One-year Efficacy and Tolerance of Myofix Spectacles for the Control of Myopia Progression
Phase: NA
Conditions: Myopia Progression
Sponsor: Novar Corporation

1 
 
 
Buenos Aires, March 4th, 2023 
 
 
Research Project for the Control of Myopia Progression  
using Peripheral Defocus Glasses (MYOFIX STUDY) 
 
Sociedad Argentina de Oftalmología 
Ethics Committee. 
 
Dear Dr. Marcelo Zas. 
 
We are writing to request that you kindly consider the ethical aspects of the following 
research study in clinical ophthalmology aimed at halting the progression of myopia with 
special myopia control glasses, as referred to in this request. 
 
Dr. Rafael Iribarren 
Dr. Abel Szeps 
 
 
 
 
 
 
 

2 
 
MYOPIA CONTROL STUDY 
 
Study on the Tolerance and Efficacy of the Use of Peripheral Defocus Spectacles for 
the Control of Myopia Progression in Children and Adolescents. 
 
PRINCIPAL INVESTIGATOR. Dr. Rafael Iribarren 
ASSOCIATE INVESTIGATORS. Drs. Abel Szeps, Carlos Kotlik, Liliana Laurencio, 
Sebastián Dankert, Alejandro Armesto, Leonardo Fernández Irigaray, 
RESEARCH CENTER. Office Dres. Iribarren. Arenales 981. CABA. 
 
TYPE OF STUDY 
 
A longitudinal, prospective, interventional, clinical ophthalmology research study to 
evaluate the tolerability and efficacy of intervention with the use of a nationally designed 
eyeglass to control the progression of myopia in childhood and adolescence. 
 
PROBLEM STATEMENT JUSTIFYING THE STUDY 
 
Refractive errors are considered the second leading cause of visual impairment 
worldwide.1 Global estimates indicate that approximately 312 million in 2015 are short-
sighted, figure that could rise to 324 million by 20251 and a 4,758 million for  2050.2,3 
Geographically, the distribution of myopia in the world varies significantly,4 with figures 
ranging from 6.1% for Morocco (Africa) up to 96.5% for Korea, (Asia).3,5,6 Ethnic contrast 
and lifestyle habits in Asian and African populations are potential associated factors, 
although such a claim remains to be fully elucidated.3 

3 
 
 
In East Asia, the prevalence of myopia reaches 80%,7,8 in Europe is lower, at 47.2% for the 
group between 25 and 29 years of age for the year 2015.9 In Latin American populations 
such as Brazil, the prevalence in the adult population was of 29.7% for the year 2009.10 In 
the United States, there is evidence of a disproportionate increase in the number of 
myopes, with a prevalence of between 25 and 41.6% between the ages of 12 and 54 years 
for the year 2011.11 
 
In the report of the countries that make up the Ibero-American Epidemiological Network 
for Eye and Eye Health, for the period 2009-2010, the lowest prevalence for children was 
reported in Argentina (1.2%) and the highest in Ecuador with 25.2%. The low values in 
Argentina were determined only in rural areas and this is why they are so contrasting with 
the rest of the countries in the network. Another study from Argentina conducted in office 
workers in the city of Buenos Aires has found a prevalence of myopia of approximately an 
25%.12 In Colombia, the diagnosis of myopia in the 2009-2010 period was 21% and 22%, 
respectively, with a higher prevalence in the 5 to 14 years age group, followed by the 15 to 
44 years age group.13 
Myopia progression can trigger pathologic changes in the eyeball that affect structures 
such as the lens, retina, choroid and macula. Myopia progression doubles the risk of 
nuclear cataract,14 open-angle glaucoma,15 maculopathy, choroidal neovascularization and 
retinal detachment.16 These degenerative changes are the most frequent cause of vision loss 
with irreversible blindness.17 and are associated with refractive values of more than 5-6 
diopters of myopia in adult life. 6,18-21 
Research work on preventive treatments, to date, is generally conducted on children 6-12 
years of age,22,23 and a few unpublished studies of natural history or treatment effectivity in 

4 
 
adolescents are ongoing. In addition, children who begin with their myopia between the 
ages of 5 and 7 years of age when they do not yet read intensely, they often have genetic 
myopia that may develop high myopia.24 In turn, these children are the ones most at risk 
for adult disability due to myopic maculopathy.17 It has been suggested that these children 
should be treated according to the myopia consensus of the SAOI Myopia Study Group 
with atropine 0.01% or 0.05% to prevent such rapid progression.25 Children over 8 years of 
age progress at a slower rate, even more slowly as they get older.26 
In recent years, several treatments have been developed to halt the progression of myopia 
at school age, among which the daily instillation of 0.01% atropine drops stands out for its 
efficacy.27 Despite the high dilution, there are reservations among pediatric ophthalmogists 
about the toxic effect that a daily instilled drop could have from elementary school age to 
25 - 30 years of age, and therefore there is interest in developing other less invasive 
therapeutic methods.27 In this regard, the different types of spectacles and peripheral 
defocus contact lenses have recently shown good effectiveness in several randomized and 
controlled clinical trials against the natural history of progression.28 In some cases these 
studies have been ongoing for 5 years and have shown similar effectiveness to atropine 
(60% reduction in progression) as presented at the last International Myopia Conference in 
Rotterdam last month. Studies combining both therapeutics are already underway with 
modest results of an increase in effectiveness to 70% reduction of progression (presented at 
the same Conference). These peripheral defocus lenses and peripheral contrast decreasing 
lenses could replace formal glasses in the case of myopic children, since formal glasses 
could favor the progression of myopia since they produce peripheral hyperopic defocus.29 
Studies in monkeys from 2005 by Earl Smith III showed that the area surrounding the 
fovea was in control of eye growth, as compensation of the imposed lenses occurred 
equally even with the laser ablated fovea.30 Thus, attention began to be paid to where the 

