Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
Phase: NA
Conditions: Nearsightedness
Sponsor: Université de Montréal

 
 
TITLE OF THE STUDY 
 
NCT number: 
 
 
Internai RIB number: 
DOCUMENT 
DATE OF APPROVAL 
Effect of Defocus in Soft Contact Lenses on Internai Retinal Vascularization 
not available 
 
CERC- 2024- 5133 
 
Protocol including statistical analysis plan and Informed Consent Form 
April 9, 2024. 

 
 
 
 
 
 
 
 
 
PROTOCOL OF A CLINICAL STIJDY 
 
 
 
 
Title: EFFECT OF DEFOCUS IN SOFT CONTACT LENSES ON INTERNAL 
RETINAL VASCULARIZATION 
 
 
 
 
Principal investigator 
Langis Michaud, O.D, M.Sc 
 
 
In collaboration with 
 
Rémy Marcotte-Collard, O.D, M.Sc. PhD candidate 
Oleksandra Pyssarenko, undergraduate student 
Catherine Forest , undergraduate student 
 
Partnership: Bausch and Lomb. Role: to supply the contact lenses studied. 
 
Location: School of Optometly Clinic, Uni versité de Monti·éal 
 
 
 
 
 
 
Date of approval:  April 9, 2024 
 
 
NCT number: not available 
Internai IRB ref number: CERC 2024- 5133 

2 
 
Table of contents 
I. 
Surnmruy of the study .......................................................................................................................... 3 
II. Project description .................................................................................................................... 4 
1) Literature review ...................................................................................................................... 4 
Myopia ...................................................................................................................................... 4 
The choroid ......................................................................................................................... 5 
Retinal vascula1iz ation ................................................................................................................. 6 
2) Study objectives ....................................................................................................................... 8 
3) Assumptions ............................................................................................................................. 9 
4) Materials and methods ................................................................................................................. 9 
a. 
Seru·ch quota.tian ............................................................................................................. 9 
b. 
Study population, sampling and recrnitmentprocedures .................................................. 9 
c. 
Data collectionprocedure .............................................................................................. 11 
d. 
Desc1iption ofvariables ................................................................................................ 14 
e. 
Desc1iption of lenses used  ................................................................................................. 1. 4 
f. Description of measuring inshllillents ............................................................................................ 15 
f. 
Statistical analysis plan ............................................................................................................... 16 
g. 
Sample size justification ............................................................................................... 16 
5) Ethical considerations ................................................................................................................ 17 
6) Relevanceand anticipated benefits ........................................................................................ 18 
7) Timetable ................................................................................................................................................ 18 
m. Bibliography ........................................................................................................................................ 19 
IV. Appendix 1..................................................................................................................................... 21 
V. Appendix 2 ................................................................................................................................. 21 
VI. Appendix 3 ............................................................................................................................... 22 
VII. Appendix 4 .............................................................................................................................. 23 

3 
 
I. Summaiy of the study 
 
Objective: The aim of this reseai·ch project is to gain a better understanding of the retinal 
vasculai· changes that occur in response to the optical effect of a myopie defocus daily 
disposable contact lens used in reseai·ch project 19_09_27_CERC-19-071P at the Université 
de Montréal. The present study will be can ied out on patients aged between 18 and 35, to 
investigate the physiological changes  brought about by this lens. The prima1y objective of 
this study is to quantify retinal vascular density in the superficial and deep plexus following 
one week's wear of a high peripheral add soft contact lens (myopie defocus). The seconda1y 
objective is to evaluate changes in choroidal thickness at the macular level after one week's 
wear of the high peripheral addition soft contact lens (myopie defocus). 
Materials and methods: 25 myopie paiticipants aged between 18 and 35 will be selected. Each 
participant will wear a single-vision spherical design soft lens for one week and a peripheral 
addition soft lens for the same duration. The order in which participants wear the two types 
of lenses will be detennined randomly. They will be asked to attend three different visits, 
one week apait. At visit #1, initial measurements of deep and superficial plexus blood vesse! 
density and choroidal thickness will be taken with an angiographie optical coherence 
tomograph (OCT-ATriton). These measurements will be re-evaluated at each visit to assess 
the changes brought about by each type of lens. The results obtained will be compared 
between the three visits cai1-ied out for each part icipant. 
Hypothesis: It is expected that one week's wear of the pe1-ipheral myop ie defo cus contact 
lens will cause an increase in blood vesse! density and a thickening of the choroidcompared 
with initial measurements in young adults. A decrease in blood vessel density and choroidal 
thinning is expected after one week's wear of the spherical soft lens (hyperopic defocus), 
compared with initial measurements. 

4 
 
II. Project description 
 
1) Literature review 
 
Myopia 
The prevalence of myopia is rising rapidly, and an inevitable increase in the number of cases 
is expected over the next few years. The WHO rep01ts that the prevalence ofmyopia is 
expected to reach 50% of the world's population by 2050. An increase in the number of 
cases ofhigh myopia is also predicted, with 10% of the population affected. (1). The onset 
and rapid progression of myopia is observed particularly in children and adolescents. 
However, this phenomenon remains frequent in young adults aged between 20 and 30, who 
have a heavy workload in near vision (2). 
 
Myopia is defined as a refractive disorder in which light rays passing through the pupil fo1m 
a focused image at the front of the retina, with bluned distance vision as the main symptom. 
(3). This disorder can easily be conected with glasses or contact lenses (4). Myopia can be 
characterized as refractive, axial or mixed. Axial myopia is caused by an elongation of the 
eye's length, while refractive myopia refers to a high degree of curvature of the cornea or 
lens. Mixed myopia combines an elongated eye with a more cambered comeal cmvature. 
When myopia progresses in a patient, imaging techniques (axial length measurement and 
keratometric measurement) make it easier to identify which stru ctural component is plimalil 
y responsible for the change. (3). Myopia becomes problematic when it results in excessive 
elongation of the eye's length (axial myopia) (4). 
 
Projected data on the increase in high myopia are wonying, as it is associated with several 
ocular complications. In fact, it is associated with a higher risk of retinal detachment, 
cataracts, open-angle glaucoma and maculopathy (see table below). Visual impairment 
seconda1y to macular disorder is often caused by choroidal neovascularization, macular 
hole, cenu·al chorioretinal atrophy, foveoschisis, Brnch's membrane rnpture, retinal serous 
detachn1entor epiretinal membrane (5). These complications are paiticularly common in 
severe myopes (-6.00 or more), but also apply to less severe cases (6-8). The risk of 

5 
 
 
 
developing myopie maculopathy has been associated in paiticular with high axial length, 
as well as low choroidal thickness (8) 
 
 
 
Table 1: Risk of ocular complications according to myopia level (9) 
 
 
Glaucoma 
ùtaract 
(PSCC) 
Retlnal 
d etachment 
Myopie 
Maculopathy 
2.3 
2.1 
3.1 
2.2 
3..3 
3.1 
9 .0 
9 .7 
3.3 
5.5 
21.5 
40.6 
44.2 
126.8 
 
 
The choroid 
The choro id is a highly vascularized strncture of the eye whose main function is to provide 
nutrition for photoreceptors through the pigment epithelium layer (RPE) (10). Recent 
studies suggest that the choroid also plays an imp01tant role in eye elongation (11). One 
explanat ion put forward is that the choroid produces several growth factors that could 
explain the possible presence of a biochemical cascade that would dictate elongation in the 
eye (11, 12). 
 
