Bausch + Lomb Visions Magazine Issue 12

EUROPEAN EDITION

AUTUMN 2011

BETTER VISUAL ACUITY WITH ASPHERIC OPTICS PAGE 10

4 Tear film dysfunction Artelac – Always the right solution 8 for dry eyes

Crystalens AO – Changing the 8 way you see the world

Biotrue – Bringing new inspiration to 16 lens care

Charles Kelman – Inventor 12 of Phacoemulsification

Hydrogels – Wettability with 18 Silicone different contact lens solutions

Yellox... putting a stop † to ocular inflammation fewer drops. less time.*

Yellox delivers rapid penetration and powerful resolution of ocular inflammation in less time, with highly potent and targeted prostaglandin inhibition in fewer drops, allowing unique twice daily dosing.*

Fast‡1-3 Powerful1 Convenient1,4 Well-tolerated§1,4 Yellox® (bromfenac sodium sesquihydrate) 0.9 mg/ml eye drops, solution. Prescribing Information. Please refer to the Summary of Product Characteristics before prescribing Yellox®.

Pharmaceutical form: Eye drops containing 0.9 mg/ml bromfenac (as sodium sesquihydrate) in clear yellow solution; one drop contains approximately 33 micrograms bromfenac. Indication: Treatment of postoperative ocular inflammation following cataract extraction in adults. Dosage and administration: For ocular use. Use in adults, including the elderly: The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the day after cataract surgery and continuing through the first 2 postoperative weeks. The treatment should not exceed 2 weeks as safety data beyond this is not available. Paediatric population: Safety and efficacy in paediatric patients have not been established. Hepatic or renal impairment: Safety and efficacy have not been established in patients with hepatic disease or renal impairment. Contraindications: Known hypersensitivity to bromfenac, any of the excipients, or other non-steroidal anti-inflammatory medicinal products (NSAIDs). History of asthma, urticaria or acute rhinitis precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity. Special warnings and precautions: Topical NSAIDs and corticosteroids may both slow or delay healing; their concomitant use may increase this potential. Yellox contains sodium sulphite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible patients. Cross-sensitivity: There is the potential for crosssensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, so caution is required among patients with a history of sensitivities to these medicinal products. Susceptible persons: In susceptible patients, continued use of topical NSAIDs, including Yellox, may result in potentially sight-threatening complications (epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation). Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and be closely monitored. In at-risk patients, concomitant use of ophthalmic corticosteroids with NSAIDs may increase risk of corneal adverse events. Postmarketing experience with NSAIDs: Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions. Topical NSAIDs should be used with caution in these patients. There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery.

Yellox – a new standard in ocular NSAID efficacy Yellox should therefore be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products that may prolong bleeding time. Ocular infection: An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. Excipients: Since Yellox contains benzalkonium chloride, close monitoring is required with frequent or prolonged use. Benzalkonium chloride is known to discolour soft contact lenses, and has been reported to cause eye irritation, punctuate keratopathy and/or toxic ulcerative keratopathy. Special instructions regarding drop instillation: Multiple topical ophthalmic medicinal products should be administered at least 5 minutes apart. Avoid contaminating the dropper-tip and solution, and tightly close the bottle when not in use. Contact lenses should not be worn during treatment with Yellox. Interactions: Formal interaction studies have not been performed, but no interactions with antibiotic eye drops used in conjunction with surgery have been reported. Fertility, pregnancy and lactation: Pregnancy: There are no adequate data from the use of bromfenac in pregnant women, and the potential risk for humans is unknown. In general, the use of Yellox is not recommended during pregnancy unless the benefit outweighs the potential risk. Breast-feeding: It is unknown whether bromfenac or its metabolites are excreted in human milk. The use of Yellox is in general not recommended during breastfeeding unless the benefit outweighs the potential risk. Fertility: No pregnancy testing or contraceptive measures are required. Effects on ability to drive and use machinery: Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation refrain from driving or using machines until vision is clear. Undesirable effects: In clinical trials (n = 973), a total of 3.4% of patients had ≥1 adverse reactions. The most common or most important reactions were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate, 0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%). Summary of adverse reactions: Uncommon (≥0.1% to <1%): reduced visual acuity, haemorrhagic retinopathy, corneal epithelium defect (reported with QID use, off-label use, QID), corneal erosion (mild or moderate), corneal epithelium disorder, corneal oedema, retinal exudates, eye pain, eyelid bleeding, vision blurred, photophobia , eyelid oedema, eye discharge, eye pruritus, eye irritation, eye redness, conjunctival hyperaemia, abnormal sensation in eye, ocular discomfort, epistaxis, cough, nasal sinus drainage and face swelling. Rare (≥0.01% to <0.1%; isolated reports from post-marketing experience of more than 20 million patients): corneal perforation, corneal ulcer, corneal erosion – serious, scleromalacia, corneal infiltrates, corneal disorder, corneal scar and asthma. Please consult the Summary of Product Characteristics

for a full list of side effects. Overdose: If Yellox is accidentally ingested, fluids should be taken to dilute the medicinal product. Pharmaceutical precautions: Do not store above 25°C. Legal Category: POM. Marketing Authorisation Number: EU/1/11/692/001. Marketing Authorisation Holder: Croma Pharma GmbH, Industriezeile 6, A-2100 Leobendorf, Austria.

Date of preparation: April 2011.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Bausch & Lomb UK Ltd on 01748 828864.

References 1. Yellox, Summary of Product Characteristics 2. Donnenfeld ED et al. Ophthalmology 2007; 114(9):1653-62 3. Donnenfeld ED, Donnenfeld A. Int Ophthalmol Clin. 2006; 46(4):21-40 4. Baklayan GA et al. J Ocul Pharmacol Ther. 2008; 24(4):392-8 5. Nevanac, Summary of Product Characteristics: 2009 6. Acular, Summary of Product Characteristics: 16 Feb 2010 7. Voltarol, Summary of Product Characteristics: 04 May 2010 8. Committee for Medicinal Products for Human Use (CHMP) Assessment Report, 17 March 2011 035-2011-04-BMF Date of preparation: June 2011 Yellox is a registered trademark used by Bausch & Lomb Incorporated by permission of Croma Pharma GmbH. Bausch + Lomb is a registered trademark of Bausch & Lomb Incorporated.

Yellox is licensed in all EEA member states, not in Switzerland © Bausch & Lomb Incorporated.

† Yellox is the first and only twice-daily topical ocular NSAID indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.4 In a large phase III trial, BID Yellox for 14 days controlled ocular inflammation (SOIS=0) in 59.3% of patients vs 26.9% with placebo (<0.0001).3

‡ Absorption occurs within 15 minutes, with peak aqueous humour concentration at 150–180 minutes;1,2 in a phase III, placebo-controlled trial significant clearance of ocular inflammation was as fast as 3 days in some patients (8.4% with Yellox vs 1.2% with placebo, p=0.0012), with significant efficacy persisting for 4 weeks3

*Yellox has demonstrated clinical efficacy in 2 weeks with BID dosing.

Treatment duration & dosing is relative to current clinical standards across Europe as well as older available NSAIDs.1,2,5-7

§ Millions of ophthalmic uses and very low incidence of adverse events (such as stinging and burning)1,4,8

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DEAR COLLEAGUES

B

ausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.

The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.

Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.

Over the last 150 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

Bausch + Lomb would like to welcome you to the first edition of Visions magazine for the Europe, Middle East and Africa region. The magazine includes articles and product updates from the full Bausch + Lomb portfolio. If you have any questions relating to product availability or would like to contact your local Bausch + Lomb representative you will find your local contact details listed below.

Jill Collishaw, Editor, Visions Magazine

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MAGAZINE

TEAR FILM DYSFUNCTION

BY SEBASTIANO GIUFFRIDA

In humans, the tear film coating the eye has optical, protective and trophic functions and its integrity is essential for maintaining the normal physiological balance of the eye.

In the normal eye, the ocular surface, lacrimal glands, and the neuronal loop comprise a single functional unit for the maintenance of ocular surface homeostasis.

