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UK EDITION
SUMMER 2012 / ISSUE 13
Glistening-free, hydrophobic acrylic IOL
JUST SAY ‘NO’
TO GLISTENINGS
PAGE 10
Pure Vision 2 for astigmatism
4
with high definition optics
CE mark approval for Victus
13
Femtosecond Laser Platform
Bausch + Lomb instruments –
16
made in Germany
Focus on glaucoma
7
The science of Preservative14
Associated Transient
new, modern tool for managing
18Apost-cataract
inflammation
®
™
Hyperfluorescence (PATH)
GIVE YOUR PATIENTS CONSISTENTLY
CRISP, CLEAR VISION
THROUGHOUT THE DAY
NEW P
ureVision®2 contact lenses for Astigmatism
with High DefinitionTM Optics
A
uto Align DesignTM – delivers outstanding stability for consistently crisp,
clear vision throughout the day
l High Definition™ Optics – for crisp, clear vision especially in low light.
The only silicone hydrogel toric lens to control spherical aberration in
both the sphere and cylinder meridians of the lens
lC
omfortMoistTM – improves comfort on insertion and throughout the day
l
BiotrueTM is the recommended multi-purpose solution, helping keep lenses
moist for up to 20 hours1
1
Results of a US in vitro study performed to evaluate the release of wetting agents from various silicone hydrogel lens materials over a period of 20 hours.
©2011 Bausch & Lomb Incorporated. ®/™ denote trademarks of Bausch & Lomb Incorporated.
COMING SOON – APRIL 2012
To find out more, speak to your Bausch + Lomb Sales Representative today or call customer services, details listed opposite.
3
DEAR COLLEAGUES
Welcome to the Summer edition of Visions magazine. We look forward
to meeting many of you at the major congresses in the coming months.
Bausch + Lomb is one of the best-known and most respected healthcare
brands in the world, offering the widest and finest range of eye health
products. Our contact lens and lens care offerings span the entire
spectrum of wearing modalities.
Our pharmaceutical products treat a wide range of eye conditions
including glaucoma, eye allergies, conjunctivitis, dry eye and retinal
diseases. We offer branded and generic prescription ophthalmic
pharmaceuticals as well as a wide variety of over-the-counter eye
health products.
We offer a full suite of ophthalmic surgical products, intraocular
lenses (IOLs) and delivery systems. Bausch + Lomb’s centres
for research, development and manufacturing are located
throughout the world and our products are sold in more
than 100 countries.
We look forward to partnering with you to meet the
challenges and celebrate the successes of the year ahead.
Jill Collishaw, Editor, Visions Magazine
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4
MAGAZINE
Throughout the history of contact lens
design the challenge of meeting the
needs of astigmatic individuals has
been significant. It is important to
continue to strive to meet those needs
when we consider the population that
requires this correction. It has been
reported that approximately 37% to
45% of adults have 0.75D or more of
astigmatism.1‑3 With almost half of the
population of contact lens wearers
having significant astigmatism2, the
contact lens industry as a whole must
continue to support the needs of this
large group of patients.
PUREVISION 2
®
FOR ASTIGMATISM WITH HIGH DEFINITION OPTICS
In a survey of 201 astigmatic contact lens
wearers, the symptoms most often cited while
wearing current toric lenses included regularly
or occasionally experiencing blurry/hazy vision,
fluctuating vision, and distorted vision.4 Forty seven
percent of subjects reported experiencing blurry
or hazy vision, 37% reported fluctuating vision,
and 32% reporting distorted vision. Additionally,
32% of toric patients reported experiencing glare
and halos in low-light conditions. Product benefits
of toric lenses (in the categories of vision, comfort,
health and convenience) were presented to
patients randomly in successive groups of four for
ranking. The benefit of highest relative importance
for a toric soft contact lens was that it should ‘deliver
consistently sharp vision all day’. Attributes and
performance of current toric lenses may limit the
ability of patients to achieve consistently crisp, clear
vision throughout the day. Patients are looking for
contact lenses that offer uncompromised vision and
stability without compromising comfort.
Definition™ Optics. Three lens design attributes
have been incorporated to work together and
achieve exceptional toric lens performance:
High Definition™ Optics, Auto-Align Design™,
and ComfortMoist™ Technology.
Design Attributes and
Clinical Experience
A conventional spherical contact lens does
not consistently control spherical aberration
across the power range. Spherical lens designs
inherently demonstrate spherical aberration due
to their highly curved spherical surfaces; negative
spherical aberration for negative power lenses, and
Addressing the needs of astigmatic patients
was the primary goal when Bausch + Lomb
designed PureVision®2 For Astigmatism with High
High DefinitionTM Optics
Spherical aberration is the inability of the eye to
focus light rays passing simultaneously through
the centre and the periphery of the eye. The retinal
image appears blurred because the peripheral light
rays are focused anterior to the retina (Figure 1).
Spherical aberration can be a barrier to highquality vision in low light, resulting in blurred vision,
halos and glare. Bausch + Lomb lenses with
High Definition™ Optics are designed to reduce
the positive spherical aberration that is naturally
occurring in the human eye to minimise halos and
glare and bring all of the light rays to the same focal
point to create clear, crisp vision all day – especially
in low light. (Figure 2).
Figure 1. A lens with spherical aberration has different
focal points for the light rays passing through the center
and the periphery of the lens.
Figure 2. Bausch + Lomb lenses with High DefinitionTM Optics
are designed to reduce the positive spherical aberration that is
naturally occurring in the human eye and bring all of the light rays
to the same focal point.
5
positive spherical aberration for positive power
lenses, in proportion to their back vertex power.
Aspheric Bausch + Lomb contact lenses with High
DefinitionTM Optics are designed to reduce the
inherent spherical aberration of the eye and reduce
the spherical aberration induced by the contact lens
on-eye.
PureVision®2 HD For Astigmatism was designed
with High Definition™ Optics to reduce spherical
aberration in both the sphere and cylinder
meridians, in quarter dioptre steps across the
power range, for clear, crisp vision all day –
especially in low light. PureVision®2 HD For
Astigmatism is the only silicone hydrogel toric soft
contact lens that reduces spherical aberration on
both the spherical and cylinder meridians of the
lens. By controlling spherical aberration in both the
sphere and cylinder meridians, PureVision®2 HD
For Astigmatism corrects for not only astigmatism
and spherical aberration, but also reduces
secondary astigmatism.
It has been reported
that approximately
37% to 45% of adults
have 0.75D or more
of astigmatism.1–3
When the eyelids close during a complete blink,
there is a slight downward displacement of the
lens and the lids typically meet at a point 1–2mm
from the base of the lens. For a lens to effectively
leverage these blink dynamics and maintain stable
orientation, the toric stabilizing ballast should be
designed with this in mind. By positioning the
maximum ballast thickness low on the lens, the
design can leverage the full motion of the upper
lid while gaining support from the lower lid.
Understanding eyelid movement during the blink
and lens movement associated with eye and eyelid
movement helped guide the development of the
Auto-Align Design™ feature of PureVision®2 HD
For Astigmatism. This feature allows the lens to
achieve stability and orientation while providing
consistently crisp, clear vision throughout the day.
With optimized ballasting, a large lens diameter,
and a large optic zone, PureVision®2 HD For
Astigmatism minimizes lens mis-rotation to help
ensure outstanding stability and vision throughout
the day.
ComfortMoist™ Technology
ComfortMoistTM Technology has two key features: a
thin lens design to provide a natural feel throughout
the day and a moisture-rich packaging solution
to provide excellent comfort upon insertion.
PureVision®2 HD For Astigmatism continues to
use a thin rounded edge design from PureVision®2
HD sphere, to enable a smooth, gentle transition
of the lid from the lens to the conjunctival. The new
lens design also features reduced lens markings
providing a more continuously smooth surface.