In humans, sh01t-te1m vai·iation in choroidal thickness has been linked to several factors 
such as diurnal variations, physical activity, caffeine, light intensity and wavelength, as 
well as retinal defocus (13). 
 
Several studies have demonstrated the effect of myopie or hype1m etropic defocus on 
choroidal thickness and axial eye length. Hypermetropic defocus (negative lens) produces 
an image behind the patient's retina. A number of studies havedemonstrated that this type 

6 
 
of defocus helps to reduce choroidal thick:ness and increase axial length. This optical effect 
can be observed in conventional methods of myopia conection (single vision optical glasses 
and single vision spherical contact lenses). The principle of myopie defocus (positive lens) 
produces an image in front of the patient's retina. Studies have shown that this type of lens 
triggers a signal that allows the choroid to thicken, thereby decreasing axial length when 
the defocus targets the perifoveal region (14, 15). This latter optical process is used in a 
number of myopia control treatments, such as soft contact lenses, spectacle lenses and 
orthokeratology contact lenses, to reduce axial elongation. The primaiy aim of these 
different treatments is to reduce the hypermetropic defocusing on the peripheral retina that 
occurs in myopes. To achieve this, a variable add value is generated in the periphe1y of the 
various optical designs to create a positive spherical abe1rntion that brings the focus of 
peripheral rays fo1wai·d of the retina (16-18). 
 
Retinal vasculai-ization 
The retina is vascularized by two distinct systems, each supplying either the inner or outer 
p01tion of the retina. The choroid contains a layer of choriocapillaris that feed the retinal 
pigment epithelium and photoreceptors. The inner pait of the retina is vascularized by the 
central retinal aitery, which emerges at the head of the optic ne1v e. This <livides into three 
plexuses thatsupply different layers of the retina. The superficial plexus is the most anterior 
and feeds the innem1ost layers, i.e. the ne1ve fiber layer and the ganglion cell layer. The 
inte1mediate plexus lies between the ganglion cell layer and the inner nuclear layer. Finally, 
the deep plexus lies between the inner and outer nuclear layers. These three plexuses can 
be visualized using the OCT-A imaging technique (19). Changes in retinal blood flow are 
associated with changes in retinal vasculai· density (20). It is therefore possible to deduce 
that an increase in retinal vesse! density translates into an increase in blood flow. High 
myopia is a disorder that can lead to a number of ocular pathologies, as mentioned earlier. 
The pathological mechanism by which these pathologies develop in this condition is still 
poorly understood, but could be explained by the presence of oxidative stress. This 
oxidative stress could be partly responsible for disrnpting the mechanism of axial 
elongation, while also causing damage to the various strnctures of the eye. Improving 

7 
 
retinal blood flow in such patients could be a beneficial factor in eliminating the retinal 
hypoxia caused by oxidative stress (21) 
 
Figure 1: Diagram of the biochemical cascade of oxidative stress in the retina (22). 
 
Fig:.  2.   R elmed   signa   Hng   pathways  of scleral  remolding in m)-'-opia .  ROS: Re3Ctiv e  oxygen  species;-1flF· la/  P:   Hypoxia-inducible  foctor-J(Vjl;PLC:  ospholipase C; PlP2: 
Phœph.acldy llnosltal bipbos,plia u-: [P3: um rol utphoophaœ; DAG: Dlacylglyc- ol : P KC Pro ceÙl kinase C; AC adenylare cyclase cM tP: Cycllc a<leo odn e monophosphare; TGF-fS: 
Tr.u.lsforming  gr ov1, :hfactor-!};Gp: G-proceln. 
 
 
 
 
Studies noting choroidal changes following  the  induction  of  retinal  defocus  are  ve1y 
nume rous in the literature. However, to the  best  of  our  knowledge,  there does  not  appear 
to be much data in the literature on retinal defocus and its effect on retinal blood flow. The 
2022 study by Swiatczak and associates sought to demonstrate a link between the effect on 
axial length of induced positive defocus and changes in choroidal blood flow, optic nerve 
head and retinal vessels. The results of the study show that myopie defocus induces  a 
decrease in axial length (caused by choroidal thickening) and an increa.se in choroida. l blood 
flow. The results obtained on the con ela.tion between increased a.xia.1 length and decreased 
blood flow to the optic nerve head were not clinica.lly significa.nt. Fina.lly, the a.uthors 
rep01ted no con elation between axial elongation of the eye and a. decrea.se in retinal blood 
flow. However, they did identify an almost significantc01Tela.tion between retinal a.rterio lar 
blood flow and axial length. The effect on a.rterial blood flow , however, was much weaker 
than tha.t observed in the choroid. Their study focused mainly on the short-te1meffects of 
  
  
 
 

8 
 
myopie defocus on changes in blood flow. lt would therefore be possible that a c01Telation 
was not achieved on retinal blood flow due to the too-short period between defocus 
induction and measurement. (23). Indeed, if we assume that a biochemical cascade 
originating in the choroid would release vasoconstrictor mediators to the retina, it could be 
that the onset of their effect is delayed due to the anatomical distance and hematoretinal 
banier of blood vessels in the inner retina. lt is also possible that this effect is different in 
high myopes than in low-to-moderate myopes. The retinal vascular strncture of high myopes 
would be at greater risk of pathological alterations due to their long axial length (23). 
 
lt would therefore be relevant to test the long-term (1 week) effect of positive (myopie) 
defocus, mainly used in myopia cont:rol tec hniques, on the change in retinal vascular 
density. 
 
2) Study objectives 
 
 
Main objective 
 
1. To evaluate retinal blood vessel density measured by Triton OCT-A in myopie 
young adults before and after one week's wear of a peripheral myopie defocus soft 
lens from the Université de Mont:réal study 19_09_27_CERC-19-701P. Compare 
the data obtained with those from one week's wear of a spherical soft daily 
disposable contact lens in the same patients. 
 
 
Secondaiy objective 
 
2. Evaluate choroidal thickness measured by Triton OCT-A in myopie young adults 
before and after one week of wearing a peripheral myopie defocus-inducing soft 
contact lens from the Université de Montréal Study 19_09_27_CERC-19-071P. 
Compare data with one week of spherical soft daily disposable contact lens wear in 
the same patients. 

