Autumn 2010 / Issue 10 Innovative Lens Care Inspired by the Biology of the EyeEducation Practice Development Science + Technology4 40 years of Minims 16 The Ten Commandments of patient education 18 Gas Permeable lens manufacture8 Dual Linear gives you more versatile control
2 MagazineEditorialDear ColleaguesT he nights are beginning to draw in as Autumn begins but it continues to be a busy time for Bausch + Lomb. We are proud to announce that Biotrue™, a remarkable new contact lens solution inspired by the biology of your eyes, is now available. Read all about the product inour lead article on page 10. Your local Territory Manager can also tell you about our rangeof unique Biotrue™ point-of-sale materials that create eye-catching theatre in store andencourage lens wearers to try the latest in lens care technology.We continue to invest in research to understand consumer needs and in our feature onpage 19. we learn that recent results have shown driving at night is a problem for 1-in-4young daily disposable wearers. We explore how this can be turned around to provide anopportunity for your practice by fitting SofLens daily disposable contact lenses.The demand for Gas Permeable (GP) lenses is still very evident and Bausch + Lomb providesa comprehensive service to support our GP customers. Read more about GP customersupport and training, and our new lens packaging innovation on page 18.Following on from last issue, we feature the second instalment in John Hovenesian and PaulKarpecki’s series of articles on developing your premium intraocular lens practice. Onpage 16 they identify the ‘Ten Commandments’ of dealing with presbyopic patients. You canalso take a look at some of the clinical results that have been achieved with our AkreosMICS intraocular lens on page 7. Two surgeons from Lincoln County Hospital share theresults of a study that demonstrates the benefits of the revolutionary design of this lens.We also take an in-depth look at one of the unique features of Bausch + Lombphacoemulsification machines; the dual linear footpedal. Many of you may use aMillennium® or Stellaris® every day without having discovered the versatility thatthis system affords the cataract or vitreoretinal surgeon. To find out how it couldassist you during surgery, turn to page 8.This year we’re celebrating four decades of Minims®! On page 4, in adedicated article, we review the single-dose range that remains centralto ophthalmic and optometric practice. We look at the history of theproduct line, review the benefits it provides, and conclude with adebate on the role of single-dose products in today’s highly regulatedand risk-aware health system.Finally, looking forward to our educational programme in thecoming months, Bausch + Lomb is proud to continue its successfulseries of ophthalmic meetings, the next being chaired by John Salmonin Oxford on 15th November. See page 6 for a full list of future datesand details of how you can reserve your place.Kind regardsJill CollishawEditor, Visions MagazineBausch + Lomb Contact DetailsBausch & Lomb UK Limited Customer Services Customer Services Customer ServicesBausch & Lomb House Pharmaceuticals Surgical Vision Care106 London Road Tel: 020 8781 2991 Tel: 020 8781 0000 Tel: 0845 602 2350Kingston-upon-Thames Fax: 020 8781 0001 Fax: 020 8781 0001 Fax: 0845 602 2351Surrey KT2 6TN Email: firstname.lastname@example.org Email: email@example.com Email: firstname.lastname@example.orgMain Switchboard Tel:020 8781 2900Main Fax: 020 8781 2901
3 Product NewsStellaris PCThe Stellaris PC is a high-performance, feature richcombined platform that leverages Bausch + Lomb’s historyin retinal innovation to change the surgical landscapeby delivering the ultimate in procedural choice.Advanced – Technology Versatile – Proceduralthat makes a difference. choice with TSV and MICS.Efficient vitrectomy Procedure Choice+ 5000cpm designed to reduce traction + Select vitrectomy, phaco or combined procedures and turbulence + Full flexibility with 20, 23 and 25 gauge packs+ Port located close to cutter tip for controlled tissue removal Phaco that is safe and efficient + Easy transition to MICS 1.8mm technologyStable Fluidics + Attune Energy Management System self-adjusts+ Optimised duty cycle for built-in flow efficiency to maintain smooth performance+ Auto infusion allows surgeon to toggle on/off + Exceptional safety with StableChamber fluidics the BSSOptimised visualisation Different – Simplicity+ Dual independent lamps (Xenon and Xenon and surgeon control. Mercury) Simple, logical human factors+ 3 surgeon controlled filters for increased safety and differentiated viewing + Pre-assembled packs with one-step, 43 second primingNew ESA Technology + One pack, one interface reduces steps in theatre+ Enhanced blade design for easier insertion + Simple transition from phaco to vitrectomy+ Exceptional cannula retention in the eye increases efficiency+ Sclerotomy design makes tighter wounds Designed to fit your needsDual-linear technology + Sleek footprint maximises space in theatre+ Simultaneous parameter access allows better + Tru-Link offers rapid communication with surgeon control technical assistance+ Adds useful functionality requiring less mode changes+ Wireless footpedal eliminates cord clutterSingle Use Needles and CannulaeBausch + Lomb carry a full These include: Lacrimal Cannularange of sterile needles Anaesthesia Needle Tapered 19–23 gauge and curved 26 gaugeand cannulae for use in Retrobulbar and Peribulbar in 23 and 25 gauge Visco Cannulaophthalmic procedures. Anterior Chamber Needle 23 and 27 gauge 23, 25, 27 and 30 gauge Silicone Capsule Polisher 27 gauge Irrigating Cystotome 23, 25, 27 and 30 gauge All are conveniently packed in boxes of 5. Hydrodissection Cannula Should you require more information, please ask 25 gauge your local B+L Surgical Equipment Specialist.