Auto-Align Design™
The stability of a toric lens is governed by several
forces. Those forces can be divided into static
(which include surface tension of the tears, gravity,
conformity of the lens, and lid pressure at the top
and/or bottom of the lens) and dynamic forces
(which include upper and lower eyelid movement
and eye movement). To better understand how
lenses behave on-eye, several experiments were
undertaken to understand one of the main drivers
of instability; blinking dynamics. Blinking is essential
to maintenance of the ocular surface and occurs
at a speed that is almost imperceptible. The main
muscle drivers of the blink are the horizontally
aligned obicularis oculi and the more vertically
aligned, levator palpaebra and Muler’s muscles.
To capture the motion of these muscles, a high
speed camera, capable of recording 300 frames
per second was employed. The results showed
that from initiation to completion of the natural
blink, only 1 tenth of a second passes. In that time
the upper lid has traveled approximately 7.5 mm
down and 4.8 mm nasal. Interestingly, the lower
lid has limited vertical motion, leaving the upper
lid to be almost entirely responsible for rewetting
the ocular surface through the blink mechanics.
Understanding these dynamics helps design a
lens which can work with the dynamic range of
the eyelids.
compared to PureVision® Toric (Figure 3).
This helps create a more comfortable wearing
experience, while maintaining the same large optic
zone as PureVision® Toric. The large optic zone
(8.0mm for a –3.00 –1.25x180 lens) also helps to
reduce potential glare in low light conditions.
Clinical Findings
A
B
Figure 3. Thickness profiles of PureVision®2 HD For
Astigmatism (a) and PureVision® Toric (b), where the red color
indicates the thickest portions of the lens and the blue color
represents the thinnest portions of the lens.
Maintaining the stability of the optic in the eye while
providing comfortable, all day wear, is a critical
balance manufacturers face. Various innovative
techniques have been employed to create a stable
contact lens including truncation, dual slab-off, peri
ballast and prism ballast, to name a few, and there
are multiple designs currently commercialized
which are founded on these basic geometries.
The new PureVision®2 HD For Astigmatism lens
is founded on solid understanding of contact lens
stability techniques. Sophisticated lens design
software and innovative manufacturing techniques
have allowed Bausch + Lomb to develop a lens that
uses the best aspects of prism and peri ballasting
to create a hybrid ballasting system. The design
provides excellent stability for consistent vision, with
repeatable orientation even with the blink and eye
movement. Manufacturing sophistication has also
come of age and is carefully sculpting the contours
of these lenses to blend with and work with the eye
To improve centration, PureVision®2 HD For
Astigmatism was designed with a larger diameter
compared to PureVision® Toric. PureVision®2
HD For Astigmatism was designed with a 14.5mm
outer diameter and a base curve of 8.9mm.
The larger diameter of PureVision®2 HD For
Astigmatism offers more area to spread out the
ballast design to reduce the maximum thickness
In a study evaluating the orientation characteristics
and vision performance of PureVision® Toric,
an established balafilcon A toric design, and
PureVision®2 HD For Astigmatism, with advanced
aspheric optics, 20 investigators enrolled subjects
into a multi-site cross-over study.5 A total of
292 subjects completed the two week study.
Lens orientation measures indicated there was
a greater proportion of eyes with < 10° rotation
from the 6 o’clock position for PureVision®2
HD For Astigmatism at both the dispensing visit
and the two week follow up visit (p<0.05 for
both). Over all visits, there was no significant
differences between the lenses for movement,
however, the PureVision®2 HD For Astigmatism
had a greater proportion of “Excellent” ratings for
centration (p<0.05). Visual acuity was excellent
with the PureVision®2 HD For Astigmatism lens.
Subject preference favored PureVision®2 HD For
Astigmatism 2:1 over PureVision® Toric for vision
characteristics, clear vision throughout the day,
stable and consistent vision throughout the day,
clear vision in low light, clear night vision, and do
not see glare/halos with lenses (p<0.001).
Conclusion
Vision and optical expertise remain fundamental
in the development of new contact lens designs.
Patients are looking for contact lenses that offer
stable and consistent vision throughout the day
without compromising comfort. The lens design
of PureVision®2 HD For Astigmatism combines
High Definition™ Optics, Auto-Align Design™, and
ComfortMoist™ Technology to provide the clear,
crisp vision all day without compromising comfort
that patients desire.
1.Attebo K, Ivers RQ, Mitchell P. Refractive errors in an older population:
the Blue Mountains Eye Study. Ophthalmology. Jun 1999;106(6):1066‑1072.
2.Holden BA. The principles and practice of correcting astigmatism with soft
contact lenses. Aust J. Optom. 1975;58:279‑299.
3.Katz J, Tielsch JM, Sommer A. Prevalence and risk factors for refractive
errors in an adult inner city population. Invest Ophthalmol Vis Sci. Feb
1997;38(2):334‑340.
4. Consumer Toric Needs Study: US. Millward Brown.December 2010.
5.Reindel WT, Cairns G, Liranso T. Improving vision performance for astigmatic
patients through lens design. Optom Vis Sci. 2011;88:E – abstract 115803.
6
MAGAZINE
KEEPING SOFT LENSES
CONTINUOUSLY MOIST
FOR UP TO 20 HOURS
SUSAN BURKE, PHD, PRINCIPAL SCIENTIST,
BAUSCH & LOMB INCORPORATED
Difficulty in wearing soft lenses comfortably throughout
the day due to dryness symptoms is common,1, 2 and
end of day discomfort is a challenge for many patients.
Improving the wettability oflenses throughout the
lens wearing experience is a good approach to combat
dryness symptoms and improve lens wearing comfort.
Surfactant Wetting
Wetting agents (surfactants) have long been
included in virtually all MPS lens care formulations
to support the wettability of soft lenses. The wetting
agent surfactants, such as the block co-polymers
poloxamine, poloxamer and tetronics, combat
dryness symptoms and enhance patient lenswearing experience by being attracted to the
hydrophobic areas of the lens surface, helping to
spread moisture across the entire surface area of
the lens.3 Soft lens-wearing comfort that decreases
throughout the day may be related to the loss of the
wetting agent, with dryness symptoms becoming
an issue by end-of-day. To partly address this
issue, a longer retention time of surfactants on
the lens surface may bring benefits. To that end,
in vitro studies have demonstrated that Biotrue™
multi‑purpose solution helps keep lenses moist for
up to 20 hours6 (Figure 1).
Hydration
Another component of wetting of the lens surface
is the availability of hydration. Hyaluronan (HA) is a
natural lubricant of the eye that attracts up to 1000
times its weight in water and helps draw moisture to
the lens surface.5 Biotrue™, inspired by the biology
Figure 1: Hours of continuous wetting agent release from silicone hydrogel lenses.4*
Biotrue™ helps keep lenses continuously moist for up to 20 hours7
of your eyes, is the only multi-purpose solution
in the U.S. that contains HA. The long-lasting
availability of HA on hydrogel and silicone hydrogel
lenses with Biotrue has been demonstrated by
another in vitro study showing that HA is present
for up to 20 hours6 (Figure 2).
Patient Comfort Experiences
Patients have noticed the difference made by
Biotrue in making wearing contact lenses easier on
their eyes. In a large, multi-centre clinical trial, 84%
of patients indicated that Biotrue provided them
with continuous comfort.7 In other surveys
of Biotrue users:
• 8
1% of Biotrue users agree that it makes
wearing lenses so comfortable that they
sometimes forget they are wearing contact
lenses8,
• 9
3% of patients who self-selected as having
soft lens wear-related dryness symptoms
rated overall comfort with Biotrue as good to
excellent9; 83% agreed Biotrue makes every
day easier on the eyes9,
• 9
0% of over 380 users of Biotrue rated overall
comfort good to excellent.9
The conditioning system of Biotrue™ provides the
benefit of both the surfactant wetting ability and the
outstanding water attracting (humectant) properties
of HA with silicone hydrogel and hydrogel lenses.