The tear film lubricates and supports the ocular surface that, in turn, sends information which can influence tear secretion by the lacrimal glands via autonomic neural pathways.

“The ocular surface is a system in perfect balance, but as precarious as the equilibrium of the acrobat on the wire” – Prof. Maurizio Rolando, associate Professor at the Eye Clinic of the University of Genova, said during the first Bausch + Lomb Italy videoconference symposium on the treatment of tear disorders” on April 2nd, 2011.

The tear film, from the outer surface, is composed of: • Lipid layer (0.1 μm), secreted by meibomian glands, coats the aqueous layer and provides a hydrophobic barrier that prevents the evaporation of the tears. It also acts as a surfactant allowing spread of the tear film.

• Aqueous layer (7 μm), secreted by lacrimal glands, provides atmospherical oxygen to the corneal epithelium, has an antibacterial function (thanks to IgA, lysozyme and lactoferrine), allows the passage of leucocytes in case of injury, washes out debris and provides a smooth optical surface abolishing minor irregularities of the anterior corneal surface.

• Mucous layer (0.2 μm), secreted by conjunctival goblet cells, covers the cornea and allows the distribution of the tear film.

• The natural tear fluid pH is 7.1–7.4 while the osmolality is about 300 mOsmol/l. The average tear fluid is 6–10 μl and the natural turn-over of the tear fluid is 10–15 min.

Tear production varies depending on environmental conditions and the physical and emotional states and in physiological conditions and a normal environment, tear secretion is about 1 μl/min.

• Tear film dysfunction gives rise to the so called “dry eye”, a very widespread syndrome with a prevalence, in the general population, of 11–17% that increases with age as demonstrated by several epidemiological studies.

• The Dry Eye Workshop (DEWS), the reference organisation in this area, in its 2007 report defined dry eye as “a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface”.

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Dry eye is generally classified as mild, moderate or severe, majority of patients with dry eye have a mild form of the condition: • 65–89% have mild dry eye; • 12–33% have moderate dry eye; • 0–2% have severe dry eye.

ADDE is recognised to be a low volume, hyperosmolar state where there is not enough tear production. As ADDE advances, a progressive decrease in lacrimal secretion occurs, exacerbated by loss of the corneal reflex. This causes a decrease in tear volume, thinning of the aqueous tear film, and retarded spreading of the tear film lipid layer. Improper spreading of the lipid layer is hypothesised to cause an increase in evaporative water loss and an added evaporative component to the Aqueous deficient form of dry eye. Thus, in advanced disease, the hybrid state would be an organic ADDE, accompanied by a functional EDE in the absence of meibomian gland dysfunction.

This functional EDE would respond to agents that expand the tear volume, restore corneal sensitivity, or provide an artificial tear film lipid layer.

Conversely, in EDE, deficiency in quality and quantity of the lipid layer or inefficient spreading of the lipid layer leads to increased evaporation of tear fluid from the ocular surface. A compensatory lacrimal flow is reflectively maintained via the Lacrimal Functional Unit, by sensory drive from the ocular surface, so that EDE is initially a normal-tohigh volume hyperosmolar state. It is suggested that this compensation is lost in advanced disease, as hyperosmolar and inflammatory damage reduce sensory drive. Thus, when the primary phenotype is EDE, it is predicted that with disease progression, a hybrid form evolves in which an aqueous-deficient component is added to the dry eye.

The main risk factors associated with dry eye are older age, female sex, low dietary intake of omega-3 fatty acids, refractive surgery, radiotherapy, bone marrow transplantation, rheumatoid arthritis and Sjogren’s syndrome, hepatitis C and certain classes of systemic and ocular medications. Also environmental factors are involved, i.e. pollutants, air conditioning and computer work, which involves a reduction in the frequency of blink.

Courtesy Prof. M. Rolando

As mentioned above in the DEWS definition, dry eye is a multifactorial disease accompanied by increased osmolarity of the tear film, which plays a key role in its damage mechanism. This condition can result from two possible mechanisms constituting two forms of Dry Eye: aqueousdeficient dry eye (ADDE) and the evaporative dry eye (EDE).

Rose Bengal staining showing the damage in the nasal inferior region of ocular surface in patient with dry eye

Tear dysfunctions gives rise to the so called “dry eye”, a very widespread syndrome with a prevalence, in the general population, of 11–17% that increases with age.

Inflammation of the conjunctiva and accessory glands in 80% of patients may be the cause and the consequence of dry eye. Hyperosmolority and alterations of tear composition are also key mechanisms of disease and may be the major pathway for epithelial cell damage.

These mechanisms are closely related and they are able to produce a self-feeding “vicious cycle” in the phatogenesis of this disease.

It is evident that dysfunction of the tear film may occur in different ways depending on the nature of the cause and the stage of the disease. In particular, changes can be observed in the thickness and composition of each of the three film layers, so the first line treatment, artificial tears, should be individualised to address specific deficiencies in the

Sources for a deeper insight eport of the International Dry Eye WorkShop (DEWS) 2007; April 2007 Ocular Surface, Volume 5, Number 2.

R Behrens et al., Dysfunctional Tear Syndrome: a Delphi Approach to Treatment Recommendations. Cornea 25(8): 900-907, 2006.

Bron et al., Predicted Phenotypes of Dry Eye: Proposed Consequences of Its Natural History. The Ocular Surface 7(2): 78-92, 2009.

Stern et al., The role of the lacrimal functional unit in the pathophysiology of dry eye; Exp. Eye Res. 78: 409–416, 2004.

Lin et al., Prevalence of Dry Eye among an Elderly Chinese Population in Taiwan – The Shihpai Eye Study; Ophthalmology 10 (6): 1096-101, 2003.

Schaumberg et al., Prevalence of Dry Eye Disease among US Men: Estimates from the Physicians’ Health Studies; Arch. Ophthalmol. 127(6): 763–768, 2009.

tear film. Artificial tears are recommended for mild to moderate dry eye. When the disease is in an advanced stage and the damage has extended to the surface of the cornea with chronic inflammation the patients are often advised to add on an anti-inflammatory therapy, in order to restore the physiological conditions of the eye surface. Artificial tears are usually still used in combination with these anti-inflammatory agents.

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MAGAZINE

NEWS FROM THE ARTELAC® FAMILY

ALWAYS THE RIGHT SOLUTION FOR DRY EYES

With Artelac®, Bausch + Lomb’s product range for dry eyes, a lot has recently changed: the family got a new addition, existing family members received a new trendy look and new names. With the new product line every customer with dry eyes obtains an individual solution for her or his special needs. Let’s take a closer look.

Discomforts resulting from dry eyes can differ greatly – symptoms are more or less prominent, chronic or intermittent, with or without lacrimation. The customers and their needs are just as diverse: Professionals, elders, contact lens users or athletes have different demands on “their” product for dry eyes.

For Bausch + Lomb this was reason enough to thoroughly revise the product portfolio and adjust it further to the individual requirements. The result is a promising product line.

New Family Member: Artelac® Rebalance.

This innovative product was successfully introduced to the market in the fall of 2010 – a new solution specifically designed for customers with moderate to severe dry eye symptoms or a damaged corneal surface. Apart from the hydration with hyaluronic acid, Artelac® Rebalance consists of polyethylene glycol (PEG) 8000, which helps to prolong residence time on the corneal surface. The mineral nutrients potassium, calcium, and magnesium help reduce symptoms by matching electrolyte balance and supplementing the tear film.

low hormones

age medications certain medical conditions

cataract and refractive surgeries

menopause

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Factors that trigger and continue progression1,6 Tear film inbalance Triggers: • Age • Menopause • Low androgens • Cataract and refractive surgeries • Medical conditions • Medications • Gland dysfunction and inflammation

Unhealthy occular environment

*

While the cause of chronic tear film dysfunction is not curable, it is possible to break the cycle by providing hydration and balance to the tear film

These factors combine to exacerbate osmarlarity and tear instability problems in a continuous cycle of progression

Self-perpetuating process of epithelial damage

Local inflammatory response

Therefore, Artelac® Rebalance offers a particularly good hydration and additionally ensures relief and protection of the affected corneal surface.