9 
 
3) Ass umptions 
 
1. Wearing the soft lens for 1 week to induce peripheral myopie defocus will cause an 
increase in blood vessel density measured on OCT-A Triton in young adults. 
Wearing the spherical lens for 1 week to induce peripheral hyperopic defocus will 
cause a decrease in blood vessel density measured with OCT-A Triton in young 
adults. 
 
2. Wearing the soft lens for 1 week to induce peripheral myopie defocus will cause an 
increase in choroidal thickness measured on OCT-A Tli ton in young adults. 
Wearing the spherical lens for 1 week to induce peripheral hyperopic defocus will 
cause a thinning of the choroidal thickness measured with OCT-A Triton in young 
adults. 
 
 
4) Materials and methods 
 
a. Search quote 
 
This study is a crossover trial. 
 
b. Study population, sampling and recruitment procedures 
 
The target population for this study is myopie young adults who meet the following 
criteria: 
 
Inclusion criteria: 
Exclusion criteria : 
• 
Astigmatism :'S 1.00 D 
• 
Myopia between -0.50 and -4.00D 
• 
Recent intake (< 3 months) of 
medication affecting blood pressure 
(e.g. hypotensive, 
anovulant, CNS stimulant, etc.). 
• 
Aged between 18 and 35 
• 
Corneal deform ity 

10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recrnitment will be canied out by posting the research project thumbnail in specific, 
pennitted areas of the Clinique Universitaire de la Vision. Announcements will also be 
placed in Facebook groups made upofoptometiy students, so that students and their friends 
and family can be recrnited. The authors unde1take to ensure the protection of paiticipants' 
personal data by deactivating comments and the option of "tagging" people. The consent 
form will be e-mailed to potential pa1t icipants in advance to allow them to familiarize 
themselves with the reseai·chprocedures, and will be summai·ized dmi ng the first visit to 
ensure free and inf01med decision-making. 
 
•
Hist01y of refractive surge1y 
contact 
defocused 
 
lenses) 
•
Have undergone myop1a control 
treatment during the project or in 
the past (wearing myopically 
defocused glasses or multifocal or 
 
soft contact lenses 
 
•
 
ocular surface 
 

11 
 
 
 
c. Data collection procedure 
 
Data collection will take place during 3 visits to the University Vision Clinic of the 
Université de Montréal located at 3744 Rue Jean-Brillant Suite 110,  Montreal,  QC H3T IPl. 
All participants are advised to abstain from caffeine, tobacco and drngs, and to avoid 
strenuous sports activities. All visits will be scheduled between 12 p.m. and 4 p.m., to avoid 
diurnal variations in choroidal thickness and retinal vessel density. (24). The tests 
perfo1med according to the visit will be as follows: 
 
 
 
Tests 
Visit 1 
Visit 2 
Visit 3 
Case hist01y 
X 
X 
X 
Distancevisual acuity with the patient's 
best c01Tection 
X 
X 
X 
Di stance visual acuity with lenses 
X 
X 
X 
Examination of the anterior segment 
X 
X 
X 
Axial length (anterion) 
X 
X 
X 
Corneal topography (anterion) 
X 
Auto-refraction OPD scan 
X 
Pupil diameter (neuroptic) 
X 
Abenometry without LC (OPD scan) E 
X 
Abenometry with LC OPD scan 
X 
X 
Choroidal thickness (OCT-ATriton) 
X 
X 
X 
Retinal vascular density (OCT-A Triton) 
X 
X 
X 
Lens care and wearing instrnctions 
X 
 
 
First visit 
 
The first visit will begin with a review of the consent fo1m with the pa1ticipant to confüm 
his/her decision to take pait in the study and his/her qualification with regard to the 

12 
 
inclusion/exclusion criteria. A case history will be requested from the patient before testing 
begins (see Appendix 1). The paiticipant's visual acuity will be taken monocularly and 
binocularly with the Snellen cha1t cali brated for 6m, identifying the smallest legible line 
with the patient's best con-ection in order to identify the patient's visual potential. Next, the 
anterior segment is examined using the biomicroscope to identify any ocular surface 
damage that might contraindicate the use of lenses. The eyelids, palpebral conjunctivitis, 
bulbar conjunctiva and comea will be carefully obse1ved under white light. Next, the 
patient's pupilla1y diameter will be measured under photopic conditions in the exainination 
room, using the Neuroptics device. The OPD SCAN III will be used to perform an auto- 
refraction measurement to help select the prescription for the discounted contact lenses, 
and an aben ometrymeasurementwithout the contact lenses in place to visualize the natural 
optical abenations induced by the patient's pupil before the lenses are added. The Anterion 
device will be used to take a baseline measurement of the patient's axial length and to 
perfo1m comeal topography to mie out the possible presence of ectasia in the pa1ticipants. 
Finally, a baseline 6.0mm x 6.0mm measurement of choroidal thickness (um) and blood 
vessel density (%) of the deep and superficial plexus will be analyzed with the OCT-A 
TRITON. 
The patient will receive seven pairs of single-use soft lenses, randomly selected between 
spherical nesofilcon A lenses (Biotrne, Bausch and Lomb) or peripherally myopie defocus 
nesofilcon A lenses (Bausch and Lomb). The order of distribution of the type of lenses 
given at visit 1 and 2 will be dete1mined randomly using the RANDBETWEEN function in 
Excel (see Appendix 4). These lenses are approved by Health Canada, the spherical one 
being marketed in Canada, the other having received authorization for research purposes 
in the project already approved by CERC. The paiticipant will have to wear them for the 
next few days, for 10-12h/day for 6/7 days. Thus, the patient receives 6 pairs of lenses that 
must be wom and an additional pair in case ofbreakage or loss. The patient will be taught 
how to insert, remove and care for the lenses. Visual acuity will be re-measured with the 
contact lenses given to the patient by the research teain. Lens fit will be checked for 
position and movement under a biomicroscope. 

13 
 
Second visit 
 
The second visit will be scheduledone week after the initial visit. It will begin with a case 
history focusing on contact lens wear (see appendices 2 and 3). Visual acuity will be taken 
monocularly and binocularly with the Snellen cha1t cali brated for 6m, identifying the 
smaUest line legible with contact lenses on the eyes. An abenometry measurement with the 
OPD Scan III, with a predetennined pupil size of 5mm, will be taken for each eye with the 
lenses in place, to measure the abenations induced by the presence of the lens on the eye. 
The patient is then asked to remove his or her contact lenses. Measurements of choroidal 
thickness (um) and blood vessel density (%) of the deep and superficial plexus will be taken 
with OCT-A. Axial length will be measured with the Anterion device. Biomicroscopic 
examination of the anterior segment will be perf01med to identi fy any ocular surface 
damage that may have been caused by contact lens wear. 
The patient will receive seven pairs of the second type of lenses to be tested. He will have 
to wear them for the next few days for a period of 10-12h/day and for at least 6/7 days. 
Visual acuity measurements will be taken with the new contact lenses given to the patient 
by the research team. Lens fit will be checked for position and movement using a 
biomicroscope. The patient will be reminded of care and hygiene mles before leaving the 
clinic. 
 