You can be confident that your soft lens patients will
experience exceptional comfort when using bioinspired Biotrue, since the unique combination of
continuous wetting agent release and the long-term
presence of HA helps to keep lenses continuously
moist for up to 20 hours.4,6
Figure 2: HA remains on lenses for up to 20 hours.6
100
RevitaLens
OcuTec†
4
OPTI-FREE
RepleniSH
4
OPTI-FREE
PureMoist***
% hyaluronan remaining on lenses
4
Clear Care**
6
Biotrue
20
0
5
10
15
Silicone hydrogel lenses
Hydrogel lenses
80
60
40
20
0
Initial
20
5
hours
10
hours
15
hours
20
hours
Time (Hours)
*
**
***
†
Balafilcon A, senofilcon A, and lotrafilcon B.
Outside of the USA, Clear Care is marketed as AOSept Plus.
Outside of the USA, OPTI-FREE PureMoist is marketed as OPTI-FREE EverMoist.
Outside of the USA, RevitaLens OcuTect is marketed as Complete RevitaLans.
References
1. Needs, Symptoms, Incidence, Global Eye
Health Trends (NSIGHT) Study. Market Probe
Europe. December 2009. 2. The 2009
Study of the Consumer Contact Lens Market.
Multi-Sponsor Surveys. September 2009. 3.
Surfactants and interfacial phenomena, Rosen,
MJ John Wiley & Sons, Inc.: 1978. 4. Scheuer
CA, Doly K, Liranso T, Burke SE Wetting
agent retention and release from hydrogel
and silicone hydrogel contact lenses. Invest
Ophthalmol Vis Sci 2011 ;52: ARVO E-Abstract
6487. 5. Rah MJ. A review of hyaluronan and
its ophthalmic applications. Optometry. 2011
Jan;82(1):3843. 6. Scheuer CA, Fridman KM,
Bamiak VL, Burke SE, Venkatesh S Retention
of condioning agent hyaluronan on hydrogel
contact lenses. Contact Lens & Anterior Eye
2010, 33(1S), 2–6. 7. Results from a clinical trial
in which a total of 291 subjects were enrolled
across 15 investigative sites, wearing a range of
marketed soft contact lenses and using various
soft contact lens care products. Subjects were
dispensed Biotrue and participated in CAWI
(Computer Aided Web Interviewing) between
day 7 and day 11 of the clinical trial. Subject
responses were measured using a six-point
Likert Scale in which 1 = strongly disagree
and 6 = strongly agree. Results represent
reported percentage agreement. 8. Consumer
Preference Study (Dec 2010) conducted by
Bruno and Ridgeway among 201 consumers
who have tried Biotrue. 9. Results from a survey
questionnaire in which 389 users (and 20 eye
care practitioners) of various multi-purpose
contact lens solutions, including OPTI-FREE,
Clear Care, and ReNu products, used Biotrue
multi-purpose solution for two weeks and
reported their experiences. Among 237 patients
self identified as having dry eye symptoms.
Among the group were 237 patients self
identified as having dry eye symptoms. Subject
responses were measured using Likert Scales.
7
FOCUS ON
GLAUCOMA
BY SASKIA AGUADO
Glaucoma is a group of diseases of varied aetiology that damage the optic nerve,
and can result in loss of vision. Often asymptomatic, glaucoma can remain undiagnosed
with slowly progressive loss of peripheral vision. The target cells in glaucoma are
the retinal ganglion cells and their axons which constitute the optic nerve.
According to the World Health Organization
(WHO), glaucoma is the leading cause of
preventable irreversible blindness worldwide.
Roughly 70 million of the world’s population are
affected by glaucoma, and epidemiological studies
suggest that up to 50 percent of cases may go
undiagnosed. Population studies indicate that
around 10 per cent of patients diagnosed with
glaucoma will go blind bilaterally and 20 percent
will go blind unilaterally after 20 years.
There are a variety of glaucomas, most of which
may remain asymptomatic until the late stages.
The most common form of glaucoma is primary
open angle glaucoma. Early detection is the key to
limiting damage from this insidious, painless cause
of vision loss.
While there are a number of risk factors for vision
loss from glaucoma, the primary one is elevated
eye pressure also known as intraocular pressure
(IOP). In healthy adults IOP ranges from about
10 to 20 mm Hg (16 mm Hg ± 2.5). Elevated IOP
occurs when aqueous humour (clear fluid inside
the eye) that is necessary for intraocular nutrition,
fails to drain properly through the anterior chamber
8
MAGAZINE
use for the longest time and appears to be better
tolerated with a lower rate of adverse effects when
compared with the other hypotensive drugs as
well as other agents in the same class such as
bimatoprost.
angle (where de cornea and iris meet) leaving
the eye. When this situation is sustained, it may
cause a cascade of events that leads to damage to
the optic nerve. There are cases, however, where
elevated IOP is tolerated and no damage occurs.
This condition is referred to as ocular hypertension.
With Normal or Low Tension Glaucoma, the
converse may be true and a “normal” IOP may
result in damage to the optic nerve.
Latanoprost Efficacy
The average IOP drop from baseline in patients on
latanoprost 0.005% therapy ranges from 28–31%
(meta-analysis of randomized clinical trials)
at trough and peak moments.
Other risk factors for glaucoma, apart from
elevated IOP, include age, race, genetic factors,
chronic corticosteroid use, and eye conditions
such as ocular trauma or inflammation. African
Americans have been shown to be at risk at
an earlier age than Caucasians, for example.
Individuals with a family history are at increased
risk, especially when they are over 60 years of age
or have a sibling diagnosed with glaucoma. Other
factors that may represent risks are medical or
physical conditions, including diabetes mellitus or
vascular conditions such as migraine or vasospastic
dysregulation.
Maximal IOP reduction is observed for 12 hours
after drug administration, and the IOP remains
below the pre-treatment level for at least 24 hours.
Side-effects
Prostaglandin analogs have a few common side
effects, including stinging and burning when put in
the eye, darkening of the eye due to an increase of
pigmentation in the iris, and lengthening and curling
of the eyelashes. The drug generally produces
no adverse pulmonary or cardiovascular sideeffects and has not been shown to affect ocular
hemodynamics.
Currently, all treatments for glaucoma are aimed at
reducing IOP. The results of several large studies
indicate that reducing IOP in patients with ocular
hypertension and glaucoma significantly reduced
the risk of glaucomatous changes to the optic nerve
or changes in the visual field.
The goal in glaucoma management is to achieve
and maintain an intraocular pressure within the
target range considered to be “safe” for each
patient individually. The management of ocular
hypertension and glaucoma involves frequent
monitoring and adjusting therapy over the patient’s
lifetime to ensure the IOP remains at acceptable
levels in an effort to limit optic nerve damage.
There is no cure for glaucoma but it can be
managed in two ways: medication and surgery.
Both treatments manage the disease by lowering
the intraocular pressure.
Medical therapy is the most common method
used for the reduction of the IOP associated with
ocular hypertension and open-angle glaucoma.
Several classes of drugs (prostaglandin analogs,
beta-adrenergic antagonists, carbonic anhydrase
inhibitors, adrenergic agonists and cholinergic
agonists) may be used to reduce the IOP.
Medications are often compared based upon
several features: efficacy, safety, tolerability, cost
and patient acceptance. In an ideal situation, the
clinician would like to select an agent that shows
excellent efficacy and persistency, as well as being
safe and well-tolerated.
Patient Compliance and Persistence
Credit: José María Martínez de la Casa
prostaglandin analogues were all evaluated with
limited success. In general, side-effects were
significant and efficacy was low.
