Evaluation of Ophthalmic Lenses for Myopia Management
Phase: NA
Conditions: Myopia
Sponsor: Indizen Optical Technologies, S.L.U.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation of ophthalmic lenses for 
myopia management 
Project code: IOT-MIO-2018-01 
 
 
 
 
 
 
 
April 26, 2021 
 

C/ Suero de Quiñones 34-36 3º 
28002 Madrid, Spain 
(+34 )91 833 37 86 
 
 
1. State of the art 
Myopia currently affects approximately 30% of the global population, although it is estimated that 
the prevalence will increase to 50% by 2050. According to these predictions, about 5 billion people 
will be nearsighted by 2050. 
Although it is not clear what different factors may contribute to the onset and development of 
myopia, some studies have suggested that myopia is a multifactorial consequence involving 
numerous genetic, ethical, and environmental factors. 
Experimental studies using animal models have suggested different strategies to control the growth 
of the eye and consequently the evolution of myopia progression. The results of these studies have 
shown that the visual signal related to retinal defocus controls the refractive development of the eye. 
Thus, visual signals in the periphery of the retina cause changes in growth that affect axial length and 
central refraction. On the other hand, animal studies have shown that imposing myopic defocus in 
the periphery inhibits eye growth. 
Although the results of studies provide sufficient evidence of the efficacy of different clinical 
interventions for myopia control, there are still unresolved questions related to the underlying 
mechanisms. This includes, but is not limited to, the contribution of central and peripheral retinal 
regions to the regulation of eye growth, as well as the influence of aberration changes such as positive 
spherical aberration. 
 
1.1. 
Human studies with glasses for myopia control 
There are different options being worked on to prevent or delay the onset of myopia, from an optical, 
pharmacological, environmental, and surgical perspective. However, the option of using glasses to 
delay myopia progression has quite a few advantages compared to other myopia control strategies: 
they are easy to fit, they are well accepted and tolerated, they are affordable for most, and they are 
minimally invasive. 
The different myopia management spectacles options that have been worked on are as follows: 
 
Under-correction for distance vision around +0.50D to +0.75D has been a strategy used in 
clinical practice for many years to reduce myopia progression. However, recent studies have 
shown that it provides no proven benefit compared to full correction. 
 
 
 
 
 
 
 
 
 
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 
Bifocal lenses to reduce accommodative demand and/or reduce accommodative lag during 
near tasks. Most published studies suggest that there is no difference in myopia progression 
between single-vision and bifocal wearers. 
 
 
Figure 1. Results of clinical studies that have evaluated the efficacy of bifocal lenses as a treatment for myopia 
management. 
 
 
Progressive lenses have been the most studied spectacle treatment. The results have shown 
positive effects of their use as a treatment for myopia, but these effects are questionable from 
a clinical point of view. 
 
Figure 2. Results of clinical studies that have evaluated the efficacy of progressive lenses as a treatment for myopia 
management. 
 
 
 
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 
Single vision lenses that induce positive defocus in the periphery: These lenses are 
characterized by having an optical zone free of defocus and a peripheral zone that has a 
positive defocus induced from +1.00 to +3.50D. The results of these lenses show moderate 
benefits, being the lenses with smaller optical zone and higher peripheral defocus power the 
ones that have shown a greater delay in myopia progression. 
 
 
Figure 3. Results of clinical studies that have evaluated the efficacy of single vision lenses that induce positive defocus in 
the periphery as a treatment for myopia management. 
 
 
Other options: Finally, in recent years different lenses specifically designed for myopia 
management have been presented that induce a reduction of visual quality in the periphery of 
the lens by different techniques such as the use of microlenses (Miyosmart lens, Hoya and 
Stellest, Essilor), asymmetric positive defocus (Perifocal Lens) or scattering by laser (DOT 
Lens, SightGlass), whose results appear to be promising. 
Figure 4. Results of clinical studies that have evaluated the efficacy of new lenses as a treatment for myopia management. 
 