 
 
Third visit 
 
The third visit is scheduled 1 week after the second visit. It will begin with a case hist01y 
focu sing on contact len s wear (see appendix 4). Visual acuity will be measured monocularly 
and binocularly with the Snellen cha1t cali brated for 6m, identifying the smaUest line 
legible with contact lenses on the eyes. An abenometry measurement with the OPD Scan III 
will be taken for each eye with the lenses in place. The patient must then remove the contact 
lenses. Measurements of choroidal thickness (um) and blood vessel density (%) of the deep 
and superficial plexus will be taken with OCT-A. Axial length will be measured with 
theAnterion device. Biomicroscopic examination of the anterior segment 

14 
 
will be perf01med to identify any oculaT smface damage that may have been caused by 
contact lens wear. 
 
 
d. Description of variables 
 
The independent variable in om study is : 
 
Lens type: peripheral myopie defocus (Ll) or spherical(peripheral hyperopic 
defocus) (L2). This is a nominal vaTiable. 
 
 
The dependent variables in om study are : 
 
Percentage density of deep and superficial plexus retinal blood vessels (%) 
analyzed over 3 mm in ETDRS areas (1-5). This is a discrete ordinal variable. 
 
 
Choroidal thickness (um) analyzed over 6 mm in ETDRS areas (1-9). This is a 
discrete ordinal variable. 
 
 
e. Description of lenses used 
 
In this research project, pa11icipants will be fitted with two different 1-day contact lenses, 
both made of Nesofilcon A, a hydrogel material approved by Health Canada. The lens 
tested has a multifocal profile with a central zone A of 2.5mm, 3.2mm or 4.1mm and a 
peripheral zone B with a net addition of +5.00D. The profile chosen will be the same for 
all pa1ticipants, i.e. 4.1mm zone A and a zone B with a +5.00 net addition. This lens has 
been described and is cunently being investigated for its effect on controlling the 
progression of myopia as part of project 19_09_27_CERC-19-071P at the Université de 
Montréal. 

15 
 
The control contact lens is Bausch&Lomb's Biotrue, a single v1s1on spherical daily 
disposable lens with an 8.6mm base cmve. 
 
 
f. Description of measuring instnnnents 
 
Abberometer - OPD SCAN III 
 
 
The OPD scan III is a 5-in-l device for comeal topography, wavefront aben ometly, auto- 
refractometly, keratometly and pupillometly. The OPD Scan can measure pupil sizes up to 
9.5 mm in dian1eter. In our research, the OPD Scan III is used as an autorefractometer and 
wavefront aberrometer (25). Aberrometry will enable us to determine the amount of 
spherical aben ation and "natural" coma aberration generated by the size of the patient's 
pupil. These abe1rntion quantitie s will be compared with those generated by wearing the 
two different types of lenses. 
 
 
Axial length - Anterion 
 
 
The Anterion is a device for measuring comeal topography, tomography and biometly of 
the eye. lt uses swept-source OCT technology, which enables the use of longer wavelengths 
of light for higher image resolution. (26). 
lt will be used at the first visit to perfonn a comeal topography to validate whether the 
patient has a comeal defo1mity that could exclude him or her from the study. Using the 
ectasy analysis, the score value index would be analyzed. If the value is greater than -0.5, 
the patient will be excluded. 
The Anterion would also be used to dete1mine the axial length of participants' eyes . This 
measurementwill be repeated and compared at each of the three visits. In the Cataract APP 
analysis, the value measured in the Axial length section should be taken for each of the two 
eyes. (27). 

16 
 
 
Angiographie optical coherence tomograph (OCT-A) - Triton 
 
 
The TRITON agiographic optical coherence tomograph will be used in this research project. 
OCT-A is a non-invasive angiography that enables changes in retinal vasculruization to be 
obse1ved. This is achieved by analyzing the movement of e1ythrocytes in blood vessels 
using a series ofB-scans (28). The TRITON uses swept-source technology that emits long 
wavelengths, enabling better visualization of the deep vascular layers of the choroid, 
compared with other instrnments that use shorter wavelengths (29, 30). 
This instrnment will be used to visualize choroidal thickness and retinal vascular density at 
the posterior pole. Three scans will be perfonned: OCT-Angiography at the optic nerve head 
(peripapilla1y) 6.0mm x 6.0 mm and at the macula 6.0mm x 6.0 mm for analysis of retinal 
vesse! density, and 3D Macula (H) 6.0mm x 6.0mm for analysis of choroidal thickness in 
the vrufous ETDRS quadrants. These measurements will be taken with the camera's "photo 
flash" switched off, so as not to influence the retina's metabolic functions. Choroidal 
thickness data per quadrant (1-5) will be available in the 6 mm CSI analysis (BM-CSD 
(31). 
 
 
f. Statistical analysis plan 
 
An intragroup three-factor repeated measures ANOVA will be perf01med to analyze the 
change in superficial and deep plexus vascular density and the change in choroidal 
thickness following weru· of the two different lens types. Analysis will be canied out to 
compare changes in each of the ETDRS zones measured at different visits for vascular 
density and choroidal thickness values. A post-hoc analysis using a Bonferonni conection 
will evaluate the differences in variation of these factors for each contact lens studied. 
 
 
g. Sample size jus tification  

17 
 
Sample size was detennined using G*Power software for an intragroup three-factor 
repeated-measures ANOVA. An effect size of 0.3, an alpha en-or of 0.05 and a power of 
0.8 were used. Anumber of21 subjects would be needed to study the variation in vascular 
density of the superficial and deep plexuses and the change in choroidal thickness as a 
function of different soft contact lens optical designs. In this study, a conse1vative sample 
of 25 paiticipants will be used to test the effect of contact lens weai· on changes in retinal 
vascula·i density and choroidalvolume. 
 
 
5) Ethical considerations 
 
The research team undertakes to send each paiticipant a copy of the consent form 
previously approved by the Université de Montréal Health Reseai·chEthics Committee. 
The decision to participate in the reseai·ch project remains voluntary, and no judgment or 
criticism will be expressed in the event of refusal to participate or abandonment of the 
project. The paiticipant may decide to withdraw from the research project at any time. The 
research team also rese1ves the right to exclude a paiticipant who does not meet the 
inclusion criteria or who presents an exclusion criterion. 
Training in lens cai·e and insertion/removal hygiene will be provided at each paiticipant's 
first visit, to mini1nize the risk of infections associated with lens wear. Paiticipants will be 
advised of any side effects that may be associated with lens wear, such as foreign body 
sensation, minimal discomfort or dryness. Patients will also be infmmed of any abnormal 
symptoms to watch out for. The research team is available to respond rapidly to any 
problems encountered by paiticipants, and to monitor their condition closely. 
To protect persona! data, only project members will be able to access the database. Each 
paiiicipant will receive a numerical code linked to their identity. The list linking their 
identity to a numerical code will be kept solely by the principal investigator in a password- 
protected electronic file. This infmmation will be kept in an anonymized database for a 
minimum period of 7 years. 