5 
 
images fell in the mid-periphery and was tested on animals and humans with positive 
addition multizone defocus lenses that place part of the image plane in front of the retina, 
thus slowing down ocular growth.31 Since 2011, several studies have been presented 
showing how myopia slows down its progression with the adaptation of multizone defocus 
contact lenses with positive additions in the periphery. 31 There are even multifocal glasses 
for myopia control such as Essilor's Varilux for more than 20 years, which follow the same 
principle although they are not as effective (20% effect) and therefore have not been 
widely used.32  
Currently there are several patented commercial brands that offer (in Asia and Europe) 
multizone defocus lenses with positive defocus in the periphery to stop the progression of 
myopia. None of them is still on sale in our country, but CooperVision's Proclear 
multifocal contact lenses, designed to treat presbyopia in adults, of which there is a variety 
with a center for distance (like the lenses tested for myopia) are sometimes accessible in 
our environment with the difficulty that the population of opticians and ophthalmologists 
are mostly unaware of their possible use and do not recommend them. These same lenses 
were used “off-label” in a clinical study in 2013 in England showing modest results with a 
40% decrease in progression.33  
CURRENT STATE OF RESEARCH 
At the aforementioned International Conference a month ago, Mark Bullimore34 and other 
researchers pointed out that it has become a problem to conduct randomized controlled 
studies against natural history because it is unethical to leave them to their own devices 
when off-label treatment with 0.01% atropine has already been accepted in various 
consensuses.25,28,35,36 This diluted drug has already been approved in Singapore, Japan and 
India where it exists in commercial form, but in other countries it is only available as a 

6 
 
compounded formula. 
 
Thus, at the Conference, several investigators showed that ongoing studies with a natural 
history control group see their number of cases decrease with follow-up as patients drop 
out to seek medical care to prevent myopic progression with the means available today. 
These means are dilute atropine drops, daily outdoor exposure,34 reading with inverted 
contrast,35 special contact lenses for myopia control, peripheral defocus glasses and 
contrast reduction glasses, both designed for myopia control. In our environment, only the 
first three are available to the population. That is, we can recommend more outdoor 
exposure, reading with inverted contrast (not yet tested in a randomized study) or instilling 
diluted atropine drops off-label.  
Due to the problem of attrition in the control group, it has been suggested in the last 
International Myopia Conference that controlled field studies be performed by a virtual 
group, without performing a non-inferiority study, since atropine 0.01% could not be taken 
as gold standard because it is not yet approved and as we said, it is off-label in Argentina. 
Data on progression in Asia or Europe could be used for this virtual control group, but it 
would be more convenient to have a virtual control group in one's own living environment. 
In the case of our country there is already a possible control group of 114 children of 12 
years of age on average who were followed up with cycloplegia during the years pre-
pandemic and from which it is known that the progression was from 0.43+/-0.52 diopters 
in one year.36  
It is thus proposed to perform a prospective clinical study in 100 children who will be 
enrolled when in the usual consultation for their eyeglasses control they can choose to do 
the treatment accessible in our environment (the diluted atropine drop) or a treatment that 
is possibly equally effective with special glasses designed in our environment. It is 

7 
 
expected that there will be similarity of effect on progression because the lens is based on 
the principles of defocusing of eyeglasses and contact lenses already proven by the 
international industry.37 Our lens has the characteristic of being much simpler in its carving 
and construction, making it more economical for our environment where it has already 
been presented from the theoretical point of view.38  
Moreover, the special myopia control spectacle lacks the possible toxic effects of a drop 
instilled in the eye for many years until emerging adulthood. In addition, to avoid including 
children who may have rapid progressions to high myopia, treatment will be offered only 
to children over 8 years of age. In our environment, where children are outdoors a lot, the 
progression is slower than in Asian countries and is around -0.50 diopters per year, as we 
said.36 A strong myopia is the one that exceeds -5.00 diopters.39 Thus the risk for a child 
included in this project is to progress -0.25 diopters in six months (the resolution limit of 
the measurement method), so each child who does not respond well with arrest of 
progression at six months may be removed from the protocol and switched to atropine 
treatment. 
Given the above-mentioned background, the following study has been designed to evaluate 
the arrest of myopia progression with the daily use of nationally designed glasses, 
comparing such progression with a virtual control group of similar age in a population of 
myopic children and adolescents of the same environment in our country. 
 
WORKING HYPOTHESIS 
 
The nationally designed lenses can be as effective as the proven international industry 
designs that have been subjected to controlled trials against natural history of the disease. 
 

8 
 
 
 
PURPOSE 
To treat a group of consecutive volunteer patients who choose between the affordable 
treatment in our environment (daily diluted atropine drops for several years) or the special 
lenses for myopia control designed by the National Industry. The purpose is to compare the 
progression during one year with the national lenses with respect to the progression with 
the foreign lenses and/or with the natural history of a virtual control group. 
 
 
OBJECTIVES 
Primary 
To assess whether the intervention with locally designed spectacles is well tolerated and 
adhered to with daily use in childhood and adolescence. 
Secondarily 
To assess whether intervention with locally designed glasses can control myopia 
progression in childhood and adolescence. 
 
DEFOCUS GLASSES OF NATIONAL DESIGN 
 
The design of the national defocus lens is based on the original design presented by Carly 
Lam,40 with a 9 mm central zone for distance correction and a correction ring with a +3.50 
dioptre defocus between 9 and 32 mm in diameter to act in principle on the para foveal 
zone which is the one that detects the defocus that governs the growth of the eye.41 Instead 
of peripheral defocusing micro lenses that do not alter the visual field in the area of the 32 

9 
 
mm diameter ring with the treatment,40 the national design that was presented has a 
uniform +3.50 diopter power zone that alters the visual field by 5% at 10 degrees from the 
circular shaped fovea,38 as presented at the International Myopia Conference a month ago. 
As it is known that positive defocus in 30-40 minutes of exposure modifies the axillary 
length (measured with Lenstar) by 10 microns due to changes in the choroidal thickness,42 
The national design has been tested on 17 volunteer subjects showing a significant change 
of 11 microns in the axial length of their eyes, suggesting this pilot study (in the process of 
being published) that the lenses should be effective in halting the progression of myopia, as 
changes in the choroid are the first event in the retinal message that governs ocular 
growth.43 This, coupled with the survey that gave a good reading tolerance in 70% of the 
17 respondents within a month of wearing them, was presented at the Conference and is in 
the public domain. Respondents found it difficult to walk around with these lenses because 
they are like an executive bifocal, but tolerated them well for reading at home, with small 
lateral movements of the head when reading A4 texts or the computer. It is therefore our 
intention to do a free field test with such lenses on a larger sample. 
 
POPULATION 
Consecutive patients between 8 and 16 years of age who attend the institutions accredited 
for this study. These institutions will be accredited only if they can perform routine studies 
for myopia control (refraction exam and optical biometry). 
 