A breakthrough came with the development of the
prostaglandin analogue PhXA34. This compound
was produced by modification of the PGF-2 alpha
molecule. A phenyl group was added at position
17 and the double bond at C 13-14 reduced. These
changes affected potency as well as reducing
side-effects. This molecule went on to become
latanoprost (Xalatan). Since the release of Xalatan,
three additional analogues have been approved:
bimatoprost, travoprost and tafluprost.
PG analogues are effective in IOP reduction and
have a convenient once-daily dosing schedule.
Among the PG analogues latanoprost has been in
Although the preferred practice pattern of the
American Academy of Ophthalmology lists
medical therapy, laser trabeculoplasty, and
surgical treatment as reasonable options for
the initial treatment of glaucoma, most patients
initially receive topical ocular hypotensive agents.
If topical treatment lowers IOP adequately, the
patient remains on therapy indefinitely with regular
follow up to monitor the health of the optic nerve.
Although recent studies clearly have documented
that the lowering of IOP decreases the risk of
visual field loss and slows progression from ocular
hypertension to glaucoma, lack of compliance
with topical hypotensives is major challenge in
glaucoma management.
The ease of use accompanying the once daily
dosing regimen for prostaglandins, lack of
systemic side-effects and high efficacy are all
factors that help improve compliance. Rahman et
al. reported the persistence of glaucoma medical
therapy in a database of 1006 patients with
ocular hypertension, normal tension glaucoma
and primary open-angle glaucoma attending the
Glaucoma Clinic at Glasgow Royal Infirmary,
Glasgow, UK, and determined that the introduction
of the first prostaglandin analogue, latanoprost,
dramatically improved treatment persistence for
glaucoma patients.
PROSTAGLANDIN ANALOGS
Prostaglandin analogs, such as latanoprost
0.005%, are the most effective drugs at lowering
IOP and can be considered as first line medical
therapy unless other considerations such as cost,
side effects or intolerance preclude this.
The first clinical study of the use of prostaglandins
to reduce IOP was performed by Camras using
the compound prostaglandin PGF-2 alpha. It
produced a limited reduction in IOP with significant
side-effects that included conjunctival hyperemia,
foreign body sensation and headache. Other
• Q
uigley HA. Number of people with glaucoma worldwide. BrJ Ophthalmol 1996; 80: 389–393)
• van der Valk R, et al. Intraocular pressure – lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology.
2005;112:1177–1185.
• Camras CB, Bito LZ. Reduction of intraocular pressure in normal and glaucomatous primate (Aotus trivirgatus) eyes by topically applied prostaglandin F2 alpha.Curr Eye
Res. 1981;1:205–209
• Johan Wilhelm Stjernschantz. From PGF2a-Isopropyl Ester to Latanoprost: A Review of the Development of Xalatan. The Proctor Lecture. IOVS, May 2001, Vol. 42, No. 6
• The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J
Ophthalmol 2000; 130: 429–40
• Denis P, Baudouin C, Bron A, et al. First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial
intraocular pressure. BMC Ophthalmol 2010; 10: 4.
• Nordstrom BL, et al. Persistence and Adherence With Topical Glaucoma Therapy. Am J Ophthalmol 2005;140:598–606.
• Rahman MQ, Abeysinghe SS, Kelly S, et al. Persistence of glaucoma medical therapy in the Glasgow Glaucoma Database. Br J Ophthalmol 2011 (epub ahead of print).
• Reardon G, Schwartz GF, Mozaffari E. Patient persistency with pharmacotherapy in the management of glaucoma. Eur J Ophthalmol 2003; 13(Suppl 4): S44–52.
22
24-hour coverage for chronic dry eye
n For chronic
tear dysfunction
n Long-lasting relief
with no blurring effect1
Artelac® Rebalance and
Artelac® Nighttime Gel
Specifically formulated to keep eyes
hydrated and comfortable — day and night
Reference: 1. Data on file (Vitadrop [K5] [ophthalmic solution] scientific profile),
Bausch & Lomb Incorporated
Artelac Nighttime Gel
®
n Unique three-layer action provides hydration
and seals in moisture
n Mixes quickly with natural tears
See better. Live better.
Learn more at: www.artelac.co.uk
Contact your local wholesaler to order Artelac products today!
UK/ART/12/002 February 2012
225006_Artelac_Ad.indd 1
24/04/2012 10:15
10
MAGAZINE
ENVISTA
JUST SAY ‘NO’ TO GLISTENINGS
11
As the first hydrophobic acrylic IOL from Bausch + Lomb, the enVista lens represents
a significant step forward in IOL technology. Setting the enVista apart from currently
available IOLs is the unique combination of aspheric, aberration-free Advanced Optics
technology, designed to deliver enhanced contrast sensitivity and better quality of
vision, with a clinically proven glistening-free material. In addition, the enVista lens
design is intended to minimise posterior capsular opacification (PCO), a common
long-term problem with IOLs that can cause a patient’s vision to become clouded postsurgery. These features, combined into one platform with the enVista lens, provide
surgeons with the opportunity to optimise short-term and long-term outcomes for
their patients.1-3
LENS MATERIAL
Glistening-Free
Glistenings are fluid-filled microvacuoles that
can form within an IOL, and are common in most
hydrophobic acrylic IOLs, especially AcrySof4.
They cause a portion of the light coming into the
eye to be scattered in all directions, and have
been shown to have a negative impact on
visual acuity.4 In a recent survey by IPSOS
Health, glistening-free was ranked as one of
the top features that differentiates enVista from
other IOLs by surgeons currently using other
hydrophobic IOLs.5
enVista is made from a unique glistening-free
material. Pre-hydration to equilibrium in 0.9%
saline, eliminates the propensity for water
absorption, so it will neither gain nor lose aqueous
when implanted in the capsular bag.6-8 The lens is
then packaged in a physiological saline solution to
maintain its hydration and to inhibit formation of
glistenings.6–8 Not only are glistenings prevented,
but the material’s stability is believed to be
enhanced by hydrating the lens to equilibrium.6–8
“We are proud to innovate the hydrophobic lens
category with an IOL that provides a high quality
of vision and addresses the common issue of
glistenings. It was important that we deliver an
advanced hydrophobic lens that surgeons and
patients can count on now and over the long-term,
and data shows that we have achieved that with
the enVista lens.”Spokesperson,
Bausch + Lomb Surgical
Hydrophobic
The enVista polymer is formed from a
combination of hydroxyethyl methacrylate
(HEMA) and a polyethylene glycol phenylether
acrylate styrene copolymer. The cross linking of
these two polymers with a 3rd ethylene glycol
dimethacrylate form the lens material for enVista,
which is not only biocompatible but also has a
high refractive index (1.54). The enVista material
is hydrophobic in nature, and its contact angle
is greater than that of the AcrySof material,
meaning its surface is even more hydrophobic
than AcrySof 6.
Highly Durable
The enVista material offers a more durable optical
surface for resistance to abrasion and wear
during insertion which helps keep enVista free of
permanent surface marks. The enVista material
also has minimised silicone oil adhesion of less
than 5% — a major advantage for vitreoretinal
surgeons. Silicone oil adhesion can be as high
as 35% in other commercially available
hydrophobic IOLs.9
LENS DESIGN
Designed to
Minimise PCO
Low incidence of PCO
is a critical requirement
for IOL selection and
one of the main reasons
for choosing an IOL.5
enVista is designed to
minimise PCO by reducing
the radius of curvature
between the lens edge and the
optical surface of the lens, providing for a
very sharp square edge. It is important to note that
not all lenses are produced in this way and this is
one of the most important factors in preventing
PCO.10 Differences in the posterior optic edge
profile may explain why some IOLs have higher
PCO rates and why some IOLs appear to
perform better. enVista has a radius of curvature
of 8µm giving it a high quality square edge, this
is comparable to other hydrophobic acrylic IOLs
with good PCO performance. 10
The enVista lens has a full 360° sharp square
posterior edge, step-vaulted haptics which are
designed to vault the optic posteriorly, to ensure
direct contact with the capsular bag and prevent
LEC migration. The fenestration holes at the base
of the haptics are designed to evenly transmit forces
to the optic, promoting even pressure on the 360°
square barrier edge.