18 
 
6) Relevance and anticipated benefits 
 
There are ve1y few data in the literature on changes in retinal vascularization following the 
use of a myopie or hyperopic defocus optical design. Choroidal changes are becoming 
better understood, and there is a growing body of data on this subject. The mechanism 
controlling eye elongation still involves a number of unresolved hypotheses. If the results 
of our research suggest an increase in retinal vessel density, this could provide a new avenue 
of research in the field of retinal pathology and myopia control. Such a discove1y could 
strengthen the hypothesis of the possible involvement ofa biochemical message from the 
choroid to the retinal vascular network. This biochemical effect could be used to increase 
retinal vascularization in various retinal pathologies where the vascular system is affected. 
 
 
 
 
 
 
7) Timetable 
 
November 2023: Protocol submitted to research director 
- 
December 2023: Submission of protocol to comse instructor 
April 2024: Ethics committee approval 
May/August 2024: sta1tof paiticipant recrnitment and testing 
August-November 2024: Analysis ofresults 
- 
December-March 2024: Drafting of final rep01t, preparation for scientific day 

19 
 
III. Bibliography 
 
 
1. 
Holden BA, Fricke TR, Wilson DA, Jang M, Naidoo KS, Sankaridurg P, et al. Global 
Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. 
Ophthalmology. 2016;123(5:)1036-42. 
2. 
Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Levezie l N, Mallen EAH, et al. IM I-Onset and 
Progressio n of Myopia in Young Adult s. lnvest Opht halmol Vis Sei. 2023;64(6):2. 
3. 
Flitcro ft Dl, He M, Jonas JB, Jang M, Naidoo K, Ohno-Matsui K, et al. IMI - Defining and 
Classifying Myopia: A Proposed Set of Stan dards for Clinical and Epidem iolog ic Studies. lnvest 
Opht halmo l Vis Sei. 2019;60(3):M 20-m30 . 
4. 
Ku bota R, Joshi NR, Fitzgerald TJ, Samandarova 1, Oliva M, Selenow A, et al. Biometric 
and refractive changes following the monocular application of peripheral myopie defocus using a 
navel augmented-rea lit y opti cal system in adult s. Scientific reports. 2022;12(1):11875. 
5. 
Haarman AEG, Enthove n CA, Tideman JWL, Tedja MS, Verhoeven VJM, Klaver CCW. The 
Complications of Myopia: A Review and M eta-Ana lysis. lnvest Opht halmol Vis Sei. 2020 ;61(4) :49. 
6. 
Agawa T, Miura M, lkuno Y, M a k it a S, Fabritius T, l wasak i T, et al. Choro ida l thickness 
measurement in healthy Japanese  subjects  by  three-dimensional high-penetration  optical 
coherence tomograph y. Graefes Arch Clin Exp Ophthalmol. 2011;249(10):1485-92. 
7. 
Harb E, Hyman L, Gwiazda J, Marsh-Tootle W, Zhang Q, Hou W, et al. Choroidal Thickness 
Profiles in Myopie Eyes of You ng Adults in the Correction of Myopia Evaluati on Trial Cohort . Am J 
Opht halmo l. 2015;160(1):62-71e2. 
8. 
Hashimoto S, Yasuda M, Fujiwara K,Ueda E, Hata J, Hirakawa Y, et al. Association 
between Axial Length and Myopie Maculopathy: The HisayamaStudy. Opht halmol Reti na . 
2019 ; 3(10 ):867-73. 
9. 
Flitcroft Dl. The complex interactions of retinal, opti cal and environmenta l factors in 
myopia aetiology. Progress in Retinal and Eye Research. 2012;31(6):622-60 . 
10. 
Nguyen KH, Patel BC, Tadi P. Anatomy, Head and Neck: Eye Reti na . StatPearls. Treasure 
Island (FL)2023 . 
11. 
Tro ilo D, Smith EL, 3rd, Nickla DL, Ashby R, Tkatchenko AV, Ostrin LA, et al. IMI - Report 
on Experimental Models of Emmetropization and Myopia. lnvest Ophthalmol Vis Sei. 
2019 ; 60(3) :M 31-M88. 
12. 
Frank RN, Amin RH, Eliott D, Puklin JE, Abrams GW. Basic fibroblast growth factor and 
vascular endot helia l growth factor are present in epiretinal and choroidal neovascular 
membranes. Am J Ophthalmol. 1996;122(3):393-403. 
13. 
Ostrin LA, Harb E, Nickla DL, Read SA, Alonso-Cane iro D, Schroed l F, et al. IMI-The 
Dynamic Choroid: New lnsights, Challenges, and Potenti al Significance for Human Myopia. lnvest 
Opht halmo l Vis Sei. 2023;64(6):4. 
14. 
Chiang STH, Phillips JR, Backhouse S. Effect of reti nal image defocus on the thickness of 
the human choroid. Ophthalmic & physiological optics: the  journal of  the  British College of 
Opht halmic Opticians (Optometrists). 2015;35(4):405-13. 
15. 
Wang D, Chun RKM, Liu M, Lee RPK, Sun Y, Zhang T, et al. Optical Defocus Rapid ly 
Changes Choroidal Thicknessin Schoo lchildren. PloS one. 2016;11(8):e0161535. 
16. 
Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, lshiko S, et al. Effect of spectacle 
lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese 
children : a 2-year multi center randomized cont ro ll ed t ria l. Jpn J Ophthalmol. 2018;62(5):537-43. 