USE OF GLASSES 
 
Once the eyeglass prescription has been written by the ophthalmologist, the enrolled 
patients will be seen in opticians accredited for this study in close proximity to the 

10 
 
ophthalmology offices that are members of the research team. The opticians and 
ophthalmologists will be asked to watch a video on myopia control developed by the 
principal investigators where this treatment methodology is explained during the 
evaluation process at the center of care. The opticians will verify the optical centration in 
the frames chosen ad hoc, with a modern digital centration system provided by the 
sponsors. After 15 days, when the glasses with the correct centering are ready, the subjects 
will go to the optician's office to try on the glasses in that room. On this occasion, as 
always in these cases, the optician will evaluate the subject's adaptation and mobility in the 
optician's shop, instructing the child to wear the glasses at home for a couple of days and 
then to wear them for as long as possible. 
 
SAMPLE AND SAMPLE SIZE 
 
The sample size will be 50 subjects of both genders to compare with the studies abroad that 
consist of an n between 40 and 90 subjects and the natural history in our country that 
counted 114 subjects. There will be a group of subjects who will be treated with the 
nationally designed defocus glasses. Statistical calculation for a difference of 0.25 diopters 
in progression with respect to controls, for a standard deviation of 0.50 diopters gives an n 
= 31 subjects and taking into account a 20% loss to follow-up the n should equal 38 
subjects 
in 
the 
group. 
Thus 
reaching 
50 
subjects 
exceeds 
expectations. 
 
METHODS 
 
This field study to test tolerance and percentage of effectiveness of defocus lenses in the 
control of myopia will include boys and girls from 8 to 15 years of age who voluntarily 

11 
 
agree to take the test for one year, with no ocular pathology other than myopia, with 
spherical equivalent (sphere + 50% of the cylinder) between -0. 50 D and -5.00 D, with 
astigmatism less than -2.00 D in each eye, with anisometropia less than -1.00 D, with 
keratometry less than 47.00 D in the most curved meridian. Genetic syndromes will not be 
included or ruled out. A complete ophthalmologic evaluation will be performed including 
tonometry, fundus, subjective refraction and refraction under cycloplegia with two drops of 
1% cyclopentolate instilled 5' apart and performed 40' after the last drop. Visual acuities of 
the subjective refraction will be greater than 8/10 in each eye. Axillary length 
measurements with optical biometry will be performed at the beginning of treatment at 
follow-up and at the end of the study. New cycloplegic refractions will be performed 
during follow-up and at one year of treatment. A survey of habits and history, including 
reading, outdoors, ON-OFF contrast use, hours of schooling, age of onset of spectacle use 
and family history of high myopia (also likely use of devices to monitor these habits in 
selected group) will be conducted. A pair of spectacles and their frames will be provided 
free of charge to all children studied for one year with the special addendum of peripheral 
defocus treatment or laser treatment for contrast reduction depending on the treated group. 
The children will be instructed to wear the glasses especially in front of smartphones, 
tablets, PC's or books at home after five o'clock in the afternoon and until going to bed, 
every day of the week including Saturdays and Sundays. During the rest of the day they 
will use their usual correction without properly updated defocus. As defocus in 
experimental animals has more effect in stopping experimental myopia in the afternoon 
than in the morning,44 It is expected that use in the afternoon only will be sufficient to 
achieve the effect. On the other hand, the peripheral contrast-lowering lens that has shown 
good tolerance and absence of visual field alteration will be used all day long by the 
subjects under treatment. 

12 
 
 
All the data of affiliation, contact telephone number, date of birth, refraction under 
cycloplegia, axillary length and questionnaire will be entered in a centralized digital 
history by NOVAR developers. These data will be kept confidential. During follow-up 
visits, accredited professionals throughout the country will have access to upload the data 
required for each visit. One month after the eyeglasses are delivered, the professional will 
conduct a telephone survey to parents to evaluate adherence. The first stage of the study 
will be completed after one year and the child will be able to continue with the treatment 
for myopia control according to the consensus guidelines on myopia treatment of the 
Myopia Study Group of the SAOI (Annex I). For virtual control group, data will be taken 
from 114 children followed with cycloplegia by the pandemic study group during the years 
2018-2019 that showed for an average age of 12 years an annual pre-pandemic progression 
of -0.45 D. In the present study, We expect to evaluate the progression with peripheral 
defocus treatment over one year of an equivalent group of children. 
 
WORK PLANNING / GANTT CHART: 
 
Activity 
1
2-4
5-24
25
26
27
28
Project Design 
Bibliographic search 
Ethics Committee Presentation 
Data collection 
Data analysis 
Preliminary results 
Final Results 
Report writing 
X
X
X 
 
X 
X 
 
X 
X 
 
X 
 
X
 
X
X 
X 
 
X
X
TIME IN MONTHS 

13 
 
INCLUSION / EXCLUSION CRITERIA 
 
All consecutive patients of both genders who freely opt for lenses of national industry will 
be included in the present study. All patients who present any systemic or ocular pathology 
that may affect their refraction measurements or their evolution will be excluded from the 
study. Also excluded from the protocol in the follow-up will be those patients who, even 
using defocus glasses, had in 6 months an improvement equal to that expected without any 
intervention. These patients will be treated with other options available in our environment 
at the time of the change. The computerized medical records system will be configured to 
detect such patients at the time of loading the follow-up data and will send an alert to the 
investigators. 
EVALUATION OF TOLERANCE AND ADHERENCE 
Adherence will be evaluated at the one-year follow-up and will be reported as the number 
of cases that failed to complete the three scheduled visits in one year with respect to the 
total number of cases that were enrolled in compliance with the first visit and the delivery 
of the spectacle. Tolerance of these glasses will be assessed with a tolerance questionnaire 
that is presented in the attached medical record. This questionnaire has already been tested 
on 24 subjects aged 18 to 24 years in a pilot trial presented at the International Myopia 
Conference, as explained in the previous section on the defocus spectacle, showing good 
tolerance in these subjects. Some tests in younger children that were performed in the last 
months show that tolerance is very good in them, since minors have greater plasticity and 
adaptability than young adults previously tested. Tolerance and adherence will be 
classified as GOOD / BAD, in a dichotomous way, with the cut-off according to the 
answer given by whether the child tolerated them well or not. On the other hand, tolerance 
will also be evaluated in dichotomous form with responses to reading and walking 

14 
 
performance. 
 