Due to its practical dropper bottle, Artelac® Rebalance can easily be instilled and is therefore also suited for customers with reduced mobility.

Artelac Advanced became Artelac® Splash. ®

Introducing Artelac® Splash: The well-known advantages of Artelac® Advanced in combination with a new appealing package design and a memorable name!

The product is particularly suitable for active people, who have mild symptoms and look for a quick refreshment and hydration of their eyes.

Intensive work in front of screens and in airconditioned offices as well as wearing contact lenses lead to tired, stressed and irritated eyes.

With the help of the natural moisturiser, hyaluronic acid, Artelac® Splash provides relieving and refreshing hydration of the eye, which eases the symptoms and prevents recurrence. Artelac® Splash is preservative free, very well tolerated, and also suitable for users of both hard and soft contact lenses.

The dropper bottle is easy to use and its patented pump mechanism allows for precise instilling and a durability of 12 weeks after first usage. Moreover, the new product is also available in easy-to-carry single-dose units, providing active people with a drop of refreshment during sports, on the road or while travelling.

Now with a new Look: Artelac® Lipids.

Nocturnal: Artelac® Nighttime Gel

Apart from a new name Artelac® Lipids also received a design makeover and the product shows off in warm Artelac® colours. Like its predecessor Liposic Fluid, Artelac® Lipids is particularly suitable for very dry, irritated eyes as well as ocular surface inflammation and watery eyes.

Artelac® Nighttime Gel is a co-medication with depot-effect to be used at night. It complements the Artelac® Family. The product derived from the gel Liposic and is equally meant to be used by people with very dry, irritated, burning or watery eyes, who would like to give their eyes a care treatment during sleep. Applied at night, the depot-effect is fully exploited. It provides sustainable hydration and supplements all three layers of the tear film – the lipid layer, the aqueous layer and the mucin layer.

Watery eyes result from the irritation caused by tear film break-up. Therefore, in addition to Carbomer molecules for moisturisation, Artelac® Lipids also contains additional lipids, which improves the tear film stability and seals in the moisture. Hence, the eye is moistened particularly prolonged.

Artelac® Lipids is available in single-dose units, each containing a viscous gel droplet. They are very convenient on the road. Artelac® Lipids is also available in a dropper bottle.

Artelac® Nighttime Gel is a viscous gel, which remains on the ocular surface for a long time and has a cooling effect.

With all of these products the Artelac® Family is now complete and optimally positioned to meet individual customer needs. Due to its modern look and memorable names Artelac® is well prepared for the future market. In this way, we are able to optimally support our customers to always have a clear view.

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MAGAZINE

Distance To accommodate distance vision, the lens rests back in the eye.

Intermediate To accommodate intermediate vision, the lens gently flexes forward.

Near To accommodate near vision, the lens flexes even further forward.

CHANGING THE WAY YOU SEE THE WORLD A NEW PRODUCT FROM BAUSCH + LOMB IS GIVING PATIENTS CRISPER, BRIGHTER VISION, AT ALL DISTANCES What is Crystalens?

Crystalens is a remarkable breakthrough that works by mimicking the action of that ingenious invention: the human eye. It’s an ‘intraocular lens’ that uses the eye muscle to flex in order to focus on whatever you need to see. Crystalens is designed to allow the optic to move back and forth as patients constantly change focus on images around them.

Unlike standard intraocular (IOL) lenses, Crystalens not only treats cataract but also can treat ‘presbyopia’, the loss of near and intermediate vision that affects many people from middle age onwards. In fact, it can reduce or even eliminate their need for spectacles to help patients read, use a PC or drive a car.

Figure 1: Standard Spherical IOL

Positive spherical aberration

Crystalens works by accommodation, which in simple terms, is the contraction and expansion (relaxation) of the ciliary muscles pulling and pushing the crystalline lens. This also causes posterior vitreous pressure to translate into anterior pressure that moves the crystalline lens forward.

The Crystalens design team didn’t view the natural crystalline lens as an artificial model; instead, they used it as a literal road map. So the everyday function of the Crystalens – the way it actually moves in the eye – is as close as possible to the natural lens. The design of the Crystalens enables it to adapt to patients, rather than patients having to adapt to the lens.

Figure 2: Aberrated Aspheric IOL

There are two mechanisms of action of the Crystalens: The primary mechanism is the forward axial movement of the lens, called vaulting. Many surgeons will inquire – often with scepticism – about how much accommodation the Crystalens actually provides. Studies show that the Crystalens usually allows one dioptre or more of accommodation.

The secondary mechanism is the flexing or arching of the optic, called accommodative arching.

Capsular contraction slightly distorts the optic as it is forced anteriorly, changing the radius of curvature of the lens. This is also optic arching.

This causes the central power to increase in the accommodation process.

Figure 3: Aspheric Aberration-Free IOL

Negative spherical aberration

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The latest lens in the Crystalens range, Crystalens AO has the added advantage of the Bausch + Lomb Advanced Optics platform which means the lens is also aberration free.

Standard spherical lenses create positive spherical aberrations as the peripheral rays come to a shorter focus than the central rays. This results in degradation in retinal image quality, causing a loss in contrast sensitivity. (Figure 1) Aspheric lenses which try to make adjustments for the natural irregularities can cause problems as every patient has a unique optical system. Aspheric lenses using aberrated optics can potentially cause visual impairment if ocular misalignment occurs, leading to higher order aberrations such as coma.

(Figure 2) Aberration free lenses like the Crystalens AO, are neutral to the cornea, making them suitable for all patients regardless of corneal shape. This leaves the eye with its natural degree of corneal positive spherical aberration, with an improved contrast sensitivity, but provides patients with a good depth of field. (Figure 3)

What the consultants are saying...

Mr Som Prasad from the Murrayfield Hospital in the Wirral, Merseyside, UK “I saw a patient recently who was being admitted for his second eye procedure. He was very impressed with the results of his first operation a few weeks ago and can see perfectly, almost immediately. His only regret was that he had not had the operation sooner. Most of the cost for this was met by his insurer and he said it was the equivalent price of a pair of designer specs.”

Pavel Stodulka, Gemini Eye Clinics, Czech Republic “Crystalens AO is an excellent option and my first choice especially for night drivers with scotopic pupil size up to 5,5mm who want to see both distance and intermediate without compromise and without aberations associated with multifocal IOLs.” Dr Dominique Monnet, Hôpital Cochin, Paris, France When we asked him why he decided to implant Crystalens or why he prefers crystalens over MF he answered: “Accommodation is the future of cataract surgery.

I use Crystalens AO because of the excellent intermediate vision and because there is no decrease in vision quality, especially contrast sensitivity and side effects like halos. In addition, we don’t know the future of the condition of the retina as time progresses.”

Dr Hamdi (Head of Cornea and Refractive Surgery, Magrabi Centre – Jeddah Saudi Arabia / Assistant Professor Faculty of Medecin Ein Chams University – Cairo) “With Crystalens recent prototypes, the compromised quality of vision is something from the past. I can confidently advise my patients to get

“I saw a patient recently who was being admitted for his second eye procedure.

He was very impressed with the results… and can see perfectly, almost immediately.

His only regret was that he had not had the operation sooner…” benefit of it, without much worries. As a new user, I naturally had my internal debates. All these had gone after my first Crystalens patient, who was a 70 years old pilot, regained his 30 years old vision.”

Dr Elena Belikova, Gazprom Clinic Moscow “My experience of implantation Crystalens HD500 – more than 120 eyes. 95 % of our patients are happy with result. Monofocal optics of Crystalens HD give significant advantages of pseudophakic eye vision quality, that for many patients is the basic condition of successful postoperative result, especially with accompanying intraocular pathology. It’s important to understand and estimate desire of the patient and his readiness to go to the compromise between high near vision and excellent quality of optical perception. In my opinion, the successful result mortgage of the Crystalens HD implantation consists of three precise conditions: 1. Correct selection of patients 2. Proper calculation of target refraction with minimonovision 3. Correct performance of all stages of implantation (the main thing – uniform capsulorexis)”.

