Year XXIII, N. 7, May 2020
Innovation in Ophthalmology
Treatment with Waterfall artificial tears in patients
with alterations and dysfunction of the cornea and lacrimal
apparatusDavid Ciacci, Francesca Jonsson
O
Year XXIII, N. 7, May 2020
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the cornea and lacrimal apparatus David Ciacci, Francesca Jonsson
ISBN 978-88-6756-553-5ISSN 2035-0252
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Contents
Abstract 2
Introduction 2
Objective 4
Materials and methods 4
Results 5
Conclusions 7
References 7
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the cornea and lacrimal apparatusDavid Ciacci1, Francesca Jonsson2
1 Head of Ophthalmology, Chiros Srl, Turin, Italy; Director of Ophthalmology Service, Cidimu Group SpA, Turin, Italy; IRR Rehabilitations Institute, Turin, Italy2 Orthoptist and Ophthalmic Assistant, Chiros Srl, Turin, Italy; Ophthalmology Service, Cidimu Group SpA, Turin, Italy; IRR Rehabilitations Institute, Turin, Italy
2
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the cornea and lacrimal apparatus
Abstract
The objective of this 3-month study was to
evaluate the effects of artificial tears in im-
proving the subjective symptoms and ob-
jective parameters of patients suffering from
tear dysfunction or corneal disorders.
The study was conducted on 11 subjects se-
lected from among patients with subjective
qualitative lacrimal disorders and corneal
dysfunction or alterations, such as corneal
dystrophies or pre-existing keratopathies,
either concomitant with systemic diseases
or following ophthalmological interven-
tions. The subjects used Waterfall tear re-
placement drops for a period of 90 days and
both subjective and objective assessments
were carried out in three successive steps
by means of specific tests and question-
naires.
The response and tolerance of the patients
who used Waterfall eye drops and benefit-
ed from the instillation was good, in terms
of both subjectively reported symptoms and
objective improvement of the corneal and
tear film parameters.
Introduction
Keratopathies represent a heterogeneous
group of non-inflammatory conditions
affecting the cornea; these may remain
asymp tomatic for a long time and therefore
go undiagnosed, or they may cause serious
subjective disturbances in patients with sec-
ondary lacrimal dysfunction. Keratopathies
may be congenital and be caused by gene
mutations, as in cornea guttata, or acquired
and/or concomitant to systemic diseases.
The corneal endothelium, the stroma and
the corneal epithelium are generally affect-
ed. The main symptoms reported by the pa-
tients are nonspecific and consist of ocular
dryness, increased blinking, photophobia,
foreign body sensation and general eye dis-
comfort[1].
In addition, dry eye is a common though fre-
quently under-recognized disorder whose
etiology and management constitutes a
challenge for both clinicians and research-
ers. Advances in the understanding of the
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the corneaand lacrimal apparatus
3
disease have been made over the past 10
years in areas of epidemiology, pathogen-
esis, clinical manifestations, and possible
therapy.
The most recent classification of dry eye dis-
ease (DED) is the one provided by the report
of the Definition and Classification Subcom-
mittee of the International Dry Eye Work-
shop (DEWS, 2007): “Dry eye is a multifac-
torial disease of the tears and ocular surface
that results in symptoms of discomfort, with
potential damage to the ocular surface. It is
accompanied by increased osmolarity of the
tear film and inflammation of the ocular
surface”[2].
In the latest update published in 2017, the
DEWS II defines it as a “multifactorial dis-
ease of the ocular surface characterized by
a loss of homeostasis of the tear film, and
accompanied by ocular symptoms, in which
tear film instability and hyperosmolarity,
ocular surface inflammation and damage,
and neurosensory abnormalities play etio-
logical roles”[3].
A summary of the data indicates that the
prevalence of dry eye ranges between 5-30%
in the population aged 50 years and older.
There is international agreement that the
prevalence of severe disease is most prob-
ably at the low end of this range while that
of mild or episodic disease is closer to the
upper end of this range[4].