PROCEDURES TO GUARANTEE ETHICAL ASPECTS 
The anonymity of all participants will be preserved. Patients' names will be removed from 
the database for statistical analysis. The only ones who will know the names of the patients 
are the physicians involved in their primary care, and they will have to keep the 
information in their respective institutional medical records and enter the data necessary 
for the research in a web form designed by the sponsoring company. 
The Declaration of Helsinki and its modifications, the Good Clinical Practices guide, the 
harmonization norms and the resolution of the Ministry of Health 1480/11 will be observed 
and taken into account as guidelines (See informed consent ANNEX VI). It is stated for the 
record that the principal investigator does not have any type of conflict of interest since the 
patenting of the defocus glasses is the responsibility of the sponsor's company. 
 
SAFETY PRECAUTIONS 
One month after the delivery of the spectacle, the principal investigator in charge will 
make a telephone call to the parent of the study subject conducting the tolerance survey 
and thus verifying adherence to spectacle use. The survey is detailed in the attached 
medical record and responses will be uploaded into the computerised web-based system 
that will be developed for this study. The system will automate the alerts for these safety 
calls with automatic emails sent to the principal investigator in the month of spectacle 
delivery. 
 
 

15 
 
PLAN FOR ANALYSING THE RESULTS 
 
The results of numerical variables shall be expressed as mean and standard deviation or 
median and interquartile range according to whether they are normally or skewed. Nominal 
variables will be expressed as absolute frequency and percentage. For the comparison of 
numerical variables, Student's t-test or Mann Whitney U-test will be used as appropriate. 
Nominal variables will be compared using the Chi-square test or Fisher's exact test as 
appropriate. A p-value of p ≤ 0,05.  
 
HUMAN RESOURCES 
 
Dr. Abel Szeps and Dr. Rafael Iribarren are in charge of the design and control of the 
research. Statistical analysis will be performed by Dr. Rafael Iribarren. Physicians 
accredited to treat patients will have to demonstrate the ability to perform routine 
consultations for myopia control, refraction studies under cycloplegia and optical biometry. 
Once accredited, they will have a username and password to upload their data into the web 
form. Accredited doctors will be in permanent communication with doctors Abel Szeps 
and Rafael Iribarren. There will be a myopia progression monitoring system within the 
computerised system that will send reports if any child progresses more than 0.25 dioptres 
in six months to alert researchers so that precautionary measures can be taken in such 
cases. 
 
 
 
 

16 
 
MATERIAL RESOURCES 
Optotypes, Retinoscope, Autorefractometer and Biometer posters of accredited institutions. 
Approximately four institutions with a high turnover of paediatric consultations are 
expected to be accredited for an estimated enrolment time of 6 months. 
Peripheral defocus spectacles will be provided by the sponsor (NOVAR) free of charge to 
all study subjects for one calendar year with the possibility of extending the study for two 
years. At the end of the study, if the expected positive results are found, the glasses will 
remain in the possession of the study subjects. 
 
FINANCIAL RESOURCES  
 
It is considered necessary for the development of the study the free coverage by the 
sponsors (NOVAR) of the peripheral defocus glasses. Money will also be spent for the 
web form system programmers and for the two ophthalmologists in charge of the study. 
The expenses of the medical consultations made by the subjects at the time of enrollment 
and follow-up will be paid by the medical system of each of the accredited institutions 
(whether these are social security or prepaid health insurance of the subjects) since no 
more consultations are required for the study than the three per year recommended for 
myopia control according to the last consensus of the Myopia Study Group of the SAOI 
(Annexed). No corneal or eyeball complications are expected (as with contact lenses or 
drops) since the glasses are a prosthesis that is not introduced into the body and acts at a 
distance. 
 
 

17 
 
CENTERS OF ATTENTION 
 
Eight enrollment centers will be chosen. To avoid biases in the methodology and to adjust 
the feasibility of developing a joint protocol, training interviews will be conducted with the 
investigators from each center in a timely manner. The principal investigator will maintain 
weekly communication by telephone with each of the investigators involved in each center.  
 
ENROLLMENT 
Consecutive patients attending the above-mentioned care centres for glasses prescription 
will be enrolled. Family members will be informed in writing and verbally of the 
objectives of the study and will sign an informed consent for the study. 
Subjects must be willing to participate in a study lasting 1(one) year (it will be explained to 
them at the beginning of the study that the free treatment materials will in principle only 
extend for that period). 
 
Risks, discomforts or ethical issues related to participation: 
 
Clinical and biometric ophthalmological studies with or without cycloplegia are routine 
and free of discomfort for patients. 
CRITERIA FOR INCLUSION  
 Patients of both sexes aged between 8 and 16 years, without ocular pathology added 
to myopia. 

18 
 
 Myopia ranges between 2.00 D and 5.00 D in both eyes. 
 Refractive astigmatism less than one diopter in each eye. 
 Visual acuity 20/25 or better in both eyes. 
 
 
 
 
EXCLUSION AND ELIMINATION CRITERIA 
 
Patients who do not meet the aforementioned inclusion criteria. 
Patients with poor adherence to treatment demonstrated by poor compliance with follow-
up interviews. 
Patients whose family members do not sign the informed consent form. 
 
Drs. Rafael Iribarren and Abel Szeps. 
 
 
 
 
 
 
 
 
 
 

19 
 
REFERENCES. 
 