Mr Milind Pande from the Hull & East Riding Hospital in Anlaby, East Yorkshire, UK “The Crystalens provides an excellent focal range for all my patients. It is particularly good for people who work in a stressful environment and need to react to changing situations. Just one example is an anaesthetist colleague who developed a cataract in his only seeing eye. Crystalens provided the ideal solution in his case. After careful consideration and counselling, highlighting the pros and cons of the Crystalens, I operated on him with very good results. He now works without glasses and is extremely happy.”

Dr Druzhinin, MSTK Hospital in Novosibirsk, Moscow.

“Patients with cataract have a difficulty in choosing IOLs as there is a large selection of different models available. As a surgeon, it is not easy to decide either, particularly when you are asked to treat the father of an old friend. I decided to implant the Crystalens HD. Three months after the surgery I asked my friend how his father was and he told me that now his father is not afraid to travel by car at night and read newspaper to my friend who is 47, when he forgets his glasses.”

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MAGAZINE

BETTER VISUAL ACUITY WITH

ASPHERIC OPTICS GERRY CAIRNS

In being true to the aspiration of meeting the vision care demands of the population we serve, we must aspire to understand the needs of that population.

When providing advice on the various methods of vision correction, it is important that we listen and consider the needs of our patients.

assume that visual acuity is maximised with the use of spectacles versus soft contact lenses for most patients. This doctrine is supported by clinical studies showing that contact lens visual acuity and contrast sensitivity can be reduced by soft contact lenses;3, 4 however, this may be a false perception of modern, advanced designs of contact lenses.

To understand these needs, a recent global study of 3,800 vision-corrected patients was conducted to shed some light on how our patients think about their vision correction products. When asked to rank a list of 40 potential features of eye care products, covering a range of topics including vision, comfort and convenience, patients selected vision and vision-related features as 6 of the top 7 most important on the list.1 This was true regardless

In a study of myopic (–0.25D to –6.00D of myopia; Plano to –0.75D of astigmatism) patients with no contact lens wearing experience, visual acuity was compared between PureVision2® High Definition (PV2HD) contact lenses and the best sphero-cylidrical spectacle correction. Subjects were at least 12 years old, were required to have less than 1.00D of astigmatism, provided informed consent (or assent as appropriate) and the study

of the type of refractive error correction the respondent had (myopia, hyperopia, astigmatism, or presbyopia).

When patients present to their eye care professional for vision correction, the primary management of refractive error is spectacles.2 This is likely because it is considered the simplest and fastest option as no training is required to wear spectacles.2 Eye care professionals may also

Visual Acuity: Spectacles vs.

Soft Contact Lenses

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Overall, visual acuity measured for the 229 subjects that completed the study were excellent, with approximately 90% of subjects achieving 20/20 or better visual acuity with both the best spectacle correction and PV2HD lenses. When comparing all eyes from all patients in the study, there was no statistically significant difference in the proportion of eyes achieving better than 20/20 vision, between the PV2HD contact lenses and the best spectacle correction at all visits. (p>0.113 at each visit). However, when breaking out into groups of those without astigmatism (Plano to –0.25D; n = 312) and those with slight astigmatism (–0.50 to –0.75D; n = 146), an interesting pattern began to emerge. For the group with zero or –0.25D of cylinder correction, at the one week and the four weeks visits, there was a significantly greater proportion of eyes that had better than 20/20 visual acuity with the contact lenses (p<0.05 in both cases; Figure 1).

For eyes with more astigmatism (0.50D or 0.75D), the results were more in favor of the sphero-cylindrical spectacle correction, however, the difference was only significant at the 1 Week visit (p<0.05).

Aspheric Optics in Contact Lenses

When there is little or no astigmatism in the eye, the PV2 HD lenses can provide up to 10% more subjects with better than 20/20 visual acuity than the best spectacle correction Figure 1: Percentage of eyes with zero or 0.25D of astigmatism with visual acuity better than 20/20 with Best Spectacle Correction at baseline and PV2 HD lenses at dispensing, one week and 4 weeks.

100 90 80 Eyes Better Than 20/20 (%)

was approved by the Southwest Independent Institutional Review Board. For each subject entering the study, visual acuity was measured using a logMAR visual acuity chart with their best sphero-cylindrical spectacle correction. At each of the three visits: dispensing, one week and one month, visual acuity was also measured with the PV2HD contact lenses. The logMAR scores were converted into Snellen equivalent and analysis was performed to identify if there were differences in the proportion of eyes that achieved better than the 20/20 standard with either correction method.

70 60

46.2

51.5

52.2

Dispensing (n=312)

1 Week (n=297)

4 Weeks (n=289)

50 40 30 20 10 0 PV2 VA (Best spectacle correction at baseline provided 41.7% of eye with better than 20/20 logMAR VA).

optics). A single lens power was used in each study (+3.00D, –1.00D, –5.00D, and –9.00D). Baseline spherical aberration readings were recorded on pupils dilated to 6mm using a ZywaveTM aberrometer followed by a second reading through the contact lenses. High contrast logMAR visual acuities were recorded through the contact lenses using a 6mm artificial aperture.

lenses provided significantly better visual acuity (4.5 letters, 3.5 letters and 6.5 letters respectively; p<0.05 in each case).

Better Visual Acuity with Aspheric Optics Reduction of spherical aberration can improve an individual’s visual acuity.8 This series of studies has shown that incorporating aspheric optics into contact lens designs can significantly reduce the spherical aberration of the eyes’ optical system when compared to conventional spherical optics.

In addition, it has shown that the balafilcon A lenses with aspheric optics can provide better visual acuity over both spectacles and soft contact lenses with conventional spherical optics. When there is little or no astigmatism in the eye, the PV2 HD lenses can provide up to 10% more subjects with better than 20/20 visual acuity than the best spectacle correction. Given the high importance patients place on vision when selecting eye care products, contact lenses with aspheric optics should be considered when appropriate to meet patients’ needs.

The high level of visual acuity achieved with the PV2HD contact lenses in the above study may be attributable to the aspheric optics of the PureVision2® lens. Aspheric optics are routinely used to control spherical aberration in high resolution optical systems such as microscopes and telescopes. In contact lenses, aspheric optics are designed to reduce the inherent spherical aberration in the eye (+0.15 µm for the average population5, 6); however, it is important to realise that conventional spherical surface (non-aspheric) contact lenses actually induce spherical aberration. The amount of spherical aberration induced by standard spherical lenses varies with the power of the lens (Figure 2).7 An ideal contact lens with aspheric optics would correct both the spherical aberration of the eye and the spherical aberration induced by the contact lens, across all contact lens powers, even those including astigmatism correction.

Over all four studies, there was a statistically significant difference in spherical aberration reduction between the lenses. The balafilcon A lenses with aspheric optics reduced the mean spherical aberration by 0.136 µm whereas the senofilcon A lenses with conventional spherical optics reduced the spherical aberration by only 0.054 µm.

Aspheric Optics vs. Conventional Spherical Optics in Contact Lenses

1. Needs, Symptoms, Incidence, Global eye Health Trends (NSIGHT) Study. Market Probe Europe. December 2009.

2. Cochrane GM, du Toit R, Le Mesurier RT. Management of refractive errors. BMJ. 2010;340:c1711.

3. Cox I, Holden BA. Soft contact lens-induced longitudinal spherical aberration and its effect on contrast sensitivity. Optom Vis Sci. Sep 1990;67(9):679-683.

4. Wachler BS, Phillips CL, Schanzlin DJ, Krueger RR. Comparison of contrast sensitivity in different soft contact lenses and spectacles. CLAO J. Jan 1999;25(1):48-51.

5. Porter J, Guirao A, Cox IG, Williams DR. Monochromatic aberrations of the human eye in a large population.

J Opt Soc Am A Opt Image Sci Vis. Aug 2001;18(8):1793-1803.