“The enVista hydrophobic lens has been clinically
demonstrated to be free of glistenings, a key attribute
to help improve visual acuity,” said Professor
David Spalton, FRCS, FRCP, FRCOphth,
St. Thomas Hospital, London. “Its 360°
square-edge barrier also provides an
effecti e optic-haptic junction, which
is associated with a low incidence
of PCO.”
Advanced Optics
Standard spherical intraocular
lenses have inherent positive
spherical aberration, in which
the refracting power of the lens
increases from center to edge. This
results in degradation in retinal image
quality, causing a loss in contrast sensitivity.
Pseudophakic eyes with standard IOLs have more
positive spherical aberration than phakic eyes
of the same age. In the younger population, the
negative spherical aberration of the crystalline lens
partially compensates for the positive spherical
aberration of the cornea. However, with age, this
partial compensation is gradually lost, leading to
an increase in positive spherical aberration11–14.
Implanting a spherical IOL adds to the already
positive spherical aberration of the cornea and can
impair the visual outcome with a loss of contrast
sensitivity in low light conditions.
Aspheric lenses with negative spherical aberration
are designed to compensate for the average
amount of positive spherical aberration in the
cornea. Intuitively this strategy makes sense, but
HYDROPHOBICITY
In chemistry, hydrophobicity (from the combining form of water
in Attic Greek hydro and for fear phobos) is the physical property
of a molecule (known as a hydrophobe) that is repelled from a
mass of water.
Hydrophobic molecules tend to be non-polar and thus prefer other
neutral molecules and non-polar solvents. Hydrophobic molecules
in water often cluster together, forming micelles. Water on
hydrophobic surfaces will exhibit a high contact angle.
12
MAGAZINE
can cause problems as every patient has a unique
optical system. Aspheric lenses with negative
spherical aberration can potentially cause visual
impairment, if ocular misalignment occurs, leading
to higher order aberrations, such as coma.15
These lenses have also been designed for an
average of corneal profiles, and may not be
appropriate for patients, whose corneas deviate
from the average cornea.
Bausch + Lomb’s Advanced Optics technology,
which exists on the entire lens portfolio, has
aspheric anterior and posterior surfaces that
do not induce positive or negative spherical
aberration. The lenses are neutral to the cornea,
making them suitable for all patients regardless
of corneal shape. Based on published studies, this
leaves the eye with its natural degree of corneal
positive spherical aberration, with improved
contrast sensitivity, but still providing patients
with a good depth of field.16
“This lens has other optical advantages. Its optic is
aberration-free which means it does not increase
the optical aberrations of the cornea which is
especially useful in eyes already operated for
refractive corneal surgery.” Roberto Bellucci,
Director Ophthalmic Unit, Hospital of
Verona, Italy
Predictable Refractive Outcomes
A lens is said to be decentred if it is not aligned
with the visual axis. Independent studies
have shown that 33% of all IOLs decentre
by approximately 0.5mm from the pupil.
True decentration of an IOL is probably even
greater than reported, as the visual axis doesn’t
pass through the centre of the pupil.17
enVista has a uniform power from the centreto-edge, which means that it is not impacted by
decentration. Lenses which do not have a uniform
power may provide poorer outcomes if they are
subject to decentration or tilt.
LENS DELIVERY
Single use inserter
There has been a clear trend in recent years
towards the increasing adoption of single-use
instruments. 72% of surgeons now use single
use instruments, which is an increase from
55% in 2008.18
This lens has other optical advantages. Its optic
is aberration-free which means it does not
increase the optical aberrations of the cornea
which is especially useful in eyes already
operated for refractive corneal surgery.
ROBERTO BELLUCCI
“The advantages of having single-use inserter are
probably threefold. Firstly, if you have an injector of
this type it means that you don’t have to worry about
the possibility of infection related to a multi-use
injector. Secondly, the injector will always be the
same and therefore injection will be completely
repeatable, and thirdly because you don’t have
to sterilise a multi-use injector, there could be
significant ost savings.” Mr Richard Packard,
Prince Charles Eye Unit, King
Edward VII Hospital Windsor.
2.2mm Implantation
2.2mm has become the industry standard for
hydrophobic IOL incision size with many cataract
surgeons working or wanting to work at 2.2mm
The flexibility of the enVista material enables
you to insert it easily through a 2.2mm incision
with more controlled unfolding than current
hydrophobic acrylic IOLs, facilitating precise lens
placement and removal of the viscoelastic at the
end of the procedure.
Amvisc Plus by Bausch + Lomb is a viscoelastic
that performs effectively throughout the entire
procedure. It has the perfect balance in one
syringe with unique lasting chamber retention and
efficient removal. Amvisc Plus is efficient in small
incision surgery due to its dynamic viscosity
and excellent transparency.
Bausch + Lomb also offers a wide range of
single use instruments for MICS surgery.
Capsule Guard I/A has a unique design for
advanced capsule cleaning. These single use,
silicone-tipped, irrigation/aspiration hand pieces
protect the capsule during the entire procedure.
Smooth ports designed to reduce the risk of
capsular rupture and the adhesive properties of
the silicone tip allow for effective and efficient
cortical removal.
CONCLUSION
The enVista hydrophobic acrylic intraocular lens
is a significant addition to the surgeon’s current
armamentarium. The enVista lens features a
highly durable, clinically proven glistening-free
material with a lens design developed to minimise
posterior capsular opacification. The unique
material combined with the aspheric, aberrationfree Advanced Optics technology, provides
surgeons with a new lens platform for optimal
patient outcomes.
References
1.Pepose JS, Qazi MA, Edwards KH,
Sanderson JP, Sarver EJ. Comparison
of contrast sensitivity, depth of field and
ocular wavefront aberrations in eyes with
an IOL with zero versus positive spherical
aberration. Graefes Arch Clin Exp
Ophthalmol. 2009;247(7):965–973.
2.Johansson B, Sundelin S, Wikberg-Matsson
A, Unsbo P, Behndig A. Visual and optical
performance of the Akreos® Adapt
Advanced Optics and Tecnis Z9000
intraocular lenses: Swedish multicenter study.
J Cataract Refract Surg. 2007;33(9):
1565–1572.
3.Nishi O, Nishi K, Osakabe Y. Effect of
intraocular lenses on preventing posterior
capsule opacification: design versus material.
J Cataract Refract Surg. 2004;30(10):
2170–2176
4.Christiansen G, et al. Glistenings in the
AcrySof intraocular lens: pilot study.
J Cataract Refract Surg. 2001;27:728–33
5.Bausch + Lomb commissioned IPSOS
Health to research 182 randomly selected
surgeons – all hydrophobic users. Research
carried out October – December 2010
in Spain (n=58), Germany (n=66) & UK
(n=58). 27 surgeons participated in focus
groups or depth interviews. 155 surgeons
completed a 30 minuite online survey
that was designed and managed by
IPSOS health.
6.Mentak P, Elachchabi A, Goldberg E.
Hydrophobic character and aqueous
wetability of hydrophobic IOLs. Paper
presented at the XXVI Congress of the
European Society of Cataract and Refractive
Surgery; September 13-17, 2008;
Berlin, Germany.