1. 
Rudnicka AR, Kapetanakis VV, Wathern AK, Logan NS, Gilmartin B, Whincup 
PH, Cook DG, Owen CG. Global variations and time trends in the prevalence of 
childhood myopia, a systematic review and quantitative meta-analysis: implications 
for aetiology and early prevention. Br J Ophthalmol 2016; 100: 882-90. 
2. 
Bruce A. Re: Holden et al.: Global prevalence of myopia and high myopia and 
temporal trends from 2000 through 2050 (Ophthalmology 2016;123:1036-1042). 
Ophthalmology 2017; 124: e24-e5. 
3. 
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong 
TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia 
and Temporal Trends from 2000 through 2050. Ophthalmology 2016; 123: 1036-
42. 
4. 
Morgan IG, Rose K. Yunnan Minority Eye Study Suggests That Ethnic Differences 
in Myopia Are Due to Different Environmental Exposures. Investigative 
ophthalmology & visual science 2015; 56: 4430. 
5. 
Kim EC, Morgan IG, Kakizaki H, Kang S, Jee D. Prevalence and risk factors for 
refractive errors: Korean National Health and Nutrition Examination Survey 2008-
2011. PloS one 2013; 8: e80361. 
6. 
Dolgin E. The myopia boom. Nature 2015; 519: 276-8. 
7. 
Chassine T, Villain M, Hamel CP, Daien V. How can we prevent myopia 
progression? European journal of ophthalmology 2015; 25: 280-5. 
8. 
Morgan IG, Rose KA. Myopia: is the nature-nurture debate finally over? Clinical & 
experimental optometry 2019; 102: 3-17. 
9. 
Williams KM, Verhoeven VJ, Cumberland P, Bertelsen G, Wolfram C, Buitendijk 
GH, Hofman A, van Duijn CM, Vingerling JR, Kuijpers RW, Hohn R, Mirshahi A, 
Khawaja AP, Luben RN, Erke MG, von Hanno T, Mahroo O, Hogg R, Gieger C, 
Cougnard-Gregoire A, Anastasopoulos E, Bron A, Dartigues JF, Korobelnik JF, 
Creuzot-Garcher C, Topouzis F, Delcourt C, Rahi J, Meitinger T, Fletcher A, 
Foster PJ, Pfeiffer N, Klaver CC, Hammond CJ. Prevalence of refractive error in 
Europe: the European Eye Epidemiology (E(3)) Consortium. European journal of 
epidemiology 2015; 30: 305-15. 
10. 
Schellini SA, Durkin SR, Hoyama E, Hirai F, Cordeiro R, Casson RJ, Selva D, 
Padovani CR. Prevalence of refractive errors in a Brazilian population: the 
Botucatu eye study. Ophthalmic epidemiology 2009; 16: 90-7. 
11. 
Vitale S, Ellwein L, Cotch MF, Ferris FL, 3rd, Sperduto R. Prevalence of refractive 
error in the United States, 1999-2004. Arch Ophthalmol 2008; 126: 1111-9. 
12. 
Cortinez MF, Chiappe JP, Iribarren R. Prevalence of refractive errors in a 
population of office-workers in Buenos Aires, Argentina. Ophthalmic Epidemiol 
2008; 15: 10-6. 
13. 
Brusi L. AL, Alberdi A. Informe de la salud visual y ocular de los países que 
conforman la Red Epidemiológica Iberoamericana para la Salud Visual y Ocular 
(REISVO). 2015. 
14. 
Pan CW, Cheng CY, Saw SM, Wang JJ, Wong TY. Myopia and age-related 
cataract: a systematic review and meta-analysis. American journal of 
ophthalmology 2013; 156: 1021-33 e1. 

20 
 
15. 
Marcus MW, de Vries MM, Junoy Montolio FG, Jansonius NM. Myopia as a risk 
factor for open-angle glaucoma: a systematic review and meta-analysis. 
Ophthalmology 2011; 118: 1989-94 e2. 
16. 
Faria-Ribeiro M, Queiros A, Lopes-Ferreira D, Jorge J, Gonzalez-Meijome JM. 
Peripheral refraction and retinal contour in stable and progressive myopia. 
Optometry and vision science : official publication of the American Academy of 
Optometry 2013; 90: 9-15. 
17. 
Franco PJ, Suwezda A, Schlottmann P, Destefanis MP, Rosenstein RE, Iribarren R, 
Grzybowski A. Analysis of visual disability in Buenos Aires, Argentina. Pathologic 
myopia is the leading cause in working age. Medicina 2021; 81: 735-41. 
18. 
Verkicharla PK, Ohno-Matsui K, Saw SM. Current and predicted demographics of 
high myopia and an update of its associated pathological changes. Ophthalmic 
Physiol Opt 2015; 35: 465-75. 
19. 
Saw SM. How blinding is pathological myopia? The British journal of 
ophthalmology 2006; 90: 525-6. 
20. 
Saw SM, Gazzard G, Shih-Yen EC, Chua WH. Myopia and associated pathological 
complications. Ophthalmic Physiol Opt 2005; 25: 381-91. 
21. 
Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet 2012; 379: 1739-48. 
22. 
Lee SSY, Mackey DA, Lingham G, Crewe JM, Richards MD, Chen FK, Charng J, 
Ng F, Flitcroft I, Loughman JJ, Azuara-Blanco A, Logan NS, Hammond CJ, Chia 
A, Truong TT, Clark A. Western Australia Atropine for the Treatment of Myopia 
(WA-ATOM) study: Rationale, methodology and participant baseline 
characteristics. Clin Exp Ophthalmol 2020; 48: 569-79. 
23. 
Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of 
Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology 2016; 
123: 391-9. 
24. 
Magnetto I MO, Magnetto A, Torres RM, Iribarren R. Low prevalence of myopia 
in children from a rural population in Marcos Juarez, Argentina. Oftalmologia 
Clinica y Experimental 2021; in press. 
25. 
Galan MM SA, Fernandez Irigaray L, Rodriguez G, Aguirre R, Kotlik C, Iribarren 
R. Consenso de Miopia. Oftalmologia Clinica y Experimental 2022. 
26. 
Sankaridurg PR, Holden BA. Practical applications to modify and control the 
development of ametropia. Eye (Lond) 2014; 28: 134-41. 
27. 
Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, 
Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia 
Institute: Interventions for Controlling Myopia Onset and Progression Report. 
Investigative ophthalmology & visual science 2019; 60: M106-M31. 
28. 
Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, 
Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, 
Smith EL, 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. 
IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci 2021; 62: 
6. 
29. 
Charman WN, Radhakrishnan H. Peripheral refraction and the development of 
refractive error: a review. Ophthalmic Physiol Opt 2010; 30: 321-38. 
30. 
Smith EL, 3rd, Ramamirtham R, Qiao-Grider Y, Hung LF, Huang J, Kee CS, Coats 
D, Paysse E. Effects of foveal ablation on emmetropization and form-deprivation 
myopia. Investigative ophthalmology & visual science 2007; 48: 3914-22. 
31. 
Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia 
progression in children. Ophthalmology 2011; 118: 1152-61. 