20 
 
17 
Chen Z, Xue F, Zhou J, Qu X, Zhou X. Effects of Orthokeratology on Choroidal Thickness 
and Axial Length. Optomet ry and vision science: offi cial publication of the American Academy of 
Optometry. 2016;93(9):1064-71. 
18 
Breher K, Garcia Garcia M, Ohlendorf A, Wahl S. The effect of the optical design of 
multifocal contact lenses on choro idal t hicknes s. PloS one. 2018;13(11):e0207637. 
19. 
Campbell JP, Zhang M, Hwang TS, Bailey ST, W il son DJ, Jia Y, Huang D. Detailed Vascular 
Anatomy of the  Human Retina by Projection-Resolved Optical Coherence  Tomography 
Angiography. Sei Rep. 2017;7 :42201. 
20. 
Cano J, Rahimi M, Xu BY, Richter GM, Tan 0 , Huang D, Shahid i M. Relationship Between 
Macular Vessel Density and Total Retin al Blood Flow in Primar y Open-angle Glaucoma.J 
G laucom a. 2021;30(8):666-71. 
21. 
Francisco B-M, Salvador M, Amparo N. Oxidative Stress in M yopia . Oxidati ve Medicine 
and Cell ular Longevit y. 2015;2015 :750637 . 
22. 
Yang J, Ouyang X, Fu H, Hou X, Liu Y, Xie Y, et al. Advances in biomed ical study of the 
myopia-related signaling pat hways and mechanisms. Biomed Pharmacot her. 2022;145:112472. 
23. 
Swiatczak B, Schaeffel F, Calzetti G. lmposed positi ve defocus changes choro idal blood 
flow in younghuman subjects. Graefe's archive for clinical and experimental opht halmo logy = 
Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2023; 261(1):115- 
25. 
24. 
Williams RC, Harrison WW, Carkeet A, Ostrin LA. Tw ent y-fo ur hour diurnal variati on in 
retinal oxygen saturation. Vision Res. 2023 ; 213:10831 4. 
25. 
Nidek. Refractive Pow er / Corneal Analyzer OPD-Scan Ill [07-11-2023] . Available from : 
htt ps:// w ww.nidek-int l.com/ product/ ophthaloptom/ diagnostic/ dia_cornea/ opd-scan3.html. 
26. 
Asam JS, Polzer M, Tafreshi A, Hirn schall N, Findl O. Anterior Segment OCT. ln: Bille JF, 
editor . High Reso luti on lmag ing in M icros copy and Ophthalmology: New Frontiers in Biomedical 
Optics. Cham (CH): Springer 
Copyright 2019, The Author(s). 2019. p. 285-99. 
27. 
Engineering H. Anterion [07-11-2023]. Available from: https:// business- 
lounge.heide lbergengineering .com/ gb/ en/ products / anterion / anterion / #product-detai ls. 
28. 
de Carlo TE, Romano A, Waheed NK, Duker JS. A re view of opti cal coherence tomograph y 
angiography (OCTA). lnt J Retina Vit reous. 2015;1 :5. 
29. 
Khorrami-Nejad M, Khoda ir AM, Khodaparast M, Babapour Mofrad F, Dehghanian 
Nasrabadi F. Comparison of the ocular ult rasonicand opti cal biometry devices in the different 
qualit y measurements. J Optom . 2023;16(4):284-95. 
30. 
Wang E, Zhao X, Yang J, Chen Y. Visualizati on of deep choroidal vasculatures and 
measurement of choroidal vascular density: a swept-source optical coherence tomograph y 
angiography appro ach. BMC Opht halmo logy. 2020;20(1):321. 
31. 
Topcon Corporation. User Manual - # D Optical Tomography - DRI OCT-1 Made l Triton 
[PDF].Tokyo, Japan2025. Available fr om : htt ps:// ww w.topcon .ca/ wp- 
content/ uploads/ 2016/ 12/ DRI-OCT-1-M ode l-Triton_ Triton-p lus-1n st rument- M anuai.pdf. 

21 
 
IV. Appendix 1 
Table 2. Case history oriented visit 1 
 
yes no 
Are you taking any medication? If yes, please specify : 
Have you ever been diagnosed with a comeal deformity? 
Do you smoke (including vaping)? 
Do you cmTently have myopia control treatment or have you had it in the 
past? 
Are you pregnant or breast-feeding? 
Have you had refractive surgery in the past? 
Have you consumed caffeine, tobacco, alcohol or done strenuous exercise 
in the last 24 hours? 
Have you wom soft LCs in the past? 
 
 
 
 
V. Appe ndix 2 
 
 
Tab le 3: Case history oriented visit 2 and 3 
 
yes I no 
Have you consumed caffeine, tobacco or alcohol in the last 24 hours? 
- 
days 
In the past week, how many days did you wear the LCs given to you by 
the research team? 
- 
h 
During the past week, for how many hours on average did you wear the 
LCs given to you by the research team? 

22 
 
VI. Appendix 3 
 
 
 
Questionnaire lenses Visit 2-3 Tried pair 
Participant code  
Date  
_ 
What time do you insert your lenses in the moming? 
 
 
What time do you remove your contact lenses in the evening? 
 
 
 
 
 
PLEASE MARK EACH OF THE FOLLOWING ITEMS WITH THE 
NUMBER THAT BEST DESCRIBES YOUR LENS EXPERIENCE. 
SCALE (1-10): 0: very bad./ always 10: excellent / never 
 
 
QlA. Quality of vision (DAY) 
from a distance (TV, cinema, etc.) 0 1 2 3 4 5 6 7 8 9 10 
intermediate(computer) 0 1 2 3 4 5 6 7 8 9 10 
near (reading, telephone) 0 1 2 3 4 5 6 7 8 9 10 
 
Q lB. Quality of vision (NIGHT) 
from a distance (TV, cinema, etc.) 0 1 2 3 4 5 6 7 8 9 10 
intermediate(computer) 0 1 2 3 4 5 6 7 8 9 10 
near (reading, telephone) 0 1 2 3 4 5 6 7 8 9 10 
 
Q2A. Perception of ghost images (glare) - DAY 
fu 
012345678910 
intermediate(computer) 0 1 2 3 4 5 6 7 8 9 10 
near (reading, telephone) 0 1 2 3 4 5 6 7 8 9 10 
 
Q2B. Perception of ghost images (glare) - NIGHT 
far 
012345678910 
intermediate(computer) 0 1 2 3 4 5 6 7 8 9 10 
near (reading, telephone) 0 1 2 3 4 5 6 7 8 9 10 

23 
 
Q 3A . Vision remains stable (DAY) 0 1 2 3 4 5 6 7 8 9 10 
 
Q3B. Vision remains stable (NIGHT) 0 1 2 3 4 5 6 7 8 9 10 
 
Q4A.Vision in driving, bicycle(DAY) 0 1 2 3 4 5 6 7 8 9 10 
 
Q4b. Driving vision, bicycle(NIGHT) 0 1 2 3 4 5 6 7 8 9 10 
 
Q5. Perception of halos in the evening 0 1 2 3 4 5 6 7 8 9 10 
 
Q6 General satisfaction - vision 0 1 2 3 4 5 6 7 8 9 10 
 
Q7. General satisfaction - comfort 0 1 2 3 4 5 6 7 8 9 10 
 
VII. Appendix 4 
Table showing randomization of lens wear for participants between visit 1 and 2 
 
 
Parti cipant 1st 
wk 
2nd 
wk 
Parti cipant 1st 
wk 
2nd 
wk 
Parti cipan t 1st 
wk 
2nd 
wk 
1 
s 
B 
10 
s 
B 
19 
s 
B 
2 
s 
B 
11 
s 
B 
20 
s 
B 
3 
B 
s 
12 
B 
s 
21 
B 
s 
4 
B 
s 
13 
B 
s 
22 
B 
s 
5 
s 
B 
14 
B 
s 
23 
s 
B 
6 
B 
s 
15 
s 
B 
24 
B 
s 
7 
s 
B 
16 
B 
s 
25 
B 
s 
8 
s 
B 
17 
s 
B 
9 
B 
s 
18 
B 
s 
 