6. Thibos LN, Hong X, Bradley A, Cheng X. Statistical variation of aberration structure and image quality in a normal population of healthy eyes. J Opt Soc Am A. Dec 2002;19(12):2329-2348.

7. Cairns G. Enhancing contact lens design for complete performance. Optician. 2007(February):14-16.

8. Piers PA, Manzanera S, Prieto PM, Gorceix N, Artal P. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. Oct 2007;33(10):1721-1726.

In order to compare high contrast visual acuity and spherical aberration measurements with spherical and aspheric soft contact lenses, a series of four studies was conducted using two marketed silicone hydrogel lenses (balafilcon A with aspheric optics and senofilcon A with conventional spherical

As a corollary, there was a statistically significant difference between the balafilcon A and senofilcon A lenses for high contrast, high illumination visual acuity (p<0.001). On average, the balafilcon A lenses with aspheric optics provided 3.5 letters better logMAR visual acuity than the senofilcon A lenses with conventional spherical optics. Similarly, for the –9.00D, –5.00D and +3.00D powers individually, the balafilcon A

References

∕ Denote trademarks of Bausch & Lomb Incorporated

® ™

12

MAGAZINE

CHARLES KELMAN INVENTOR OF PHACOEMULSIFICATION 1930–2004

BY RICHARD PACKARD

Beginnings

“…but first you’ll be a doctor” with these words to the teenaged Charles Kelman his father ensured that the world would have phacoemulsification. However, the story of how it became the accepted technique in the developed world and aspired to elsewhere, is hardly straightforward.

Charles Kelman, or to those of us who knew him “Charlie”, was born in 1930. His father was a Jewish immigrant from Greece (see Fig. 1).

and he thought his career was made.

However a dance craze called “The Twist “ came along and changed the pop music scene. Charlie’s career as singer ended so he felt he should make his mark as an ophthalmologist.

However he had developed a taste for entertaining and enjoyed recognition as a “somebody”. He wanted recognition to apply to him as an ophthalmologist also. He needed to find ideas that would bring this to fruition.

Charlie grew up in a middle class neighbourhood in Queens one of the 5 boroughs of New York.

His father had been something of an inventor but never received adequate reimbursement & recognition for his efforts and Fig. 1 Charlie Kelman’s father this certainly affected Charlie His first efforts in this regard centred on the use (for Charlie it was about recognition; the money of extreme cold in surgery. He had seen the was a bonus). publicity surrounding a neurosurgeon who used Medicine was certainly not Charlie’s first love, it a cryoprobe for treating Parkinson’s disease and was music. He grew up in the era of the great swing wondered if this might have uses in ophthalmology. dance bands and as a teenager wanted to be a Charlie managed to inveigle his way into the musician and play with them. Although his grades at laboratory of this neurosurgeon and started to school were not outstanding he managed to secure experiment. He found that a cataract could be a place at Tufts University from where he graduated extracted in its entirety with a cryo device. However, in 1950. He then went to study medicine at the his mentor having realised that he might be on to University of Geneva. Charlie had been a talented something took over his work and he was cut out of musician in High School and started composing at any credit there might have been for his invention. the time. He continued playing and composing in This rankled extremely and would colour Charlie’s Geneva as well. He worked at a radio station and attitude to sharing information about his subsequent performed at clubs. He published a song which work, certainly in the initial phases. was recorded by Jean Sablon, Le Petit Dejuner, Having observed the effects large incisions needed Paroles et Musique de Francois Charpin et Charles for cataract surgery at that time had on patients and Kelman. In 1953 whilst away in Geneva he heard their recovery from surgery, ten days immobilised the bad news that his father had been diagnosed in hospital and slow recovery after that. Charlie with cancer. He subsequently died in 1955. This wondered if it might be possible to devise a means was a major blow for him and spurred him on to graduate as a doctor in 1956.

of removing a cataract through a small incision and thus avoid any hospitalisation. With this in mind he approached the Hartford Foundation, a charity, and was given funds for a three year study. He did not have a clue as to how he would achieve this aim.

After almost three years of wasted ingenuity and extensive animal study he had spent all the funds.

He had tried all manner of devices to extract a cataract through a reduced incision without success (see Fig. 2).

Although the devices he tried could engage a cataract, either it would spin in the eye or simply not come out as planned. The damage to delicate ocular tissues was extensive. Thus the time had come to report on his research and try to apply for more funds from the Hartford Foundation.

As a result of his obsessive approach to his work, Charlie Kelman had neglected himself – long hair and teeth in need of a dentist. The dentist that he went to see was using a new device to clean teeth.

It vibrated at ultrasonic frequencies and removed plaque from teeth. Charlie was very excited by this (see Fig. 3).

He rushed from the dentists office shouting “I’ve got, I’ve got it…” When he came back a short while later, having obtained a newly extracted cataract he made a remarkable observation. For the first time he was able to engrave lines on the cataract without it jumping from his hand. The sole reason for this was due to this device’s ability to accelerate into the lens tissue. This was a function of its very rapid rate of vibration.

Having graduated Charlie decided that ophthalmology looked like a good career as he would have plenty of time for his music. He managed to persuade the powers that be at the Wills Eye Hospital to allow him to join their residency programme. Charlie continued to submit songs he had written to record companies and one in particular called “Telephone numbers” excited interest. He was asked to make the record himself based on his demo tape and did so as “Kerry Adams” as he did not want his medical colleagues to know what he was doing. It was a hit Fig. 2 Some early failed instruments for small incision cataract surgery

Fig. 3 Cavitron dental cleaner

13

Fig. 5 Photo from original phaco procedure

Fig. 4 Advertisement for first Cavitron phaco machine

Having made this observation it was necessary to build a machine that could be used for eye surgery. Charles Kelman worked with the Cavitron company, the makers of the dental device, to create the first phaco machine (see Fig. 4).

Many of the things we take for granted about our phaco machines today were simply not known. Despite this, in 1967 whilst working at the Manhattan Eye, Ear and Throat Hospital, he felt ready to try out his new machine on a blind eye.

The patient in question submitted to the surgery knowing full well that what he was doing was purely for the benefit of medical research. The operation was carried out in great secrecy and the operating room door was locked. As a surgical procedure it took over 4 hours. The actual phaco part of the operation took 70 minutes. The phaco handpiece was extremely heavy by comparison with those in use today and the surgeons hand became fatigued frequently during the operation. The original video of the operation demonstrates how often the cornea collapsed onto the phaco tip due to inadequate understanding of the fluidics balance required (see Fig. 5).

Over the next two years extensive changes were made to the phaco machine. Charlie felt it was time to try again. After three more eyes and a rapid learning curve with improvements to technique and outcome at each subsequent procedure, he began to think his idea would work. Unusually for the time, he decided that his invention would be his alone especially after his experience with cryo extraction.

He made sure no one would steal it from him by patenting his ideas and entering into a contractual arrangement with Cavitron.

Fig. 6 Early teaching video from 1970

Controversy By 1970 Charles Kelman felt he had done enough development to start to train other surgeons in his new operation. He began to hold courses in New York which he ran himself (see Fig. 6). As most surgeons at that time did not use the operating microscope for their cataract surgery, this early group needed to demonstrate the necessary manual skills. Charlie was meticulous about this, using a variety of devices to achieve this, again something never before done in cataract surgery.

Although the normal method of letting the ophthalmological community know about his work would have been to publish papers in peer reviewed journals, this was ignored. Those who attended the early courses largely did so because of word of mouth. These early acolytes were almost exclusively in active private practice and not at the great academic ophthalmic institutions. When the denizens of these august institutions became aware of what Charlie was up to there was a negative reaction. The comments varied from describing phaco as “malpractice” to “ridiculous” and anyway who knew what were the long term effects on the cornea. This resulted in the National Eye Institute declaring that phaco was experimental. The effect of this was for medical insurance companies to withdraw reimbursement for the procedure.

some at his own university tried to persuade the FDA to allow them to be a National Center for collecting adverse data about this new operation.