21 
 
32. 
Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, 
Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle 
lenses slow myopia progression: a 2-year randomised clinical trial. The British 
journal of ophthalmology 2019. 
33. 
Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens 
myopia control. Optometry and vision science : official publication of the American 
Academy of Optometry 2013; 90: 1207-14. 
34. 
He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. 
Effect of Time Spent Outdoors at School on the Development of Myopia Among 
Children in China: A Randomized Clinical Trial. Jama 2015; 314: 1142-8. 
35. 
Aleman AC, Wang M, Schaeffel F. Reading and Myopia: Contrast Polarity 
Matters. Scientific reports 2018; 8: 10840. 
36. 
Picotti C SV, Fernandez Irigaray L, Morgan IG, Iribarren R. Myopia Progression in 
Children during COVID-19 Home Confinement in Argentina. Oftalmologia Clinica 
y Experimental 2021; in press. 
37. 
Jones L, Drobe B, Gonzalez-Meijome JM, Gray L, Kratzer T, Newman S, Nichols 
JJ, Ohlendorf A, Ramdass S, Santodomingo-Rubido J, Schmid KL, Tan D, Tan 
KO, Vera-Diaz FA, Wong YL, Gifford KL, Resnikoff S. IMI - Industry Guidelines 
and Ethical Considerations for Myopia Control Report. Invest Ophthalmol Vis Sci 
2019; 60: M161-M83. 
38. 
Martín De Tomas CK, Abel Szeps, Ricardo Impagliazzo, Rafael Iribarren. Nuevos 
anteojos para control de la miopía. Oftalmologia Clinica y Experimental 2022; 15: 
240. 
39. 
Ohno-Matsui K, Wu PC, Yamashiro K, Vutipongsatorn K, Fang Y, Cheung CMG, 
Lai TYY, Ikuno Y, Cohen SY, Gaudric A, Jonas JB. IMI Pathologic Myopia. 
Invest Ophthalmol Vis Sci 2021; 62: 5. 
40. 
Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, 
Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle 
lenses slow myopia progression: a 2-year randomised clinical trial. Br J 
Ophthalmol 2020; 104: 363-8. 
41. 
Panorgias A, Aigbe S, Jeong E, Otero C, Bex PJ, Vera-Diaz FA. Retinal Responses 
to Simulated Optical Blur Using a Novel Dead Leaves ERG Stimulus. Invest 
Ophthalmol Vis Sci 2021; 62: 1. 
42. 
Read SA, Alonso-Caneiro D, Vincent SJ, Collins MJ. Longitudinal changes in 
choroidal thickness and eye growth in childhood. Invest Ophthalmol Vis Sci 2015; 
56: 3103-12. 
43. 
Wallman J, Winawer J. Homeostasis of eye growth and the question of myopia. 
Neuron 2004; 43: 447-68. 
44. 
Nickla DL, Thai P, Zanzerkia Trahan R, Totonelly K. Myopic defocus in the 
evening is more effective at inhibiting eye growth than defocus in the morning: 
Effects on rhythms in axial length and choroid thickness in chicks. Experimental 
eye research 2017; 154: 104-15. 
 
 
 
 
 

22 
 
PROTOCOL V 1.2 - MARCH 2023 
 
NAME and SURNAME ........................ .............................. ...................... 
DNI........................... ........................  
 
 
CELL PHONE........................ .............................. ................ 
EMAIL........................... .............................. .............................. ... 
DATE OF BIRTH ........................ ....... ...... BOY GIRL 
 
PART I 
DATE OF FIRST VISIT ........................ .......................... 
SPHERICAL RIGHT EYE ..................CYLINDRICAL ....... ............. AXIS............. .........  
LEFT EYE SPHERICAL................ ....CYLINDRICAL .....................AXIS ............. .........  
AXIAL LENGTH OD.................. ...... OI..................... ......... 
 
K1 OD........................... K2 OD .............................. .  
K1 OI........................... K2 OI .............................. ... 
 
MOM HAS HIGH MYOPIA OR NOT 
DAD HAS HIGH MYOPIA OR NOT 
AGE OF FIRST EYEGLASSES PRESCRIPTION ......... ...................... 
HALF DAY SCHOOL SCHEDULE OR WHOLE DAY 
HOUSE WITH GARDEN OR APARTMENT 
LOOK WITH INVERTED CONTRAST ON CELL PHONE OR COMPUTER? YES NO 
 
 
 
 
 
 
 
ON ANY DAY YOUR CHILD GOES TO SCHOOL ..... 
(If he/she goes to school by car or bus, leave the next question blank) 
If he/she walks or rides a bike to school, how many minutes does it take him/her to get 
there?.............Min. 
 
Do you take tutoring outside of school? (Circle) YES NO 
How many hours do you spend outdoors when you leave school? .....................Hs 
How many hours per day do you spend reading books or doing homework? 
.....................Hs 
How much time per day do you spend playing with your cell phone or tablet? .... 
..................Hs 
ON ANY SATURDAY OR SUNDAY....... 
How many hours per day do you spend reading books or doing homework? ..................Hs 
How many hours per day do you spend outdoors on a weekend day? ...................Hs 
How much time per day do you spend playing with your cell phone or tablet? 
...................Hs 
 
PART II EYEGLASS DELIVERY 
DATE ............................................. 
 

23 
 
PART II. BIS (ATTACHMENT QUESTIONNAIRE) 
AT THE MONTH OF DEFOCUS EYEWEAR DELIVERY (TELEPHONE SURVEY) 
DATE .......................................... 
Have you worn the glasses at home during this month?  
YES NO 
Have you worn glasses all day this month? YES NO 
If you answered “YES” to any of the above, continue with these ..... 
 
In general, do you tolerate them well? 
YES NO 
Have you ever had trouble turning your head to look sideways?   
YES NO 
Out of the seven days of the week, how many days do you not use 
them?..................................  
Have you ever had trouble turning your head to look down when reading? YES NO 
Have you ever had trouble turning your head to look down when walking? YES NO 
 
PART III 
DATE SECOND VISIT AFTER SIX MONTHS.................................................. 
EYE DER SPHERICAL ..................CILINDRICAL .................... AXIS......................  
SPHERIC IZQ EYE....................CILINDRITRIC ..................... AXIS......................  
AXIAL LENGTH OD........................ OI.............................. 
PART III (BIS) SIX MONTH ADHERENCE QUESTIONNAIRE 
Have you worn your glasses at home during this month?   
 
YES NO 
Have you worn glasses all day during this month?  
 
YES NO 
If you answered "YES" to any of the above continue with these..... 
In general, do you tolerate them well? 
 
 
 
 
 
 
YES NO 
Have you found it difficult to turn your head to look sideways?  
 