7.Mentak P, Elachchabi A, Martin P, Goldberg
E, Mentak A. Nanoindentation studies on
hydrophobic acrylic IOLs to evaluate surface
mechanical properties. Paper presented
at the XXV Congress of the European
Society of Cataract and Refractive Surgery;
September 8-9, 2007; Stockholm, Sweden.
8.Data on File, Bausch and Lomb. Final Clinical
Study Report: A prospective multicenter
clinical study to evaluate the safety and
effectiveness of a Bausch + Lomb one-piece
hydrophobic intraocular lens in subjects
undergoing cataract extraction.
9.Mentak, K – A new family of high refractive
index polymers for IOL and refractive
implant applications. Data on file
Bausch + Lomb
10.Spalton D, Dhital A, Boyce J. n Evaluation
of a new hydrophobic acrylic IOL. Poster
presented at the XXVIII Congress of the
European Society of Cataract and
Refractive Surgery, 2011 Vienna
11.Behndig A, Lundström L, Unsbo P. Aspheric
Intraocular Lenses: Mastering the techniques
of advanced phaco surgery, Eds. Garg, A;
Fine, H; Chang, D, et al., Jaypee Brothers
Medical Publishers, Ltd. 2008, ISBN 97881-8448-203-4.
12.Alió JL, Schimchak P, Negri HP, MontesMico, R. Crystalline lens dysfunction through
aging. Ophthalmology 2005; 112: 2022-9.
13.Artal P, Benito A, Tabernero J. The human
eye is an example of robust optical design.
J Vis 2006; 6: 1–7.
14.Guirao A, Gonzalez C, Redondo M,
Geraghty E, Norrby S, Artal P. Average
oprical performance of the human eye as a
function of age in normal phakic population.
Invest Ophthalmol Vis Sci 1999; 40:
203–13.
15.Altmann GE, Nichamin LD, Lane SS, Pepose
JS. Optical performance of 3 intraocular lens
designs in the presence of decentration. J
Cataract Refract Surg 2005; 31:574–585
16.Nio Y-K, Jansonius NM, Geraghty E, et
al. Effect of intraocular lens implantation
on visual acuity, contrast sensitivity, and
depth of field. J Cataract Refract Surg.
203;29(11):2073–81
17.Koch D, Wang L. Effect of decentration of
wavefront-guided IOLs on the higher order
aberrations of the eye, presented at the
XXII Congress of the European Congress
of Cataract and Refractive Surgeons,
September 2004
18.Bausch + Lomb commissioned Milward
Brown Health to research 500 cataract
surgeons across 5 markets – Spain, UK,
France, Germany and Italy. Research
carried out in March – April 2011. Surgeons
completed a 25 minute online survey –
managed and analysed by Milward Brown.
13
BAUSCH + LOMB AND TECHNOLAS™ PERFECT VISION ANNOUNCE
CE MARK APPROVAL FOR
™
VICTUS FEMTOSECOND
LASER PLATFORM
First Single-Platform Femtosecond Laser Now
Commercially Available in European Union
In December 2011, Bausch + Lomb, the global
leader in eye health, and Technolas™ Perfect Vision
GmbH (TPV), a leading ophthalmology laser
company, announced the commercial availability
of the VICTUS™ Femtosecond Laser Platform in
the European Union (EU). After securing CE mark
approval, the VICTUS platform is approved for
LASIK flap, astigmatic keratotomy, INTRACOR,
capsulotomy and lens fragmentation.
“This is a significant miles one for Bausch + Lomb
that will deliver breakthrough capabilities to our
eye care professionals and the patients they serve,”
said Brent Saunders, Chief Executive Officer of
Bausch + Lomb.
The VICTUS platform is uniquely designed
to support cataract, refractive and therapeutic
procedures all on a single platform. The
femtosecond laser technology enables greater
precision in both cataract and refractive procedures
compared to manual techniques, giving
ophthalmologists more control and potentially
enhancing the patient experience.
“This CE mark approval represents a major step
for femtosecond laser technology by elevating the
role that laser technology can play in refractive and
cataract procedures,” said a Spokesperson from
Bausch + Lomb. “I am excited that we will begin
shipping product by the end of the year.”
As previously announced, Bausch + Lomb and
TPV will promote the VICTUS platform globally,
leveraging their combined cataract and refractive
expertise and commercial capabilities. The two
organizations are also working with regulatory
authorities around the world to secure additional
marketing approvals for the platform.
“Our focus has been to empower ophthalmic
surgeons with the latest advances in laser
technology in order to potentially provide patients
with better outcomes and quality of life,” said
Kristian Hohla, PhD, chief executive officer of
Technolas Perfect Vision. “We are very pleased
that, together with Bausch + Lomb, we have
demonstrated the viability of the VICTUS platform
for enhanced cataract surgery.”
The VICTUS platform as well as early clinical
data was presented at the 2011 European Society
of Cataract and Refractive Surgeons (ESCRS)
Congress in Vienna, the American Academy
of Ophthalmology (AAO) Annual Meeting in
Orlando and at the Asia-Pacific Association of
Cataract and Refractive Surgeons (APACRS) in
Seoul earlier this year. Plans to submit the data for
publication in peer-reviewed journals are underway.
About Femtosecond Lasers
Femtosecond lasers emit optical pulses of
extremely short duration in the domain of
femtoseconds, as short as one-quadrillionth of
a second. With these ultra-short pulses, tissue
can be cut more precisely and with practically
no heat development.
“This is a significant
milestone for Bausch
+ Lomb that will
deliver breakthrough
capabilities to our eye
care professionals and
the patients they serve”
14
MAGAZINE
THE SCIENCE OF PRESERVATIVEASSOCIATED TRANSIENT
HYPERFLUORESCENCE (PATH)
To discuss the science of fluorescein, corneal staining, and preservative-associated
transient hyperfluorescence (PATH), some of the preeminent research experts in
the study of fluorescence spectroscopy and corneal staining from around the world
(Drs. Paul Karpecki, Frank Bright, Nathan Efron, and Philip Morgan) gathered to share
their new research and personal opinions on these topics. The following is a summary
of the key messages from this meeting.
15
Figure 2 (below and
right): Fluorescein
(negative charge) and MPS
preservatives (positive
charge) are attracted to one
another. The level of attraction
depends on the MSP
preservative.
Figure 1 (left): Adsorbed
MPS preservative are
released by the lens into the
tear film upon application
onto the eye. The release
rate is dependent on the
preservative and lens material
combination. Released
preservatives are dissipated
by normal tear flow.
FLUORESCEIN
First synthesized in 1871, fluorescein is a molecule
not found in nature. Many factors can impact
the fluorescent intensity and diagnostic utility
of fluorescein. First, the charge of fluorescein is
directly related to the pH of the environment and its
fluorescence is highly pH dependent (fluorescence
intensity increases as pH rises until a pH of 8 is
reached). Also, at high concentrations (>0.001%)
it is self-quenching (energy emitted by fluorescein
molecules is absorbed by nearby fluorescein
molecules rather than being emitted as light), so
diminished fluorescence occurs with increasing
concentration above this threshold.
Preservative Uptake and Release
All multi-purpose solutions (MPS) contain
one or more preservative agents such as
polyhexamethylene biguanide (PHMB),
polyquaternium-1 (PQ-1), myristamidopropyl
dimethylamine (MAPD; also known as Aldox),
and alexidine. The total amount of preservative
contained in MPS formulations is very small,
ranging from 1 to 15 parts per million. Although
MPS preservatives are taken up by soft contact
lenses while soaking, the amount adsorbed may
be too low to quantify.
A number of factors can influence the uptake of
preservative into a soft contact lens including: the
soft contact lens material, type(s) of preservative
contained in the MPS, and overall MPS formulation
including components such as buffers, wetting
agents, or other molecules that carry an electrostatic charge. The amount and rate of uptake for
each preservative can vary between hydrogel and
silicone hydrogel lenses, as well as among the
different silicone hydrogel lens materials.