Changes in visual performance in con-
junction with discomfort can contribute
to decreased quality of life (QoL) among
patients with DED[5]. As DED common-
ly presents as a foreign-body sensation,
burning or stinging, and/or photophobia, it
can contribute to blurred vision and contact
lens intolerance. Visual acuity after sus-
tained eye opening, or ‘functional’ visual
acuity (believed to simulate an individual’s
vision while reading, driving, and working
at a computer screen), appears specifically
impaired by DED.
Figure 1 and Figure 2 show examples of
dry eye.
Figure 1. Dry eye with stromal invasion of the vessels.
Figure 2. Dry eye.
4
Objective
The objectives of this study were to evaluate
the effects of artificial tears in improving the
subjective symptoms of tear dysfunction or
corneal disorders and thus the patients’ vi-
sual wellbeing and to establish whether this
improvement corresponded to an objective
improvement of the ocular parameters mea-
surable with diagnostic tests.
Materials and methods
The study was conducted on a sample of
11 patients suffering from congenital or ac-
quired corneal disorders (cornea guttata,
keratopathies, corneal dystrophies) and tear
alterations with serious subjective disorders.
The study participants were selected from a
sample of 25 patients who were examined
and interviewed so as to exclude those af-
fected by pathological conditions likely to
reduce cohort homogeneity or that might
interfere with the results.
The ophthalmologist (D.C.) collected the pa-
tients’ ophthalmological history and state-
ments, after having carried out a complete
ophthalmological examination comprising
slit-lamp biomicroscopy. He also performed
a series of diagnostic tests, including tear
film break-up time (BUT), endothelial cell
count, Schirmer’s test, meibography, and
tear osmolarity analysis.
The parameters assessed were the BUT test,
the endothelial cell count and the Ocular
Surface Disease Index (OSDI) score – all
measured at baseline and at the end of the
study – as well as an individual question-
naire administered at the end of the study.
The study had a total duration of 90 days
and was divided into three main steps:
• 1st visit (time 0), in which the patients un-
derwent complete eye examination, BUT
test, endothelial cell count and OSDI as-
sessment;
• 2nd visit (time 0 + 30 days), in which adher-
ence to therapy was assessed through an
eye examination and tolerance to the arti-
ficial tears through an interview, and the
correct use of the eye drops was verified;
• 3rd visit (time 0 + 90 days), in which the
patients underwent complete eye exam-
ination, BUT test, endothelial cell count
and OSDI assessment, in addition to
completing a patient satisfaction ques-
tionnaire on the use of the eye drops.
The BUT tests were performed using a
SIRIUS corneal topographer without the
use of fluorescein; the patient was asked to
blink twice and then to keep the eye open
for as long as possible. The endothelial cell
count was carried out using a computerized
no-contact instrument that analyzed endo-
thelial cell density and structure (polymega-
thism and pleomorphisms). The OSDI ques-
tionnaire was used to investigate the impact
of symptoms on the patient’s daily life.
The new Waterfall product is a multidose,
preservative-free, ophthalmic hypotonic gel
containing hyaluronic acid 0.4% and Kol-
liphor P407. It is a medical device that helps
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the corneaand lacrimal apparatus
5
Results
A total of 11 patients were studied over a pe-
riod of 90 days. Nine patients completed the
study; two patients discontinued treatment
after 1 month because of intolerance to the
eye drops attributed to their excessive stick-
iness.
The patient satisfaction questionnaire re-
vealed an overall subjective improvement
in all patients who used Waterfall gel drops,
with good tolerance and good compliance
with the product. In detail, 67% of patients
reported a marked subjective improvement
in symptoms and QoL, whereas 33% re-
ported only a relative improvement with no
change in symptoms compared with the be-
ginning of the study (Figure 3).
The results of the BUT test and endothelial
cell count showed an overall objective im-
provement of the ophthalmological param-
eters, with an increase in the BUT values
(Figure 4) and a slight increase in corneal
cell density in many patients.
to keep the eye hydrated and to protect the
ocular surface by forming a protective film.
Thanks to an innovative formulation, Wa-
terfall gel drops have thermo-thickening
properties: from an easy-to-instil, aqueous
solution in the bottle, the gel drops become
viscous once instilled into the eye, thereby
adhering better to the ocular surface and
ensuring hydration and protection.