YES NO 
Of the seven days of the week, how many days do you not use them? .............................. 
Did you have trouble turning your head to look down when reading? 
 
YES NO 
Have you had trouble turning your head to look down when walking?  
 
YES NO 
 
PART IV 
DATE THIRD VISIT AT TWELVE MONTHS............................................ 
RIGHT EYE SPHERICAL ..................CILINDRICAL .................... AXIS......................  
LEFT EYE SPHERICAL....................CYLINDRICAL .....................AXIS......................  
AXIAL LENGTH OD........................ OI.............................. 
 

24 
 
INFORMED CONSENT 
 
 
 
STUDY ON TOLERANCE AND EFFICACY  
OF GLASSES “MYOPIA CONTROL” 
CONSENT FORM 
 
(Study on the Tolerance and Efficacy of the Use of Peripheral Defocus Spectacles  
for the Control of Myopia Progression in Children and Adolescents). 
 
PROTOCOL NUMBER:………………………………………………….. 
PRINCIPAL INVESTIGATOR. Dr. Rafael Iribarren 
RESEARCH CENTER. Office Dres. Iribarren. Arenales 981. CABA. 
OPHTHALMOLOGY OFFICE 
 
PHONE 54911-5147-9312 
 
EMAIL : rafairibarren@gmail.com 
 
 
This consent form may contain words that you do not understand, so please ask the 
investigator or person responsible for the study to clarify any words or questions you have. 
You have the right to a copy of this consent form to think about your participation in this 
study or to discuss it with family and friends before making a decision. 
 
The purpose of this document is to help you make an informed decision on whether or not 
to participate in the study entitled TOLERANCE AND EFFICACY OF WEARING EYE 
EYES FOR MYOPIA CONTROL (CONTROL MYOPIA) with/without funding. 
 
 
I.- INTRODUCTION: 
 
 
Your child has been invited to participate in a research study. However, before you or your 
child agrees to participate in the CONTROL MIOPIA study. 
 
Before you decide to participate in the study, read this form carefully and ask any 
questions you may have, to ensure that you understand the study procedures, risks 

25 
 
and benefits, so that you can decide voluntarily whether or not you wish to 
participate. If after reading this document you have any doubts, ask the responsible 
investigator or study staff to explain them to you, feel free to ask about any aspect 
that helps you to clarify your doubts. They should provide you with all the 
information you need to understand the study. 
 
Once you have understood the study and if you wish to participate, then you will be asked 
to sign this consent form, of which you will receive a signed and dated copy. 
 
II.- PURPOSE OF THE STUDY 
 
The main reason for participating in this study is to try to slow the annual progression of 
myopia in children using a specially designed myopia control eyeglass. 
  
 
III. JUSTIFICATION FOR THE STUDY. 
 
This myopia control is justified to prevent your child from progressing to high values of 
myopic correction in the eyeglasses, since these high values generate a higher percentage 
of disability in adulthood. 
 
IV. OBJECTIVE OF THE STUDY 
 
You are being invited to participate in a research study that aims to slow down the 
progression of myopia in children year by year, with the result that they will have to 
change their glasses for higher magnification over time. The aim of this study is to measure 
the tolerance to ‘myopia control’ designer glasses and to confirm their effectiveness. 
 
V.- STUDY PARTICIPANTS: 
 
5.1.- Children aged 8 to 15 years with confirmed myopia without other ocular or general 
diseases will be included. 
 
5.2.- Forty children of both genders will participate in this study. 
 
VI.- STUDY PROCEDURES:  
 
6.1.- What will be done in this study? In this study, the usual ophthalmologic examination 
will be performed with the prescription of glasses for daily life as every year, and a free 
eyeglass with a special design “myopia control” will be made for the child to use it at will 
most of the time to test its tolerance and effectiveness. 
 
6.2. What research procedures will I participate in if I decide to enter the study? 
The only research procedure implemented will be the use of the “myopia control” glasses 
in daily life. 
 
6.3.- The aim is to investigate whether this myopia control spectacle is tolerated for 
reading, playing with the tablet, watching television, talking, eating and walking, that is, in 
all activities of daily life. In addition, with the annual control of the prescription it will be 
seen if the “myopia control” glasses stop the progression of myopia. 

26 
 
 
6.4.- This project has a duration of one calendar year. 
 
6.5.- This includes visits every six months as is routine in cases of myopia. 
 
VII. STUDY BENEFITS 
 
The benefit of participating in this study is to be able to make a treatment that controls the 
progression of myopia. There is already the alternative of using diluted atropine drops off-
label and this treatment has been applied in our environment for several years. There have 
also been trials with myopia control glasses and contact lenses in Asia and Europe with 
good results. The advantage of using myopia control glasses instead of diluted atropine 
drops is that the latter are more invasive and may have long-term toxic effects. Myopia 
control glasses have no toxic or undesirable effects. The myopia control contact lenses 
recently approved in the USA are not yet available in our country and have more 
undesirable effects such as possible eye infections associated with the use of contact 
lenses. Therefore, myopia control glasses seem to be the best option. This study does not 
include compensations and the myopia control glasses with their respective frames and 
their replacement in case of breakage during the year of the trial will be provided free of 
charge. 
 
 
VIII. RISKS ASSOCIATED WITH THE STUDY  
 
In the judgment of the researchers, the study does not involve any physical or 
psychological risk to you. Your answers will not cause you any risk or consequences of 
any nature. You will participate in the usual consultations for the prescription of lenses, 
will make the necessary studies for the ocular examination and will answer periodic 
surveys about the tolerance to the use of the myopia control glasses. There are no known 
undesirable effects from the use of these glasses in previous studies. Should you develop 
any adverse side effects or require other care, it will be provided on the terms that have 
always been offered. If the child has any type of discomfort, the doctor should be informed 
as soon as possible in order to reach a diagnosis and receive the appropriate treatment. The 
expected benefit of this treatment is to slow down, in part, the progression of progressive 
myopia, thus achieving that the final increase that the person will have in his adult life will 
be the smallest possible. It is not expected that the eyeglasses will decrease during the 
treatment, but simply that the problem will not advance so much. If this happens, it is 
possible that the child will not have to change the magnification of his glasses every year. 
 
 
IX.-  BENEFITS 
 
You may not receive any personal benefit from participating in this study. 
 
Your myopia may stop completely or progress slowly rather than as expected as a result of 
your participation in this study, however, there is no guarantee that this will occur. 
 
