to frequently recur, will require (immediate) action. The Investigator acknowledges that 
such recurring CIP deviations could potentially be classified as a serious violation of ICH and/or the CIP. 
It is understood that “a serious violation” is likely to affect to a significant degree: 
- 
the safety or physical or mental integrity of the participants; or 

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the scientific validity of the Investigation 
The Investigator is expected to take any immediate action required to protect the safety of any participant 
included in the Investigation, even if this action represents a deviation from the CIP. In such cases, the 
Sponsor should be notified of this action and the EC should be informed according to local procedures and 
regulations. 
9.5 Data protection and participant confidentiality 
The Investigation will be conducted in compliance with the requirements of the GDPR, the relevant Belgian 
laws implementing the GDPR, including the Belgian Privacy Act of July 30th, 2018 on the protection of 
privacy in relation to the processing of personal data. Any collection, processing and disclosure of personal 
data, such as participant health and medical information is subject to compliance with the aforementioned 
personal data protection laws (cfr. Data Processing Annex (DPA) in Appendix). In case personal data is 
transferred outside the European Economic Area, safeguards will be taken to ensure that appropriate 
protection travels with the data in accordance with the GDPR (https://ec.europa.eu/info/law/law-
topic/data-protection/international-dimension-data-protection/rules-international-data-
transfers_en#documents) 
Any personal data shall be treated as confidential at all times including during collection, handling and use 
or processing, and the personal data (including in any electronic format) shall be stored securely at all times 
and with all technical and organizational security measures that would be necessary for compliance with 
EU and national data protection legislation (whichever is more stringent). The Sponsor shall take 
appropriate measures to ensure the security of all personal data and guard against unauthorized access 
thereto or disclosure thereof or loss or destruction while in its custody. 
9.6 Insurance 
The Sponsor, Participating Site and the Investigator shall have and maintain in full force and effect during 
the term of this Investigation, and for a reasonable period following termination of the Investigation, 
adequate insurance coverage for: (i) medical professional and/or medical malpractice liability, and (ii) general 
liability. 
Article 32 of the Belgian Law concerning medical devices dated December 22nd, 2020 applies. Prior to the 
start of the Investigation, the Sponsor shall enter into an insurance contract in order to adequately cover 
participants from Belgian Participating Sites in accordance with Article 32 of the said law. 
 
9.7 Amendments 
As specified in ISO 14155:2020 section 7.5.1, amendments must not be implemented prior to EC and/or 
CA review and/or approval, as applicable. Under emergency circumstances, deviations from the CIP to 
protect the rights, safety or well-being of human subjects may proceed without prior approval of the 
sponsor and the EC/CA as applicable. Such deviations shall be documented and reported to EC/CA as soon 
as possible. 
In accordance with the Belgian law of December 22nd, 2020 concerning medical devices, the Sponsor may 
develop a non-substantial amendment at any time during the Investigation. If a substantial amendment is 
introduced to the CIP, or the documents that supported the original application for the clinical 
Investigation, authorisation is needed, the Sponsor must submit a valid substantial amendment for approval 
to the EC/CA. The EC/CA will provide a response in accordance with timelines defined by applicable law. 
It is the Sponsor’s responsibility to assess whether an amendment is substantial or non-substantial. In 
absence of EUDAMED, local guidelines with regards to notifications and submissions to the concerned 
EC/CA will be followed. 
Amendments to the Investigation are regarded as ‘substantial’ when they are likely to have a substantial 
impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data 
generated by the investigation.  
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2010_c82_01/2010_c82_01_en.pdf  

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9.8 Post-Study activities 
Not applicable  
10 Research Registration, Dissemination of Results and 
Publication Policy 
The Declaration of Helsinki (most recent version) and European and Belgian regulations require that every 
research involving human participants be registered in a publicly accessible database before recruitment of 
the first participant. The CI is responsible for registering the Study.  
In addition, the CI will fulfil its ethical obligation to disseminate and make the research results publicly 
available. As such, the CI is accountable for the timeliness, completeness and accuracy of the reports. 
Researchers, authors, sponsors, editors and publishers must adhere to accepted guidelines for ethical 
reporting. Negative and inconclusive, as well as positive results, must be published or otherwise made 
publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in 
publication.  
10.1 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 data will be analyzed and tabulated, 
and a clinical investigation report will be prepared in accordance with ISO14155:2020. 
 
10.2 Publication  
The Principal Investigator intends to publish the obtained study data in a specialized journal for retinal 
surgery. 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 to give feedback on the manuscript within 4 weeks. It is up to the Principal Investigator to decide 
to make any changes to the manuscript based on this feedback. 
 
11 Intellectual Property 
Any know how, inventions, methods, developments, innovations, discoveries and therapies, whether 
patentable or not, arising from the Investigation or made in the performance of the CIP (“Inventions”) shall 
vest in the Sponsor. If the Investigation is multicentric, the Participating Site, its employees and 
Investigator(s) shall promptly disclose to the Sponsor any such Inventions. The Sponsor and the 
Participating Site have expressly agreed that any and all study data as collected and prepared in the 
performance of the CIP shall be the sole property of the Sponsor, unless otherwise agreed in the 
Investigation agreement between the Sponsor and the Participating Site. 
12 Joint Commission International (JCI) 
In order to ensure the same quality and safety standards in patient care for clinical research as commonly 
applied by the Sponsor in its regular activities, and in accordance with JCI standards, the Sponsor shall 
comply with the following obligations: (a) the Sponsor will use trained and qualified employees or 
contractors to manage and coordinate the Investigation; (b) the Sponsor will ensure that multi-center 
Investigation reporting is reliable and valid, statistically accurate, ethical, and unbiased. (c) the Sponsor will 
not grant incentives, other than standard compensations and reimbursement of costs, to participants or to 
Participating Site’s staff that would compromise the integrity of the research; (d) the Sponsor is responsible 
for monitoring and evaluating the quality, safety, and ethics of the Investigation and will respect the 