It turned out there was so little that the enterprise died on the vine. By 1974 the American Academy of Ophthalmology felt it should set up a committee to compare phaco with conventional intracapsular cataract surgery, then considered the state of the art. The committee reported its findings at the AAO meeting in Dallas. In order to try to make sure there was fairness Charlie had organised his own statistical review of results over and above that done by the Academy. The outcome was that at least phaco was said to be as good as conventional surgery but no better. Thus phaco was not endorsed. By this stage Charles Kelman was convinced of the rightness of what he was doing as were a coterie of those he had taught. He decided to do something never done before by going public on his invention. He also wanted to flaunt his achievement in front of his doubting colleagues some times by shock tactics (see Fig. 7).

In 1973 at an annual cataract conference the Welsh Cataract Symposium surgeons lined up to tell of their bad experiences with phaco. However, it seemed these people were generally not phaco surgeons themselves. Patients with bad results were paraded at the event. One of the early adopters of phaco Spencer Thornton remembers well how Fig. 7 Charlie and assistants

14

Fig. 8 Charles Kelman on the Tonight Show

On February 21st 1975 he appeared on the most prestigious chat show at that time on US television, the Tonight Show, hosted by Johnnie Carson (see Fig. 8).

Not only did he joke with Carson on air dressed like a media personality but he played his saxophone. His practice ballooned overnight and at the same time he thumbed his nose at the ophthalmic establishment.

Recognition Despite this success it was not until a foldable intraocular lens became available in the mid 1980s, designed by Thomas Mazzocco, that large numbers of surgeons started to look seriously at changing to phaco. In 1985 Charles Kelman published his account of the battle to develop phacoemulsification and then get it accepted. The book “Through my eyes” had the sub-title “the story of a surgeon dared to take on the medical world” (see Fig. 9).

The implication is that Kelman won although he felt some might doubt this.

I first met Charlie in 1979 when he came to Charing Cross Fig. 9 Cover of Hospital in London to teach a “Through my Eyes” phaco course. I was asked by my mentor Eric Arnott, the first surgeon in Europe to perform phacoemulsification, to give a talk on learning to do phaco. We became friends and over the years did many meetings together. In 1986 we taught a European phaco tour in London, Antwerp, Munich, Bologna and Athens over a 10-day period. We did live surgery in all the venues except Antwerp. Charlie treated me, a relative unknown, with extraordinary intellectual generosity as we made our way across the Continent. I felt as though we both mattered equally even if it was he that actually made the difference. Almost everyone who encountered Charles Kelman would agree that, even if he was the centre of attention, he made others feel important than him.

As the 1980s progressed, techniques and technologies in phaco advanced too. By the end of the decade foldable IOLs were well established and improvements in machine technology meant that many more surgeons felt they should convert to small incision surgery. During the 1990s Charles

MAGAZINE

Fig. 10 Charles Kelman receiving presidential award from George Bush Snr

By the end of the decade foldable IOLs were well established and improvements in machine technology meant that many more surgeons felt they should convert to small incision surgery Kelman was finally recognised by all for the way his invention of phacoemulsification was changing cataract surgery forever. In 1992 Charlie was awarded The National Medal of Technology by President George H. W. Bush, (see Fig. 10) but despite these honours he did not feel truly fulfilled.

His love of performing music had to some extent been met by the entertainments he

Fig. 11 Playing at Atlantic City

used to run at the end of his teaching courses in New York. He still sought other challenges outside ophthalmology. He learnt to fly helicopters and acquired his own to get from his office in Manhattan to his house on Long Island. He performed his own show at a casino in Atlantic City and also at Carnegie Hall in New York City (see Fig. 11).

He learnt to play golf and in order to assist in this employed a golf professional to be with him over several months to improve his technique as rapidly as possible. He also remarried and started a new family. While all this was going Charlie was constantly trying to think of new ways to remove the cataract and replace it with a lens. His Binkhorst lecture of 1989 delighted all who heard it with his innovative use of electromagnets to break up the cataract in the eye, “the magnetic fly”. He also proposed the use of the patient’s own collagen to create a clear gel that would fill the empty capsular bag after the contents had been removed. This would then accommodate. These ideas never came to fruition.

Although the senior members of the American Academy of Ophthalmology had been some of the most outspoken critics of phaco in the 1970s. It was not until 2003 that Charles Kelman was awarded the Academy’s highest honour by being elected a Laureate. In his lecture he retold the early history of phaco whilst thanking the Academy for the honour they had bestowed upon him.

Last words In 2004 Charlie’s 6 year tussle with his metastatic lung cancer finally ended when he died in June of that year. A glittering array of friends from the worlds of ophthalmology and entertainment attended the wonderful memorial event which, typically for Charlie, took place in a Broadway theatre. Tributes were paid by many who had known him from all spheres of his life. I was very glad I had made the journey from the UK to wish him a last farewell.

Sadly Charlie’s ultimate accolade was awarded not long after he died. Later in that year his sister received the Albert Lasker Basic Medical Research Award on his behalf. This is the U.S. highest award for medical science. It was the first time it had been given posthumously.

What was Charlie’s contribution to our specialty of ophthalmology? He demonstrated that when you have an idea, in which you truly believe, take it forward regardless of the opposition. In the end that opposition will come to understand how they were wrong. Without the revolution that Charles Kelman started we would still be languishing in an era with 12mm cataract incisions, held together with multiple stitches, and everything that implied for our patients.

I would like to acknowledge the assistance I have received from Mrs Ann Kelman and the Dr Charles and Ann Kelman Family Foundation in the preparation of this chapter.

15

PHACOEMULSIFICATION IN THE 21ST CENTURY Developments in small incision surgery have continued and a big step forward came in 2007 when Bausch + Lomb launched the Stellaris Vision enhancement system.

The Stellaris could finally deliver 1.8mm BMICS or CMICS for both vacuum and flow surgeons and really set the benchmark for all future developments.

Just as in the mid 1980’s the introduction of foldable lenses made phaco popular it was the availability of MICS lenses that have paved the way for 1.8mm MICS. The Akreos MICS lens is composed of biocompatible, hydrophilic, acrylic material, which makes it incredibly strong jet flexible enough to be

inserted through a 1.8mm incision. This awardwinning lens was recognised for its innovative design; the Akreos MICS lens received the prestigious Gold award in 2008 at the Medical Design Excellence Awards (MDEA).

Today MICS has become a key focus for ophthalmic surgeons worldwide; there are now

numerous MICS lenses on offer, BMICS has been used with incisions of 1mm, and more surgeons are making the simple switch to CMICS. But there is so much more to the Stellaris system than just the ability to perform 1.8mm MICS. Fluidics: Balanced fluidics is vital for MICS procedures. The Stellaris system’s EQ Fluidics Management Technology has been specifically designed to equalise aspiration and irrigation to optimise chamber stability during MICS cases.

Hand piece: The Stellaris uses a new 6 crystal configuration hand piece which provides efficient cutting of nucleus. The 28.5kHz hand piece optimises cavitation and rapid emulsification with minimal thermal loading. An increase in stroke length provides more efficient cutting of the nucleus, with a tighter, more focused consistent stroke.

Modularity: The Stellaris has been designed to be infinitely adaptable to each surgeon’s individual needs. Furthermore, its unique modular design allows future innovations to be incorporated, therefore avoiding obsolescence that hampers other systems.

Dual Linear: It provides surgeons with a rapid response owing to the simultaneous independent linear control of fluidics and phaco power in two planes of pedal movement. The Bluetooth wireless foot pedal has per-programmable settings that can be customised to the surgeon’s technique allowing phaco power to be adjusted via and up-and-down movement of the pedal (Pitch) and fluidics via a side-to-side movement (Yaw). However, if the surgeon prefers the pedal can be programmed with the fluidics on the Pitch and the phaco power on the Yaw.

The Wide Angle Light Pipe provides a 115° field of illumination.