 
 
 
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Bibliography 
Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. 
Ophthalmology 2016; 123:1036-1042. 
Gifford KL, Richdale K, Kang P, et al. IMI - Clinical Management Guidelines Report. Invest Ophthalmol Vis Sci 2019;60:M184-M203 Troilo D, Smith 
EL, 3rd, Nickla DL, et al. IMI - Report on Experimental Models of Emmetropization and Myopia. Invest Ophthalmol Vis Sci 
2019;60:M31-M88 
Wildsoet CF, Chia A, Cho P, et al. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. 
Invest Ophthalmol Vis Sci 2019;60:M106-M131. 
Tarutta, E.P. et al, Long-term results of perifocal defocus spectacle lens correction in children with progressive myopia. ʝ$ИГИʜАЛ0ʜ/Е %&А&0И, 2019 
 
 
2. Justification 
During the last few years, myopia has been recognized as a public health problem that causes 
significant vision loss and is also a risk factor for the development of other important ocular 
conditions. The prevalence of this condition is increasing globally for reasons that are still unknown. 
Therefore, this increase in myopia has important implications for an adequate vision care service, 
including refraction services such as spectacle prescription and myopia prevention and management 
systems, especially in those with high degrees of myopia. 
Previous studies in animal models have shown that retinal defocus plays an important role in the 
emmetropization process of the eye and therefore in the development and progression of myopia. 
According to published studies, optical compensation that includes an alteration of image quality in 
the periphery of the retina produces a decrease in myopia progression, with lenses with smaller 
optical zone and greater peripheral defocus showing greater efficacy. Based on previous literature, 
different ophthalmic lens prototypes have been developed consisting of a central optical zone 
surrounded by a peripheral zone that induces a reduction in optical quality. 
In this study we propose to conduct a controlled study to evaluate the safety and effectiveness of the 
proposed ophthalmic lens prototypes as a myopia control system. 
 
3. Hypothesis 
The proposed ophthalmic lenses provide an adequate level of visual function while helping to slow 
the progression of myopia in myopic children. 
 
 
 
 
 
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4. Goal 

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28002 Madrid, Spain 
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The main purpose of this study is to evaluate the short-term efficacy in decreasing myopia 
progression of 2 different prototypes of proposed ophthalmic lenses, compared to a control group, in 
a group of myopic children.
 
5. Methodology 
5.1. 
Type of study 
Double-blind experimental study to analyze the effect of 2 ophthalmic lens prototypes on myopia 
progression. The follow-up period to evaluate the efficacy of the lens will be 6 months including a 
total of 4 visits. 
5.2. 
Subjects of the study 
The sample will consist of a group of 92 myopic children who must meet the inclusion/exclusion 
criteria indicated in Table 1 and who will be randomly assigned to one of the treatment groups: 
- 
Control group who will receive a standard single vision lens. 
- 
Group 1 who will wear a prototype lens based on peripheral positive defocus. 
 
Inclusion criteria 
Exclusion criteria 
 
- 
Age: 5 to 12 years  
- 
Myopia (spherical equivalent with 
cycloplegic) f -0.50D 
- 
Astigmatism < 1.50D 
- 
Anisometropia < 1.50D 
- 
Best-corrected visual acuity g 20/20 
 
- 
Patients who have received any 
previous treatment for myopia 
control, including the use of RPG 
contact lenses. 
- 
Participants with ocular pathology 
such as retinal detachment. 
- 
Participants using drugs that may 
affect pupillary size and 
accommodation or produce effects 
on the ocular surface. 
- 
Participants with systemic diseases 
that may affect their vision. 
 
5.3. 
Material 
Table 1.   Inclusion/Exclusion criteria 
 
 
 
5.3.1. Facilities and infrastructure 
 
 
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The study will be coordinated at the offices of Indizen Optical Technologies (Madrid, Spain) and the 
ophthalmological 
measurements 
will 
be 
performed 
in 
collaboration 
with 
Clinica 
Novovisión/Universidad Europea de Madrid, with a collaboration agreement to be defined. The 
children will be recruited by the Amires association. 
5.3.2. Tests, questionnaires, and instruments for optometric and ophthalmologic 
evaluation: 
 