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participating site’s policies and processes when performing such monitoring and evaluation activities; (e) 
the Sponsor will protect the privacy and confidentiality of the participants in accordance with all applicable 
laws. 
13 References 
Visualization during surgery: 
1. Visualization of the retina and vitreous during vitreoretinal surgery: new technologies. Sarah P 
Read, Jorge A Fortun. Curr Opin Ophthalmol . 2017 May;28(3):238-241. 
2. Outcome of primary rhegmatogenous retinal detachment using microincision vitrectomy and 
sutureless wide-angle viewing systems. Chun-Ting Lai, Wei-Hsun Kung, Chun-Ju Lin, Huan-
Sheng Chen, Henry Bair, Jane-Ming Lin, Wen-Lu Chen, Peng-Tai Tien, Yi-Yu Tsai. BMC 
Ophthalmol. 2019 Nov 19;19(1):230. 
 
Intra-operative adverse events: 
3. Pars plana vitrectomy for vitreomacular traction syndrome: a systematic review and 
metaanalysis of safety and efficacy. Jackson TL, Nicod E, Angelis A, Grimaccia F, Prevost AT, 
Simpson AR, Kanavos P. Retina. 2013 Nov-Dec;33(10):2012-7 
4. United Kingdom National Ophthalmology Database Study of Vitreoretinal Surgery Report 3, 
Retinal Detachment. Timothy L. Jackson, PhD, FRCOphth, Paul H.J. Donachie, MSc, Ahmed 
Sallam, PhD, FRCOphth, John M. Sparrow, DPhil, FRCOphth, Robert L. Johnston, FRCOphth. 
Ophthalmology 2014;121:643-648 
5. The Royal College of Ophthalmologists’ National Ophthalmology Database Study of 
Vitreoretinal Surgery Report 6, Diabetic Vitrectomy. Timothy L. Jackson, PhD, FRCOphth; 
Robert L. Johnston, FRCOphth; Paul H. J. Donachie, MSc; TomH. Williamson, MD, FRCOphth; 
John M. Sparrow, DPhil, FRCOphth; David H.W. Steel, FRCOphth. JAMA Ophthalmol. 
2016;134(1):79-85. doi:10.100 
6. United Kingdom National Ophthalmology Database Study of Vitreoretinal Surgery: Report 2, 
Macular Hole. Timothy L. Jackson, PhD, FRCOphth, Paul H. J. Donachie, MSc, John M. Sparrow, 
DPhil, FRCOphth, Robert L. Johnston, FRCOphth. Ophthalmology 2013;120:629–634 
7. The Royal College of Ophthalmologists’ National Ophthalmology database study of vitreoretinal 
surgery report 4, epiretinal membrane. Timothy l. Jackson, phd, frcophth, Paul h.j. Donachie, 
msc, Tom h. Williamson, md, frcophth, John m. Sparrow, dphil, frcophth, Robert l. Johnston, 
frcophth. Retina 35:1615–1621, 2015 
 
Surgical technique of (phaco)vitrectomy: 
8. Stalmans P, A Comparative Study of 23-Gauge and 27-Gauge Vitrectomy for Puckers or 
Floaters, Including Evaluation of the Effect of Combined Phaco-Vitrectomy Surgery on 
Postoperative Outcome. Ophthalmologica, Ophthalmologica. 2021;244(3):245-249. 
 
 
 

UZ Leuven – KU Leuven 
 
 
Protocol: RESIGHT Disposable 
Internal Ref.: S67415 
 
 
Version 1.0 07MAR2023 
 
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Appendices 

UZ Leuven – KU Leuven 
 
 
Protocol: RESIGHT Disposable 
Internal Ref.: S67415 
 
 
Version 1.0 07MAR2023 
 
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Appendix 1: Clinical Investigation Plan history 
 
Original CTP version: 
1.0 dated 7/03/2023 
 
Amendment #1: 
<CIP version number> dated 7/03/2023 
Modifications made / Reason for amendment: 
<CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
 
Amendment #2: 
<CIP version number> dated 7/03/2023 
Modifications made / Reason for amendment: 
< CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
< CIP section reference> 
<describe modifications made> 
 
 
 

UZ Leuven – KU Leuven 
 
 
Protocol: RESIGHT Disposable 
Internal Ref.: S67415 
 
 
Version: 1.0 07MAR2023 
 
CTC GEN-TMP-005-1.0_28Sep2022  
Page 43 of 43                              Protocol template for clinical 
investigation 
                                                                                   Confidential & Proprietary                with IMD, without CE-label or used off-label 
Appendix 2: Data Processing Annex (DPA) between Sponsor 
and Participating Site(s) 
 
Not applicable: single site study UZLeuven  
 
Appendix 3: Hyperlink to RESIGHT video 
Click on the thumbnail to view a short video on the practical use of the ReSight system 
Appendix 4: Case Report Form in RedCAP 
PDF export from RedCap eCRF 
Appendix 5: Device Deficiency Form in RedCAP 
PDF export from RedCap eCRF 
Appendix 6: Adverse Event Form in RedCAP 
PDF export from RedCap eCRF