Stellaris ® PC Wide Angle Light Pipe

For bright, clear, panoramic visualisation Technical Information

115° field of illumination Designed to prevent shadows, rings, and hot spots

Connects to Stellaris PC Illumination Module, which offers 2 lamp types and 3 tissue-differentiating filters

Reduces need to move probe during surgery

Tapered tip is designed to reduce thermal output

Helps minimise glare

Optimised fibre-tip angle distributes light uniformly without glare

Designed to reduce thermal output

Available in 3 gauges

BL5825

BL5823

BL5820

Stellaris PC, 25 GA Wide Angle Light Pipe

Stellaris PC, 23 GA Wide Angle Light Pipe

Stellaris PC, 20 GA Wide Angle Light Pipe

Each box contains 6 individual sterile pouches.

Contact your local B+L representative to arrange a demonstration. www.stellarispc.com

© 2011 Bausch & Lomb Incorporated. Stellaris is a registered trademark of Bausch & Lomb Incorporated.

In 2010 Bausch + Lomb launched Stellaris PC. This machine still has the sleek design, small footprint, and a wireless foot pedal with dual linear control but is also a new platform for combined anterior and posterior segment surgery combining world-class vitrectomy and phaco capabilities in one state-of-the-art system offering procedural choice with TSV and 1.8 MICS. ‘In my opinion, the Stellaris PC is the first truly complete combined surgical platform and has become my most effective partner in surgery.

The machine has features that make the transition from anterior segment to the posterior segment extraordinarily smooth in terms of safety and efficacy, so surgeons no longer need two systems to perform both surgeries at the highest level.

The posterior segment surgeon will find Stellaris PC the best partner for advanced vitreoretinal surgery, without the need for a second machine for advanced cataract surgery.’ Roberto Bellucci, MD, Head of the Ophthalmic Unit, University Hospital, Verona, Italy.

For more information on the Stellaris MICS, Stellaris PC & Akreos MICS lens please visit www.bauschsurgical.com

16

MAGAZINE

VISION NEEDS SHOWN TO BE OF HIGHEST IMPORTANCE AMONGST A VISION-CORRECTED POPULATION AUTHORS: MARJORIE J. RAH, CARLA J. MACK, MOHINDER MERCHEA

17

Selecting eyecare products can be a daunting task for some patients. Recommendations from their eye care professionals (ECPs) simplify the process; however, patients have notions of what is important or compelling to them when purchasing products for their eyes. It is essential for ECPs to communicate effectively to determine what is important to patients when making their recommendations.

An online survey of 395 adult contact lens wearers, showed that patients who are most satisfied with the level of communication they get from their ECP are much more satisfied with their visit overall (81% vs. 13%) and much more satisfied with the level of vision care they receive (95% vs. 8%). As a result, they are almost 3 times more likely to return to their ECP in the future, more than 4 times more likely to recommend their ECP to friends and family, and 10 times more likely to follow their ECP to a new location.1

Personal Performance

Compelling Features of Eye care products

Personal Appearance

Another study was conducted consisting of 3800 vision-corrected subjects across seven countries, between 15 and 65 years old. Subjects completed a global online survey in which they ranked 40 individual features, in order of most and least compelling, when choosing products for their eyes. Of the 40 features, the most compelling top three individual features were: provides the best possible all around vision; renews lost vision; and provides vision that is as natural as possible, with utility indices of 192, 188, and 182 respectively.

The 40 individual features were categorised into the following eight areas: eye condition, health, vision, comfort, personal performance, personal appearance, environment, and convenience. Of the eight categories, only vision produced a utility index indicating the feature or category of features was highly important (utility index = 161). Vision was followed by health with a utility index indicating medium importance (utility index = 136). The personal performance and personal appearance categories ranked as least important of the eight categories with utility index scores of 33, and 25 respectively (Figure 1).2

Vision

161

Health

136

Environment

114

Eye Condition

108

Convenience

87

Comfort

81 33 25 0

50

100

150

200

Figure 1: Hierarchy of categories when choosing eyerelated products. Utility index scores between 150 and 200 represent categories of high importance; scores between 100 and 150 are of medium importance; and scores less than 100 are of minimal importance.

100

80

60

58 52

%

49

40

20

0 Halo

Glare

Blur/Hazy Vision

Figure 2: Percentage of patients suffering from symptoms who report experiencing the symptoms at least 3–4 times per week or more.

References 1. ECP and Patient Communications Study. Directions Research Inc., August 2010.

2. Needs, Symptoms, Incidence, Global eye Health Trends (NSIGHT) Study. Market Probe Europe. December 2009.

3. Journey to Work: 20000, Census 2000 Brief. Published March 2004.

US Census Bureau http://www.census.gov/prod/2004pubs/c2kbr-33.pdf.

4. Porter J, Guirao A, Cox IG, Williams DR. Monochromatic aberrations of the human eye in a large population.

J Opt Soc Am A Opt Image Sci Vis. Aug 2001;18(8):1793-1803.

5. Thibos LN, Hong X, Bradley A, Cheng X. Statistical variation of aberration structure and image quality in a normal population of healthy eyes. J Opt Soc Am A. Dec 2002;19(12):2329-2348.

Halo, Glare, Blurry Vision The same subjects were also asked which of 14 individual symptoms they suffered. Of the 2,124 contact lens wearers who completed the survey, 39% reported experiencing halo, 41% reported experiencing blurred or hazy vision, and 46% reported experiencing glare; approximately half of whom reported experiencing the symptoms at least 3–4 times per week (Figure 2). At least 84% of those suffering from these vision-related symptoms are somewhat or very bothered. Less than 10% have a complete solution for these symptoms; however, at least 87% of lens wearers that experience the symptom would be interested in a solution. Those who reported symptoms of halo, glare and blurred or hazy vision reported driving as one of the top three instances when confronted with the symptoms.2 Additionally, symptoms of halo and glare are experienced when confronted with bright lights (such as sunlight or headlights), and in dark environments or with nighttime viewing. When you combine this with the report that 24.5 million people leave their homes for work between midnight and 6:29 a.m.3, this represents an important area of concern to address with patients.

When seeking a solution for these patients, looking for the source of the symptom can be helpful. Common refractive errors such as myopia, hyperopia, and astigmatism are easy to identify and correct. However, higher order aberrations are subtle optical defects that can cause blur, halos, and glare. Spherical aberration is one type of higher order aberration that has been frequently linked to halos and glare when uncorrected. The average spherical aberration of the eye in the general population is approximately +0.15µm for a 6mm pupil size,4, 5 which may result in a degraded image quality, glare and halos. This is especially true in low light situations and for patients with a large pupil size. In addition, low contrast visual acuity may be significantly reduced by spherical aberration.

Importance of Visual Quality When patients trade off various functional solutions, it becomes clear that vision, health and environment are the top three priorities or needs when choosing products for their eyes.2 Vision-related symptoms of glare, halo and blurred vision in contact lens wearers are very common and bothersome.

There is both an unmet need for better vision and a perceived lack of an acceptable solution in the vision-corrected population. Yet, ECPs have options to reduce spherical aberration available in both spectacles and contact lenses that can help address these needs.

Vision is highly important to patients all around the world.2 As eye care professionals and vision experts, we have the opportunity to provide our patients with the best vision treatment options.

When providing treatment options for patients, it is essential to understand that the most compelling feature for patients choosing eye-related products is their vision.

18

MAGAZINE

SILICONE HYDROGEL LENS WETTABILITY WITH SELECT CONTACT LENS SOLUTIONS; HELPING KEEP LENSES MOIST BUT FOR DIFFERENT LENGTHS OF TIME CHRIS SNYDER, OD, MS, FAAO, DIRECTOR, PROFESSIONAL RELATIONS, BAUSCH & LOMB INCORPORATED, CATHERINE SCHEUER, MS, SENIOR RESEARCH SCIENTIST, BAUSCH & LOMB INCORPORATED

Wetting Agent Release from Silicone Hydrogel Lenses (Agerage of balafilcon A, senofilcon A and lotrafilcon B)

Biotrue Replenish Clearcare HBSS buffer control

differences in the length of time wetting agents are released among the lens/CLDS combinations tested. A greater difference measured between test solution and HBSS control (which has no surfactants present) indicates a lower surface tension and a greater ability of the solution to provide wetting.