When placed on the eye, the soft contact lens
begins to release the adsorbed preservative
into the tear film. The rate at which this occurs
is dependent on the preservative and type of
contact lens material. The preservative is ultimately
dissipated through the normal turnover of tear film
(Figure 1).
Fluorescein and Preservative
Interactions
Corneal Staining vs. MPS-Associated
Hyperfluorescence
The MPS preservatives released from soft
contact lenses interact with fluorescein dye when
it is applied to the eye. Fluorescein is negatively
charged and MPS preservatives are positively
charged, attracting them to one another (Figure
2). The level of attraction depends on the MPS
preservative. Dr. Bright’s studies have found that the
attraction between fluorescein and the preservative
polyhexamethylene biguanide (PHMB) is up to
fifty times greater than the attraction between
fluorescein and the preservative polyquaternium-1
(PQ-1). The substantially higher affinity of
fluorescein for PHMB may account for the higher
levels of hyperfluorescence at a 2-hour time point
with PHMB-based solutions versus MPS with other
preservatives at all time points.
Although a number of eye care professionals
(ECPs) have labeled this phenomenon as “corneal
staining”, many characteristics of PATH point to it
being a distinct entity from corneal staining. One
such difference is the etiology of PATH versus
corneal staining. While the etiology of PATH is
due to the benign preservative interaction with
fluorescein, pathological corneal staining is due
to damage to the epithelium. Additionally, PATH
is generally asymptomatic, has a superficial
punctate pattern, and is transient, lasting only
several hours following lens insertion, and is not
associated with future complications (Figure 3).
These characteristics, especially together, are
not observed in cases of corneal staining during
pathological situations.
Figure 3: The binding of PHMB and fluorescein results in a benign, transient hyperfluorescence.
The most intense hyperfluorescence it produced during the time of peak PHMB release.
PHMB Concentration (μg/μL)
Understanding Fluorescein
PRESERVATIVE
0.014
0.012
0.010
0.008
0.006
0.004
0.002
0
0
2
4
6
8
10
12
14
Time (hours)
CONCLUSION
While a significant effort has been made to connect PATH with adverse outcomes over the past
decade, to date, no negative sequelae have been shown to be associated with PATH. A large
body of literature shows the hyperfluorescence at the time of peak PATH is not pathological
corneal staining, a measure of biocompatibility, a cause of infiltrative keratitis or infection,
an indicator of cellular damage, or associated with future adverse events. It is essential that
clinicians understand what they are observing in patients and why. It is only then the best clinical
decisions for patient’s health and satisfaction can be made.
16
BAUSCH + LOMB INSTRUMENTS
MADE IN
GERMANY
BY HORST VOLLMERHAUSEN, PLANT MANAGER
MAGAZINE
Surgical handheld
instruments are key tools
for every surgeon when
performing surgery.
The functionality and
quality of an instrument
are key elements for
achieving the best
outcomes in eye surgery.
How an instrument fits into a surgeon’s hand and
how easily it can be handled are aspects that have
direct impact on performance. Cleaning and
re‑sterilisation are important features for nurses
and administration people.
Bausch + Lomb instruments crafted in
Heidelberg Manufacturing are designed and
produced to optimally meet customers’ expectations.
Close to 100 people in Heidelberg Manufacturing
have longstanding experience in developing and
producing high quality stainless steel reusable
instruments and single-use surgical instruments.
Heidelberg experience dates back to as early as
1947 when Leonhard Klein started his own company in
Heidelberg. Leonhard Klein’s business was continued
by Storz Ophthalmics which, today, is the basis and an
important part of Bausch + Lomb’s Surgical business.
Specific designs for reusable instruments and
their size allow them to be crafted by experts only.
Our experts – called “Chirurgiemechaniker” – are
going through a thourough and very well established
training programme of approx. 3 ½ years before they
have obtained the necessary skills and qualification
to become “Chirurgiemechaniker”. It takes even
longer to become a master craftsman in the field of
“Chirurgiemechanik”. Such intense education and
training combined with longstanding experience
are the keys to achieving an excellent level of quality
and functionality in instruments which are very well
accepted by surgeons.
17
During the past years, upcoming surgical trends –
such as smaller incisions (MICS < 2mm incision),
increased hygiene guidelines for surgical rooms,
expectations for simplifying surgical procedures –
have led to the development and production of
single-use instruments. Bausch + Lomb Heidelberg
subsequently expanded their product portfolio,
and now offer a wide range of single-use instruments
for cataract and vitreoretinal surgery, which are
“Made in Germany”. The overall process from design
and development – performed in cooperation with
key surgeons and highly experienced craftsmen –
to production in our Heidelberg plant are the
guarantee for offering and supplying high-end
products to our customers.
A breakthrough design for irrigation and aspiration
handpieces was the development of the Capsule
Guard® I/A line with a soft tip made out of silicone.
No metal touches the
membrane or comes
into contact with
ocular tissue. This
handpiece design
offers excellent
handling properties
for use inside the
eye and a fully
sealed wound.
A manufacturing
tour for nurses
and surgeons is
part of our wetlab
trainings which
take place all
year round.
Unique design for
advanced capsule cleaning
These single use silicone I/A handpieces protect the capsule
during the entire procedure. Smooth ports are designed
to reduce the risk of capsule rupture and the adhesive
properties of the silicone tip allow for effective and efficient
cortical removal.
Available for 1.8mm MICS and standard incisions.
SINGLE USE
CATALOGUE
PER PROCEDURE KITS
INSTRUMENTATION
CORNEAL TRANSPLANT
CATARACT PROCEDURES
VITREORETINAL PROCE
DURES
INTRAOCULAR LENSE
S
VISCOELASTICS
ACCESSORIES
Safety. Consistency. Convenience.
www.storzeye.eu
© Bausch & Lomb Incorporated. ™/® denote trademark of Bausch & Lomb Incorporated.
www.storzeye.eu
18
MAGAZINE
A NEW, MODERN TOOL FOR
MANAGING POST-CATARACT
INFLAMMATION
BY MOHAMMAD AL-ADDAI
Recent advances in cataract surgery techniques,
smaller incisions and foldable intraocular lens design
have led to improved outcomes and decreased the
resulting trauma. Nevertheless, ocular inflammation
may develop and can cause patient discomfort, delay
postoperative recovery, and may lead to additional
complications. [Wittpenn 2008, Silverstein 2011]
It is believed that the stress of ocular surgery
initiates a cascade of inflammatory events that can
lead to a breakdown of the blood-retinal barrier and
the accumulation of intra-retinal fluid. Signs and
symptoms of macular thickening typically develop four
to six weeks postoperatively, resulting in temporary
or, in some cases, permanent loss of best-corrected
visual acuity (BCVA).[Wittpenn 2008]
Overview of post-operative
ocular inflammation
Inflammation is the manifestation of cellular and
vascular response of the host tissue to injury.
Injury to the tissue may be inflicted by physical
or chemical agents, pathogens, ischemia, and
excessive (hypersensitivity) or inappropriate
(autoimmunity) operation of immune mechanisms.
Inflammation facilitates the immune response and
the subsequent removal of antigenic material and
damaged tissue.[Ahuja 2008]
Surgical trauma triggers the arachidonic acid
cascade, which in turn, generates prostaglandins
(PG) by activation of Cyclo-oxygenase (COX)
enzymes. Clinical symptoms of PG production
include hyperemia, miosis, impaired vision, pain,
and diminished visual acuity secondary to cystoid
macular edema (CME).[Cho 2009]
Two main isoforms of COX, COX-1 and COX2, have been identified. COX-1, a constitutive
enzyme, synthesizes PGs that regulate physiologic
processes. COX-2 is expressed in response to a
noxious stimulus, the induction of which leads to
the production of PGs that cause inflammation and
19
Clinical Data
NH2
OH
Br
O
Figure 1 Chemical structure of Bromfenac [Cho 2009]
pain. It has been demonstrated in rats that COX-2
is the primary mediator for ocular inflammation.
