EsSiLOr Stellest Lenses Multicentre European Study

Myopia (short-sightedness) prevalence varies markedly across the globe, with
13.9% of South Asia and 22.8% of white populations affected by age 18, whilst
almost 80% of East Asians are myopic by 18 years of age. In addition to
ethnicity, educational pressure and limited time spent outdoors are risk
factors for myopia development. A thin, stretched retina due to axial
elongation, particularly in higher degrees of myopia, can lead to blinding
ocular pathology including retinal detachment and myopic maculopathy, while
lower levels of myopia is significantly associated with the two most common
ocular diseases; glaucoma and cataract.
Considering that almost 50% of the world*s population are expected to be myopic
by 2050 with approximately 10% of those being affected by high myopia
(*-5.00D), it is not surprising that many clinical trials have focused on
developing viable myopia control treatments such as atropine eye drops, contact
lenses, including multifocal soft contact lenses, and ortho-keratology, in
addition to multifocal spectacle lenses including bifocals, progressive
addition lenses (PALs), and peripheral defocus lenses.
Such above-mentioned myopia control methods have various levels of efficacy.
Low-dose atropine eye drops have been reported to reduce myopia progression by
50-59%, but have still not been approved for myopia control use. Myopia control
soft contact lenses and ortho-keratology are commercially available treatment
options, reported to reduce myopia progression by 52-59% and 46% - 56%
respectively. Nonetheless, these methods are invasive and may not be suitable
for young children.
Myopic children wear single vision spectacles as part of their daily routine.
Consequently, myopia control lenses are a simple treatment option, inbuilt to
spectacles with the added benefit of slowing myopia progression. Until
recently, bifocals were the best myopia control spectacles with a three- year
treatment effect of 33-51%, dependent on lag of accommodation and whether
bifocal or prismatic bifocal spectacles were used.18 However, bifocals have
aesthetical limitations. More recent lens designs apply persistent peripheral
myopic defocus on the retina to slow myopia progression.22- 25,28 Spectacle
lenses with highly aspherical lenslets (HAL) demonstrated a reduction in myopic
SER by 55% (0.8D) and axial length by 51% (0.35mm) compared to single vision
lenses (SVL), over a two-year period.22 Although very promising results, this
study was conducted on Chinese children only.
Extrapolation to other population* is limited due to ethnic differences in
myopia prevalence, even when children are living in the same country and
exposed to the same schooling environment.29 Considering this, investigation of
the efficacy and safety of the HAL spectacle lenses (Essilor® Stellest®) is the
primary aim of this study.

To demonstrate the efficacy, safety, acceptability, and quality of life
implications of Essilor® Stellest® spectacle lenses in slowing myopia
progression in children and adolescents.

Multicentre, international, prospective, interventional study with single group
assignment
All participants receive Essilor® Stellest® at inclusion visit.
Active treatment period: 24 months for all participants

Essilor® Stellest® spectacle lenses

Cycloplegic eye drops are used by optometrists and ophthalmologists daily and
are extremely unlikely to cause unusual symptoms due to an adverse reaction.
These include pain and redness in or around the eyes, feeling disorientated,
incoherent speech, visual disturbances and racing pulse or palpitations. The
risk of these occurring is the same as the routine use of cycloplegic eye drops
in optometry or ophthalmology eye clinics. Participants and their parents will
be advised to contact their optometrist, ophthalmologist or seek advice
immediately if the participant experiences any unusual symptoms. Additionally,
slit lamp examination of the anterior chamber angle will be conducted prior to
drop instillation as a precaution to ensure it is safe to perform cycloplegia.
Participants and their parents will also be advised on the expected symptoms
associated with cycloplegic eye drops. These include photophobia due to larger
pupil size and blurred near vision due to temporarily altering the near-focus
system. Symptoms should not persist longer than 24 hours, and the participant*s
will be advised to contact their optometrist, ophthalmologist or seek medical
advice should this be the case. Wearing sunglasses or a peaked cap for
following cycloplegia, will also be advised, to minimise photophobia and
protect the eyes from glare.
The spectacle lens under test (Essilor® Stellest®) is designed to cause
peripheral myopic defocus and are deemed safe and without side effects on
peripheral vision development in Chinese children. Other studies investigating
the effect of myopia progression with multifocal contact lenses,11 progression
addition21 and peripheral defocus spectacle lenses25 have not reported to
affect peripheral vision development.
Considering the above, there are minimal risks associated with the study
examination and the effect of the investigational device on peripheral vision
development. These are outweighed by the benefits of guaranteed myopia control,
and reduction in the risk of associated visual impairment for all participants
enrolled.