In our study, Waterfall tear replacement was
instilled 3 times daily, instructing patients to
keep the eyes closed for about 20 seconds
after instillation so as to improve patient
acceptability. The corneal residence time of
an artificial tear plays an important role in
terms of protection, symptom relief and also
compliance. The innovative aspect of Water-
fall gel is its ability to become a gel after be-
ing instilled into the eye, thereby ensuring
long-lasting hydration and protection of the
ocular surface. Particular attention was paid
to the method of instillation, the number of
instillations and the constancy of treatment
over the 90 days of the study. The eye drops
were provided to all patients by our center.
All the patients were particularly motivated
owing to their clinical situation and attend-
ed all of the scheduled follow-up appoint-
ments without exception, allowing for a pre-
cise and thorough evaluation of the results.
Figure 3. Quality of Life: 67% of patients reported a marked subjective improvement in symptoms and quality of life, whereas 33% reported only a relative improvement with no change in symp-toms compared with the beginning of the study.
Improved
Unchanged
67%
33%
6
In particular, there was an improvement in
scores on the OSDI questionnaire adminis-
tered to the patients at baseline and at the
end of the study, indicating a reduction in
the impact of ophthalmological discomfort
on the patients’ daily life (Figure 5).
Figure 5. Ocular Surface Disease Index (OSDI). The OSDI questionnaire was used to investigate the impact of symptoms on the patient’s daily life. The improvement of OSDI scores from baseline to study end indicates a lower impact of ocular symptoms on the patient’s daily life. The four patients with the best results are shown.
OSD
I tot
al s
core
0
10
20
45
Patient 2
15
4
23
11
39
13
9
1
Patient 3 Patient 4 Patient 7
40
30
5
15
35
25
1st visit
3rd visit
Figure 4. Break-Up Time (BUT) test. The BUT tests were performed using a SIRIUS corneal topographer without the use of fluorescein; the patient was asked to blink twice in a row and then to keep the eye open for as long as possible. Results show an overall objective improvement of the ophthalmological parameters with an increase in BUT test values. The three patients with the best results are shown.
1.2 1.2
4.3Brea
k-U
p Ti
me
(sec
)
0
4
8
18Patient 1
1st Visit
10.4
16.8
15.4
3rd Visit
10
14
2
6
16
12
Patient 2
Patient 3
Treatment with Waterfall artificial tears in patients with alterations and dysfunction of the corneaand lacrimal apparatus
7
Conclusions
Between September and December 2019,
Waterfall eye drops were used on a selection
of 11 patients affected by dry eye disease
and keratopathy. The response and tolerance
of the patients who used the hypotonic eye
drops and benefited from the instillation was
good, in terms of both subjectively reported
symptoms and objective improvement of the
corneal and tear film parameters. The eye
drops were well tolerated, with only some
initial discomfort after instillation and good
compliance with the treatment over the fol-
lowing weeks. From an ophthalmological
viewpoint, the use of Waterfall eye drops
produced a reduction of the patients’ dis-
comfort and symptoms, with an increase in
BUT test values and, to a lesser extent, in cell
density.
In summary, the use of Waterfall hypoton-
ic eye drops, which may be combined with
anti-hypertensive or anti-inflammatory
therapy, seems to allow an early qualitative
improvement of vision, with a reduction
of all symptoms related to conditions such
as tear-film dysfunction, keratopathy, and
corneal dystrophy. The ophthalmological
improvement results in a better quality of
life for the patients.
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tore, 1986.
2. Dry Eye Workshop Subcommittee. The definition and classification of dry eye disease:
report of the Definition and Classification Subcommittee of the International Dry Eye
WorkShop (2007). Ocul Surf 2007;5(2):75–92.
3. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report.
Ocul Surf 2017;15(3):276–83.
4. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the
International Dry Eye WorkShop (2007). Ocul Surf 2007;5(2):93–107.
5. Friedman NJ. Impact of dry eye disease and treatment on quality of life. Curr Opin Oph-
thalmol 2010;21(4):310–16.