Therefore, inhibition of COX-2 is thought to be
the most important therapeutic mechanism of
ophthalmic nonsteroidal anti-inflammatory drugs
(NSAIDs). [Cho 2009, Kim 2010]
Corticosteroids interfere with the activity of
phospholipase A2, and in contrast, NSAIDs
non‑specifically and irreversibly inhibit the synthesis
of PGs by interfering with the activity of COX-1
and COX-2. [Cho 2009]
Corticosteroids are frequently used in the
management of ocular inflammation, but their antiinflammatory benefits have to be considered in the
context of the risk for serious adverse effects like:
elevation of intraocular pressure, progression of
cataracts, increased risk of infection and worsening
of stromal melting. [Ahuja 2008, Cho 2009]
Ophthalmic NSAIDs have become a cornerstone
for the management of ocular pain and
inflammation. Their established safety record, and
well characterized anti-inflammatory and analgesic
properties have also made NSAIDs an important
tool to optimize surgical outcomes.[Donnenfeld 2006]
Introducing Yellox (Bromfenac
sodium sesquihydrate): A new, modern
tool for managing post-cataract
inflammation
Bromfenac ophthalmic solution 0.1% was first
approved in May 2000 as Bronuck® (Senju
Pharmaceutical Company, Ltd., Osaka, Japan).
[Bronuck package insert, 2003]
A similar formulation was
approved in the United States by the Food and
Drug Administration (FDA) in March 2005 as
Xibrom (bromfenac ophthalmic solution 0.09%),
and in March 2011, it was approved by the FDA as
Bromday for Once Daily (QD) dosing.[Xibrom, Bromday
Prescribing Information]
Yellox (Bromfenac ophthalmic solution 0.09%)
received a pan-European Marketing Authorisation
in June 2011, and is indicated for the treatment of
postoperative inflammation in patients who have
undergone cataract extraction.
The recommended dosage of Yellox is one drop in
the affected eye(s) twice daily beginning 24 hours
after cataract surgery and continuing through the
first 2 weeks of the postoperative period. [Yellox SmPC]
Mechanism of action
Bromfenac is an NSAID that has anti-inflammatory
activity which is thought to be due to its ability to
block prostaglandin synthesis by inhibiting primarily
COX-2. COX-1 is only inhibited to a small extent.
[Yellox SmPC 2011]
The efficacy of Yellox in treating post-operative
inflammation after cataract surgery, without
pre-treatment or concomitant steroids, has been
evaluated in the USA in two phase III, doublemasked, placebo-controlled clinical trials.
Subjects enrolled had undergone unilateral cataract
extraction and posterior chamber intraocular lens
implantation and had moderate to severe ocular
inflammation (Summed Ocular Inflammation Score
[SOIS] ≥3), as assessed 16–32 hours after the
procedure. The patients were randomly assigned
to Yellox twice daily (n=356), or placebo (n=171)
for 14 days (from day 1 to day 15). The main
outcome measure was cleared ocular inflammation
(SOIS=0) after 14 days of treatment.
[Donnenfeld 2006, Donnenfeld 2007]
A pooled intent-to-treat (ITT) analysis of these
two studies was conducted, including a total of
527 patients. It revealed that significantly more
Yellox-treated (64% [228/356]) than placebo patients
(43.3% [74/171]; p<0.0001) achieved an SOIS
100
p=0.0012, §p<0.0001 vs placebo
#
59.3%
§
80
§
§
60
40
8.4%
§
26.9%
20
1.2%
0
A supplemental analysis of the data while patients
were on their assigned treatment only, excluding the
effects on any rescue medication, was conducted
(last observation carried forward [LOCF] in those
patients requiring a change in regimen). This
analysis indicated that 59.3% of Yellox-treated
patients had an SOIS of 0 versus 26.9% of those
receiving placebo (p<0.0001).
Clinical effectiveness persisted for up to 4 weeks
after 14 days’ treatment, with >80% patients having
inflammation controlled. Furthermore, significantly
more Yellox patients had marked improvement in
ocular inflammation (SOIS≤1) at day 15 compared
with placebo (85.1% vs 52.6%; p<0.0001).
[Donnenfeld 2006, Donnenfeld 2007]
Worldwide, Bromfenac has been used for more
than 10 years with more than 20 million patients
treated. [CHMP Assessment report]
The pooled safety data from the two US Phase
III trials show that overall, bromfenac ophthalmic
solution was well tolerated, with only 3.4% of
patients experiencing one or more adverse events.
In two large US phase III clinical trials, there were
fewer adverse events in the Yellox group than the
placebo group and no serious adverse events
(including ocular) considered related to Yellox.
[Donnenfeld 2006, CHMP Assessment report]
#
D3
score of 0 on day 15. It should be noted that the
ITT analysis included all patients in their assigned
group, regardless of whether they actually received
the assigned treatment. Also, the data include
the effects of any alternative anti-inflammatory
regimens administered after the start of the trial
(given, for instance, because of adverse effects or
lack of efficacy). [Donnenfeld 2006, Donnenfeld 2007]
Safety
More Yellox patients achieved ocular inflammation
control within 2 weeks: LOCF analysis
Patients with SOIS = 0 (%)
O
D8
D15
D22
D29
Adapted from Donnenfeld et al 2007. Shown are the data from the LOCF analysis (in which the
patients were assessed while on their assignment treatment). SOIS is calculated by summing the
anterior chamber cell score and flare score (each of these scores being on a scale from 0 to 4).
Figure 2 Results of two US Phase III trials, Last Observation
Carried Forward (LCOF) analysis
No systemic adverse drug reactions have been
associated with bromfenac ophthalmic solution
across the entire body of clinical and surveillance
data. In addition, liver function test values following
ophthalmic bromfenac administration found no risk
of hepatic toxicity. [Donnenfeld 2006, Donnenfeld 2007]
Ocular adverse events occuring in >2% Yellox treated patients in US phase III trials
Adverse event
Treatment groups
Yellox (n=356)
Placebo (n=171)
Iritis
7.0%
18.1%
Abnormal sensation in eye
6.5%
8.2%
Eye pain
4.2%
11.7%
Eye pruritus
3.9%
2.9%
Posterior capsular opacification
3.9%
4.1%
Eye irritation (burning/stinging)
2.5%
4.7%
Eye redness
2.2%
7.6%
Conjunctival hyperaemia
2.2%
11.1%
Photophobia
2.0%
11.1%
Macular oedema
1.4%
4.7%
Figure 3 Pooled safety data from US Phase III trials [Adapted from Donnenfeld 2006, Donnenfeld 2007]
Bromday® (previously Xibrom®),
prescribing information
Wittpenn JR et al. Am J Ophthalmol.
2008;146(4):554–60
Silverstein SM et al. Current Medical Research
& Opinion Vol. 27, No. 9, 2011, 1693–1703
Ahuja M et al. AAPS J. 2008 Jun;10(2):229–41.
Epub 2008 Apr 25
Cho H et al. Clin Ophthalmol. 2009; 3:199–210
Kim SJ et al. Surv Ophthalmol. 2010;55(2):108–33
Bronuck Package Insert 2003
Donnenfeld ED et al. Ophthalmology
2007;114(9):1653–62
Donnenfeld ED, Donnenfeld A. Int Ophthalmol Clin.
2006; 46(4):21–40
Yellox SmPC
Committee for Medicinal Products for Human Use
(CHMP) Assessment Report, 17 March 2011
UK/YEL/12/002, April 2012.
Prescribing information can be found on page 20.