This study has the benefit of producing scientific knowledge for the community of 
ophthalmologists and opticians seeking to control myopia, and the research findings could 

27 
 
contribute to science for better treatment for the future of this disease, which is the leading 
cause of visual impairment in the working age. 
 
This study does not contemplate direct benefits for the guest. 
 
 
X.- TIME: 
 
How long will it take me to participate in this study? This study does not involve more 
time than the time necessary for regular ophthalmologic care and the visit to the optician 
for the provision of glasses for myopia, with subsequent control every six months.  
 
 
When will my participation end? Participation will end at the end of one year of wearing 
the “myopia control” glasses, after which the participant may choose to continue wearing 
them or switch to the myopia control methods that are available at that time, as the outlook 
in this regard is changing. In total the participant will make three office visits and three 
visits to the optician who will provide the glasses. 
 
 
VII- COSTS  
 
There are no additional costs to participate in this study since the visits are the usual ones 
provided by the health systems for ophthalmologic control and the myopia control glasses 
will be delivered and replaced free of charge. 
 
 
X.- CONFIDENTIALITY AND STORAGE OF INFORMATION 
 
 
 
Your identity will be protected. All information and/or data that can identify the 
participant will be handled confidentially, taking security measures in which your 
computerized medical history will only be visible to the treating physician and the 
principal investigators. Only Rafael Iribarren and Abel Szeps will have access to data that 
can identify a participant (directly or indirectly), the members of the research team. We 
will not disclose any information from you or provided by you during the research. When 
the results of the research are published or discussed at scientific conferences, information 
that could reveal your identity will not be included. Any disclosure of information obtained 
will be for scientific and/or educational purposes. 
 
Specify data management for each activity, the form of registration and 
confidentiality, for example: Each participant will have a unique computerized record to 
which only the treating physician will have access and who will have a unique username 
and password. In this way only the acting professional will have access to the subject's 
information. This information will be automatically dumped into an anonymized Excel 
table for statistical study. The statistical study will be in charge of the principal investigator 
(Rafael Iribarren). Each treating physician will keep the identity of the participants under 
his/her care confidential. 
 

28 
 
 
XI.- VOLUNTEERS 
 
Your participation in this study is completely voluntary. You may decide whether or not to 
participate in this project; your decision whether or not to participate in this project will not 
affect the care you may continue to receive (or your current or future relationship with 
your treating physician and the research team). 
You may withdraw from the research at any time, without penalty or loss of benefits to 
which you would be entitled; withdrawing is of no consequence to you.  
You may request information related to the research project at any time from the 
Responsible Investigator, Sr Rafael Iribarren, Phone +54911-5147-9312, Email 
rafairibarren@gmail.com 
 
 
XIII.- QUESTIONS/INFORMATION:  
 
You have the right to clarify any doubts you may have, you may request more detailed 
information about the research or any topic related to the study, at any time you wish, you 
should contact the principal investigator. Dr. Rafael Iribarren, Phone +54911-5147-9312 
 
If you consider that there are no doubts or questions about your participation, you may, if 
you wish, sign the Letter of Informed Consent that is part of this document. 
 
When changes occur in the conditions or procedures of a study and also in long-term 
studies, the responsible investigator must renew the Consent. 
 
XV. ETHICAL COMMITTEE 
 
The Committee is a group of people independent of the study, which evaluates the 
compliance with national and international ethical regulations and ensures the protection of 
the rights, safety and welfare of the human beings involved in a research. 
 
 
With the purpose of watching over the faithful fulfillment of the Informed Consent, it is 
possible that you may be contacted by a member of the Committee to carry out a brief 
interview or survey, in person, by telephone or electronically. The investigator responsible 
for the study will be aware of the communication between you and the Committee. You 
may refuse to participate in the survey without affecting your participation in the study. 
 
This study was approved by the Research Ethics Committee of the Argentine Society 
of Ophthalmology (CEISAO). The main mission of the Ethics Committee is to protect 
the people who participate in the research. If you have any doubts or questions about 
any aspect of this study DO NOT hesitate to contact us, as well as you can report any 
event. You may, if you wish, make your inquiry anonymously, and your decision will 
be respected. You may be contacted by a CEISAO member to evaluate how the study 
is developing. You can contact us by e-mail: ceisociedadoftalmologia@gmail.com 
and/or by cell phone (11) 62074223 from 10 am to 4 pm, Monday to Friday. 

29 
 
 
 
XVI. RIGHTS OF PARTICIPANTS 
 
I have read, understood and discussed the above information with the investigator 
responsible for the study and my questions have been answered to my satisfaction.  
 
My participation in this study is voluntary; I may withdraw from participation at any time, 
without cause and without liability.  
 
If, during the course of the research, information relevant to my continued participation in 
the study becomes available, the investigator must provide this information. 
 
I have been informed and understand that the data obtained in the study may be published 
or disseminated for scientific and/or educational purposes.  
 
If during the course of the research I have questions about the research or my participation 
in the study, I can contact the responsible investigator, Sr Rafael Iribarren, Phone +54911-
5147-9312, Email rafairibarren@gmail.com 
 
 
I agree that my child (NAME AND LAST NAME) ....................................................... may 
participate in this research study entitled “Myopia Control.” I will receive a signed and 
dated copy of this consent form.  
 
 
 
 
_____________________________________ _____________________  
Mother/Guardian Signature 
 
 
_____________________________________ 
Date 
 
 
_____________________________________ 
DNI 
 
 
 
_____________________________________ _____________________  
Signature of parent / guardian 
 
 
_____________________________________ 
Date 
 
 
_____________________________________ 

30 
 
DNI 
 
 
 
_____________________________________ _____________________  
Witness (optional in case of vulnerability of the child / a) 
 
 
____________________________________ 
Date 
 
 
____________________________________ 
DNI 
 
 
 
____________________________________ _____________________  
 
 
This part must be completed by the Investigator (or his/her representative): 
I have explained to Mr. _________________________________________________ the 
nature and purposes of the research; I have explained to him/her about the risks and 
benefits involved in his/her participation. I have answered questions to the extent possible 
and have asked if he/she has any doubts. I agree that I have read and know the relevant 
regulations for conducting research with human subjects and I adhere to them. Once the 
question and answer session was concluded, the present document was signed. 
 
 
 
 
_____________________________________ _____________________  
Researcher's signature Date of registration