S : Single vi sion lens 
B : Bi focal high-add lens 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 1 on 6 
 
Université rH, 
de   Montréal 
 
 
 
Title of research project : 
Information and consent form 
 
Effect of Defocus in Soft Contact Lenses on Internai Retinal 
Vascularization 
 
Researcher in charge of the project 
and Research Director: 
 
 
 
 
Co-investigator 
 
 
 
 
 
 
Co-investigator(s) : 
Student(s): 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research project funding : 
Dr. Langis Michaud, optometrist, MS 
Full Professor 
School of optometry 
University of Montreal 
Telephone: (514) 343-6111 ext. 8945 
E-mail: langis.michaud@umontreal.ca 
 
Dr. Rémy Marcotte-Collard, optometrist, MS 
Clinical lectu r er 
School of optometry 
University of Montreal 
Telephone: (514) 343-6082 
E-mail: remy.marcotte.2@umontreal.ca 
 
Catherine Forest 
Candidate for Doctor of Optometry, 1st cycle 
School of optometry 
University of Montreal 
Telephone: (514) 343-6082 
E-mail: cathe rine.forest@umontr eal.ca 
 
Oleksandra Pysarenko 
Candidate for Doctor of Opt ometry , 1st cycle 
School of optometry 
University of Montreal 
Telephone: (514) 343-6082 
E-mail: oleksandra.pysarenko@umontreal.ca 
 
The lenses used in this project are supplied by Bausch and 
Lomb. 
 
 
1. Introduction 
 
We invite you to participate in a research project. However, before agreeing to participate in this project and signing 
this information and consent form, please take the time to read, understand and carefully consider the following 
information. 
 
This form may contain words you do not understand. We invite you to ask any questions you may have to the 
researcher in charge of this project or a member of the research team, and to ask them to explain any words or 
information that is not clear. 
 
2. Nature and objectives of the research project 
 
As it develops, myopia causes the eye to lengthen, which in turn can lead to pathologiessuch as ret inal detachment 
and glaucoma. In recent years, researchers and manufacturers have developed spectacle lenses or contact lenses 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 2 on 6 
 
with a special design that slows the progression of myopia. They are therefore prescribed to myopie children whose 
vision defect is progressing, in order to avoid these long-term complications. 
 
The present study, in which you are invit ed to take part, aims to recruit a population of adults. It is a known fact that 
40% of young adults with myopia continue to develop. Few optical means are available to them. Participant s will be 
required to wear a high addit ion bifocal lens. Measurements will be t aken before and after wearing the lens. 
 
The present study is therefore being carried out to check whether the effects of t his lens, similar to the one tested 
on younger patients, will be comparable. 
 
In this study, we will measure short -term changes in ret inal blood vessels to determine whether the lens worn has 
an effect that promotes myopie contrai (increased vessel density ) or no effect (reducedvessel densit y). These results 
will help predict whether this type of lenscould represent a valid option for controlling myopia in young adults. 
 
To carry out this research project, we plan to recruit around 25 participants (M and F) , aged between 18 and 35. 
 
3. Conducting the research project 
 
3.1 Research project location, duration and number of visits 
 
This research project will take place at the Clinique Universitaire de la Vision. Your part icipation in this project will 
last 2h30 and will include 3 visits spaced one week apart . These visits will ta ke place in the afternoon, at roughly the 
same time each time . 
 
3.2 Nature of your participation 
 
By participating in this research project, you will carry out the following activit ies, procedures and tests : 
 
Visit 1 
Visit 2 
Visit 3 
Schedule 
T=O 
T+l 
week 
T+ 2 weeks 
Duration (min) 
60 
45 
45 
Case history 
At the 1st visit, the researcher will check that all the criteria allowing you 
to take part in the study have been met. On visits 2 and 3, the researcher 
will ask how things have gone, and whether anything new has corne to 
light. 
X 
X 
X 
Distance visual acuity with the patient's best correction 
You'll need to identify the smallest line of letters you can see, at a 
distance, while wearing your glasses or contact lenses. 
X 
X 
X 
Anterior segment eye health examination 
At each visit, an examination of the smface of the eye (conjunctiva - 
white of the eye and cornea - transparent pait in front of the eye color) 
will be perfo1med to ensure that the eye is healthy and can be tested. 
Fluorescein staining test: a drop of a yellow dye, called fluorescein, will 
be placed on the surface of your eyes. This test is used to assess dty eyes 
and comeal abrasion or scratches. 
X 
X 
X 
Optical coherence tomography (OCT-anterior) measurement 
OCT is a device that scans the superficial layers of the eye (cornea, 
anterior chamber, c1ystalline lens). 
X 
X 
X 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 3 on 6 
 
Dynamic refraction and aberrometry 
This device automatically measures your refractive error (refraction) by 
scanning a light target in the eye (dynamic). It also measures the 
dispersion of this light in the eye (aben ometry ). 
X 
(without 
lenses) 
X 
(with 
lens es) 
X 
(with 
lenses) 
Pupil diameter 
The size of the pupil (black pait of the eye) is measured with a device 
(pupillometer- like a camera). 
X 
Optical coherence tomography (posterior OCT) measurement 
OCT is a device that scans the deep layers of the retina (back of the eye) 
X 
X 
X 
Recommendaitons 
During visits 1 and 2, you will be given instmctions on how to wear and 
care for your contact lenses. 
X 
X 
 
4 Participant cooperation 
 
Before att ending the test days, you must not have consumed caffeine, tobacco, drugs or exercised with in the last 12 
hours. 
 
S. I ncidental discovery 
 
Alt hough not subject to formai optomeric evaluation, since this is a research project, the result s of all the tests, 
examinations and procedures carried out as part of this research project may reveal hitherto unknown problems - a 
so-called chance discovery. This is what we call a chance discovery. That' s why, in the event of a peculiarit y, the 
researcher in charge of the project will inform you to ensure follow-up. 
 
6. Benefi ts associa ted with the research project 
 
You may der ive some persona! benefit from your participation in this research project, but we cannot assure you of 
t his. On the other hand, the results obtained will contribute to the advancement of scient ific knowledge in this field 
of research. 
 
7. Disadvant ages associated with the research project 
 
The only disadvantages associated with this project are the t ime and t ravel involved. 
 
S. Risks associated with the research project 
 
The associated risks concern contact lens wear. I n this study, single-use (1-day) contact lenses were used. This is 
the wearing modality associated with the lowest complication rate. However, some participants may experience one 
or more of the following symptoms. These symptoms are rare with single-use lenses. 
 