 Sociodemographic questionnaire: participants' parents will complete a questionnaire that 
includes information regarding age, sex, ocular and general history, ocular surgeries, history of 
parents with myopia, age of onset of myopia, history of myopia progression and previous ocular 
treatments. 
 Objective refraction: will be performed using an autorefractometer after cycloplegic using 
preferably 3 drops of cyclopentolate. 
 Ocular health assessment: It will be performed according to Novovisión's standard procedures. 
 Biometry: the axial length of the eye will be measured with the optical biometer preferably IOL 
Master (Carl Zeiss Meditec, Jena, Germany). 
 Binocular vision: Distance and near phoria will be measured by Von Graefe’s technique, the 
accommodative amplitude will be measured by Sheard method, and accommodative lag by 
MEM retinoscopy. 
 Usability questionnaires: Questionnaires to assess children's satisfaction while wearing the 
spectacles, to record the wearing period and spectacle-associated problems and adverse effects. 
5.3.3. Prototypes of ophthalmic lenses: 
All lenses and frames required for the study will be provided by Indizen Optical Technologies. For 
the duration of the study, glasses will be provided free of charge (lenses + frames) ensuring that 
children always have a spare pair of glasses. In addition, we will change the lenses and glasses free of 
charge in case the prescription changes or the glasses break. Likewise, the ophthalmological 
examinations will be completely free of charge, so that the participation in the study does not entail 
any cost or commitment for the participants. 
Children can be assigned to one of the three types of lenses to be tested: 
- Control lenses: Standard spherocylindrical lenses. 
- Prototype 1 lens: Lenses with a central zone that provides the patient's optimal prescription 
surrounded by a zone of positive defocus that increases progressively from the center to the 
periphery of the lens, in an asymmetrical manner between the different zones of the lens. 
 
 
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28002 Madrid, Spain 
(+34 )91 833 37 86 
 
 
5.4. 
Procedure 
- 
Visit 1 (Recruitment and Baseline measurements): The optometrist will provide information 
about the study to the parents of the children, who then signed a written consent form after any 
doubts will be cleared up. The optometrist also will check that the children met the inclusion 
criteria. In this same visit, baseline measurements will be taken. All children shall be submitted an 
ophthalmology exam to evaluate their ocular health, and their cycloplegic autorefraction, 
binocular vision, and axial length will be recorded in the case report form. Additionally, parents 
will complete a sociodemographic questionnaire, and the children will select the frames for their 
spectacles. 
Once the visit is completed, the IOT team will order 2 pairs of glasses with the same prescription and 
customization parameters, which will be the final glasses that the participants will wear during the 
study period. Before delivering the glasses to the participants, a full quality control will be performed 
on the quality and fit of the lenses. 
- Visit 2 (Delivery of glasses): Previous glasses are removed, and 2 new glasses will be delivered to 
be used during the study period. Verification of fit and delivery of glasses usability questionnaire. 
- Visit 3 (6 months follow-up): Collection of spectacle usability questionnaire and data collection 
after treatment period. Ophthalmological data will be recorded after treatment including 
cycloplegic refraction, biometry, and usability questionnaires. 
- Visit 4 (12 months follow-up): Collection of spectacle usability questionnaire and data collection 
after treatment period. Ophthalmological data will be recorded after treatment including 
cycloplegic refraction, biometry, and usability questionnaires. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 8 of 10 

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28002 Madrid, Spain 
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Task 
Responsible Partner 
Recruitment 
Amires 
Visit 
1: 
Patient 
information, 
verification 
of 
criteria, 
ophthalmological evaluation, and 
selection of frames. 
Clinica Novovisión/Universidad 
Europea de Madrid/IOT 
Visit 2: Delivery of glasses 
IOT 
Visit 3: 6 months follow-up 
Clinica Novovisión/Universidad 
Europea de Madrid 
Visit 4: 12 months follow-up 
Clinica Novovisión/Universidad 
Europea de Madrid 
Statistical analysis and final report 
IOT/ Clinica 
Novovisión/Universidad Europea 
de Madrid 
 
 
5.5. 
Data collection and statistical analysis plan 
All variables for each individual and in each phase will be collected in the data collection notebook 
designed for this purpose. All data will be included in a database developed for this purpose for 
subsequent statistical analysis. The main variables of the study will be the values of axial length and 
refraction with cycloplegia. 
A comparative statistical analysis of absolute (mm) and relative (%) axial length growth between the 
lens for the management of myopia and the standard single vision lens groups will be done done 
using the software STATA®. Absolute axial length growth will be calculated as median relative 
difference after 6 and 12 months of treatment as (AL at 6m – baseline AL)/ baseline AL *100 and (AL 
at 12m – baseline AL)/ baseline AL *100, respectively. Significance level will be set as p-value < 0.05. 
Efficacy of myopia management lenses will be evaluated by comparing the means of relative axial 
length growth in children treated with myopia management lenses to that of children treated with 
the standard single vision group. 
 
 
 
 
 
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C/ Suero de Quiñones 34-36 3º 
28002 Madrid, Spain 
(+34 )91 833 37 86