20.0 -

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Surface Tension (mN/m) Difference from HBSS

It is well known that a good tear film on the surface of a contact lens is critical to quality of vision and lens wearing-comfort.

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Contact lens disinfecting solutions (CLDS) typically include wetting agents to support and enhance the wetting ability (“wettability”) of the contact lens surface in its interactions with the tear film and ocular surfaces. Wetting agents are also referred to as surfactants (“surface active agents”) because of their key action of reducing surface tension. As the surface tension of a solution decreases with the addition of a wetting agent/surfactant, the energy required for the liquid to spread across a surface may be reduced. Reduced surface tension may be measured indirectly by assessing the contact angle (the angle at which a liquid meets a solid surface).1,2 The increased tendency for a liquid to spread over a surface as the contact angle decreases suggests that lower contact angles can be an indication of a more wettable surface.2 Contact angle has been used to indirectly characterize the wettability of a surface by measuring the surface tension of a solvent droplet at its interface with a surface.1 Sessile drop is one of the most commonly used techniques for measuring contact angle. It is a static method in which fluid droplets are placed on a surface until a plateau is reached (advancing contact angle).2 Receding contact angle is measured as the droplet is retracted from the surface. There is normally a high level of experimental variability resulting from sample pre-hydration, surface roughness, chemical heterogeneity, evaporation and/or molecular movement.2 Another method of measuring contact angle is the captive bubble method. In this method, the contact angle is measured between an air bubble of defined volume and the solid surface immersed in the temperature controlled bath.3,4 This method is usually quite difficult in that the substrate must be consistent and the method of placing the vapour under the fluid and the substrate is quite difficult.5 Both sessile drop and captive bubble measures may be altered greatly by minor changes in methodology, hence the significant variability in such reported measures.

An alternative method to characterise the wettability of CLDS-soaked contact lenses over the course of time representing a full day of wear is to evaluate

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Statistical differences in the surface tensions between rinse solutions from the various lens/CLDS combinations indicated

the rate of release of wetting agents. This analysis represents a more real world overnight treatment of contact lenses and is accomplished by soaking the lenses for 8 hours in CLDS or in a buffer solution (Hanks balanced salt solution, HBSS) as a control, and then rinsing them with HBSS over time at a rate that approximates tear flow. The rinse solutions are collected every two hours and the surface tensions of diluted samples are measured with the Du Noüy ring method and tensiometer for direct measures of wettability.6,7 Statistical tests (t-Test on paired data) are performed to evaluate for differences in surface tensions among CLDSsoaked and HBSS-soaked lenses (p<0.05).

Bausch + Lomb performed tests using this method over a 20 hour period. The results from such testing of silicone hydrogel lenses shows how long wetting agents are released from the lens over the course of 20 hours (Figure).

The extended presence of wetting agents in the CLDS-soaked lens rinse solutions, as indicated by a reduction of surface tension relative to HBSSsoaked lens rinse solution, demonstrates that

Comparatively, the test results show that Clear Care® was not significantly different from the HBSS control after 4 hours, OPTIFREE® RepleniSH® was not significantly different from the HBSS control after 4 hours, but Biotrue™ multi-purpose solution was significantly different from the HBSS control up to 20 hours on average across all lens materials tested (p<0.05).

surfactants are retained and released by contact lenses. This objective methodology allows for a direct measure of the presence of surface wettability impact from a lens care solution and is not prone to the limitations of techniques such as captive bubble or sessile drop measures.

This surface tension methodology allows us to start seeing some differences between the various CLDS products, some of which claim to have wetting properties tied to estimates of length of contact lens wear (i.e. 14 hours). Comparison of this in-vitro study data to clinical studies may help to explain performance differences between CLDS for silicone hydrogel or hydrogel contact lenses particularly on comfort and dryness symptomatology. A recent clinical trial with Biotrue™ multi-purpose solution showed that 8 in 10 patients using Biotrue™ with hydrogel and silicone hydrogel lenses agreed that Biotrue™ delivered a clean, comfortable feeling throughout the day, suggesting that direct measures of surface wettability may help describe CLDS performance differences.8

References 1. Rosen, MJ. 1978. Surfactants and interfacial phenomena, Chapter 5. Reduction of surface and interfacial tension by surfactants. John Wiley & Sons, Inc. 2. Rosen, MJ. 1978. Surfactants and interfacial phenomena, Chapter 6. Wetting and its modification by surfactants. John Wiley & Sons, Inc. 3. Birdi, K.S. Handbook of Surface and Colloid Chemistry, CRC Press, Boca Raton, FL, 2009 4. Encyclopedia of Surface and Colloid Science vol. 1, A.T. Hubbard, ed., Marcel Dekker, New York, NY, 2002.

5. Neumann AW, Godd RJ. Techniques of measuring contact angles. In: Good RJ, Stromberg RR, editors. Surface and colloid science—Experimental methods, vol. 11.

New York: Plenum Publishing; 1979.

6. Morrison, I.D. and Ross, S.; Colloidal Dispersions: Suspensions, Emulsions, and Foams; John Wiley & Sons Inc., New York, NY, 2002, p.202.

7. Thiessen, D.B. and Man K.F.; “Surface Tension Measurements” in The Measurement, Instrumentation, and Sensors Handbook; Webster, J.G., ed.; CRC Press, Boca Raton, FL, 1999, p. 31.5-9 8. Results from a clinical trial in which a total of 291 subjects were enrolled across 15 investigative sites. Patients’ subjective assessments were measured using a six-point Likert Scale in which 1 = strongly disagree and 6 = strongly agree. Results represent reported percentage agreement ratings. (data source: Bausch + Lomb).

20 hours of moisture in every drop.*

Biotrue® multi-purpose solution helps keep lenses moist for up to 20 hours.* Inspired by the biology of your eyes,™ Biotrue helps make lens wear easier on the eyes.** Maybe that’s why: 1 Patients prefer Biotrue 3:1 over OPTI-FREE RepleniSH 97% of patients who tried Biotrue are satisfied with it 8 out of 10 patients are more willing to recommend their Eye Care Professional to their family and friends after having Biotrue recommended to them

Recommend the solution that keeps lenses moist — longer.

Learn more at www.biotrue.co.uk Contact your Bausch + Lomb sales representative or call customer services on:

0845 602 2350

1800 409 077

Email: orderline@bausch.co.uk | Order online: www.bauschonline.co.uk

*Results of a U.S. in vitro study performed to evaluate the release of wetting agents from various silicone hydrogel lens materials over a period of 20 hours. **Based on a U.S. patient satisfaction study.

1. Consumer Preference Study (Dec 2010) conducted by Bruno and Ridgeway among 201 consumers who have tried Biotrue, of which 130 tried Biotrue and OPTI-FREE RepleniSH. © 2011 Bausch & Lomb Incorporated. ®/™ denote trademarks of Bausch & Lomb Incorporated. All other product/brand names are trademarks of their respective owners. PNG04120

Glistenings do exist.

Actual slit-lamp photograph of glistenings in a competitive acrylic IOL.

But not for enVista.

™

Introducing the new standard in acrylic IOL performance.

No glistenings detected at any time in a 2-year prospective study1,2 Bausch + Lomb aspheric Advanced Optics Insertion through a 2.2-mm incision Designed to minimise PCO Contact your B+L representative to learn more about enVista, a revolutionary new IOL. 1. enVista™ Directions for Use. 2. Tetz MR, Werner L, Schwahn-Bendig S, Batlle JF. A prospective clinical study to quantify glistenings in a new hydrophobic acrylic IOL. Presented at: American Society of Cataract and Refractive Surgery (ASCRS) Symposium & Congress; April 3-8, 2009; San Francisco, CA.

©2011 Bausch & Lomb Incorporated. ™ denotes trademark of Bausch & Lomb Incorporated. SU6635 09/11

Glistening-free hydrophobic acrylic IOL

Just say ‘no’ to glistenings.