- pain 
- foreign body sensation in t he eye 
- dry eye during wear 
- redness of the white of the eye (conjunctiva) 
- abnormal secretions of tears or mucus (a beige deposit on the edge of the eyelids, which stretches when removed) 
- allergies to any of the mater ials or solutions in the lens packaging 
- reduced vision (in case of inflammat ion or infect ion) 
Light sensitivity in some tests performed 
If necessary, a break will be taken to help you recover. I f you agree, the tests will be resumed at a time of your 
choosing. 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 4 on 6 
 
Risks associat ed with fluorescein : 
 
The dye may be detectable in breast milk, so it  is recommended that breast-feeding mothers wait 8 to 12 hours 
after the tests before feedingthe baby. 
 
 
9. Voluntary part icipation and right of wit hdraw al 
 
Your part icipation in t his research project is voluntary. You are therefore free to refuse to take part. You may also 
withdraw from t his project at any t ime, without giving any reason, by informing the research team. 
 
Your decision not to part icipate or to withdraw from this research project will not affect the quality of care and 
services, present or future, to which you are ent it led at the Universit y Vision Clinic. 
 
The researcher responsible for t his research project or the Clinical Research Ethics Committ ee may te rminate your 
part icipation without your consent . This can happen if new findings or information indicate that your participation in 
the project is no longer in your best interest, if you fail to comply with the researchproject' s inst ructions, or if t here 
are administrat ive reasonsfor abandoning t he proj ect. 
 
I f you withdraw or are withdrawn from the project, the information and material already collected as part of the 
project will neverthelessbe retained, analyzed or used to ensure the int egrit y of the project. 
 
Any new knowledge acquired during the course of the project that could have an impact on your decision to continue 
part icipating in this project will be communicated to you promptly. 
 
10. Privacy 
 
During your part icipation in this research project, the researcher in charge of this project and the members of the 
research team will collect, in a research file, the information concerning you and necessary to meet the scientific 
objectives of this research project. 
 
This may include information about your past and present health and lifest yle, as well as your answers to 
questionnaires and the results of all act ivities, tests, examinat ions and procedures that will be performed. Your fil e 
may also include ot her informat ion such as your name, gender, date of birth and ethnie origin. 
 
Ali informat ion collected will remain confidential. To preserveyour identity and the confidentiality of this information, 
you will be identified only by a code number. The code key linking your name to  your research  file will  be kept  by t 
he researcher responsible for this research project. 
 
This research data will be kept for at least 7 years by the researcher responsible for this research project. 
Research data may be published or discussed in scientific meetings, but it will not be possible to identify you. 
For surveillance, cont rol, prot ectio n and security purposes, your research file may be consulted by a person mandated 
by t he Universit é de Montréal or the Clinical Research Et hics Committee. These individua ls and organizations adhere 
to a confidentiality policy. 
 
You have the rig ht to consult your researchfile to verify the information collected and have it corrected if necessary. 
 
11. Part icipati on in furt her studies 
 
Do you agree that the researcher in charge of t his research project, or a member of his or her research staff, may 
contact you again to propose that you participate in other research projects approved by the Clinical Research Ethics 
Comm itt ee of the Université de Montréal? Of course, at the t ime of contact, you will be free to accept or refuse to 
participatein the proposed research projects. □ Y es o  No 
12. Seco nd a ry u se of re sea rch dat a 
 
Do you agree that your research data may be used by the responsible researcher to carry out other research projects 
in the field of optometry? 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 5 on 6 
 
These research projects will be evaluated and approved by the Clinical Research Et hics Committee before they are 
carried out. The Committee will aise ensure follow-up. Your research data will be stored securely on Université de 
Montré al computer servers. To preserve your identity and the confidentiality of your research data, you will be 
identified only by a code number, and measures will be taken to keep this information confidential. 
 
Your research data will be kept for as long as it is useful for t he advancement of scient ific knowledge. When it is no 
longer useful, your research data will be destroyed. Please note that you may request that your research data not 
be used at any time by contacting the researcher in charge of the research project. 
 
Do you agree to your research data being used under these conditions? □ Yes 
□ No 
 
13. Marketing potential 
 
Research result s resulting from your participation could lead to the creation of commercial products and generate 
profits. However, you will not benefit financially. 
 
14. CompensatioB 
 
You will not receive any financial compensation for your participation in this research project. 
 
15. In the event of loss 
 
Should you suffer any harm whatsoever as a result of your part icipatio n in the research pro ject, you will receive all 
the care and services required by your state of health. 
 
By agreeing to participate in this research project, you do not waive any of your rights and you do not release the 
researcher responsible for this research project , and the Université de Mont réal from their civil and professional 
liabilit y. 
 
16. Medical emergency procedures 
 
Please note that the Université de Mont réal does not offer emergencyservices. Therefore, in the event of a medical 
condit ion requiring immediate attention, first aid will be provided by the staff on hand and arrangementswill be made 
to transfer you, if necessary, to a nearby hospital emergency room. 
 
17. Reporting general results 
 
The results obtained from this research project could be present ed as a poster at a scient ific day organized by the 
Université de Montréal School of Optometry. They could also be presented at conferences or in the form of a scientific 
article. 
 
 
18. Contacts 
 
I f you have any questions about the research project or if you wish to withdraw from the research project, you can 
contact the researcher in charge of this research project at the following coordinates: Dr Langis Michaud Optom etrist, 
MS. École d'optomé t rie de l'U de M. 3744 Jean-Brilla nt, suite 6462. Montreal H3T 1P1. Tel : 514 -343 - 6111 ext. 8945. 
E-mail : langis.m ichaud@umo nt re al. ca 
 
Complaints concerning this research may be addressed to the Université de Montréal Ombudsman at ( 514) 343- 2100 
or ombudsman@umontre al.ca. The ombudsman accepts collect calls. He speaks English and French and takes calls 
between 9 a.m. and 5 p.m. 
 
19. Monitoring the ethical aspects of the research project 
 
The Clinical Research Ethics Committee of the Université de Montréal has approved the research project and will 
ensure its follow-up. 

I nformat ion and consent for m appro ved on April 09, 2024 by the Clinical Research Ethics Committ ee. 
CERC-2024-51 33 Part icipan t of legal age - 
Page 6 on 6 
 
Consent . 
 
Title of research project : 
Effect of myopie and hyperopic peripheral defocus in soft contact lenses on 
inner retinal vascularization 
 
1. Participant consent 
 
I have read the information and consent form. The research project and this information and consent form have been 
explained to me. My questions have been answered and I have been given sufficient time to make a decision. After 
careful consideration, I consent to participate in this research project under the conditions stated herein. 
 
 
Name and signature  of part icipant 
Date 
 
 
2. Signature of the person who obtained the consent, if different from the researcher responsible for 
the research project 
 
I explained the researchproject and this information and consent form to the part icipant and answered any questions 
he asked. 
 
 
Name and signature of persan obtaining consent 
Date 
 
3. Signature and commitment of the researcher responsible for this research project 
 
I certify that t his information and consent form has been explained to the participant and that any questions have 
been answered. 
 
I  undertake, together with the  research team , to respect  what has been agreed in the informat ion and consent form. 
 
 
Name and signature of the researcher responsible for this research project 
Date