4 MagazineEducation Four decades of Minims ® By Anne Davies, Minims® Brand Manager
5 Education The re-use of Minims® – an unacceptable practice? Minims® are designed and licensed for single use. By “single use” it is meant that after they have been used once they must be discarded, and not stored for re-use. Over recent years an ongoing debate about re- A short history of Minims® use of unit dose eye drops has taken place in the ophthalmic press, (see “Why Minims?”). The debate Why Minims®? boils down to the question of risk management; in The re-use of Minims® – an unacceptable practice? fact it relates directly to the original ethos behind the creation of the Minims® range (see “A short history of Minims®”, above). A short history of Minims® Unit dose eye medicines exist because there is a The Minims® product range of unit-dose and undesirable microbial contamination of need (1) to minimise the risk of cross-infection and preservative-free eye drops was created in nonsterile drugs and adjuvants”. The Committee (2) to treat those who cannot tolerate preservatives. response to a UK government report calling recommended that this problem be given close Unit dose medicines are, however, more costly and for an improvement in the safety of eye drops1. attention by the WHO. This was quickly followed use more packaging than multi-dose equivalents, This occurred in an environment of increasing by a DHSS working party report “Preservation which has led some to question whether the concern about the safety of non-sterile medicines. of sterility in ophthalmic presentations used in microbial risk is sufficiently high to justify the single In particular, two outbreaks of eye infection at hospitals”1, which concluded that, in order to use of unit dose preparations. Birmingham & Midland Eye Hospital in 19642,3 reduce the incidence of contaminated eye drops Dr Pierre Rautenbach, had sparked a number of publications calling for and cross-contamination between patients, Specialist Registrar in sterile single-use eye drops. These prompted there was a need for a presentation suitable for Ophthalmology from the the publication of a supplement to the British single use only and which would remain sterile Southwest Peninsula Deanery Pharmaceutical Codex (BPC), in 19664, up to the point of use. As a result, the Minims® in Devon and Cornwall, providing the first national regulations for liquid product range was launched by Smith & Nephew observed the re-use of eye preparations. These were subsequently Pharmaceuticals in October 1969, providing a diagnostic Minims® in adopted by the Department of Health & Social double-wrapped range of single-use preservative- ophthalmic practice and Security (DHSS) in the 1975 document that still free ophthalmic preparations. recently performed a study applies today5. The Minims® eye drop range was sold to Dr Pierre Rautenbach to evaluate both the risk and In its 1969 report, the World Health Organisation Laboratoire Chauvin in 1993, and Bausch + cost of use7. He concluded that “The cost of a PFM (WHO) Expert Committee on Specifications Lomb acquired Laboratoire Chauvin in 2000. (Proxymetacaine 0.5% fluorescein 0.25% Minims® for Pharmaceutical Preparations6 noted that The portfolio continues to play a central role in unit) is about 1% of the cost of a single outpatient there had been “growing concern with excessive ophthalmic practice. attendance. In the interest of patient safety, our study suggests using PFM for a single application only”. Other studies have also documented the risks of re-using unpreserved eye drops8, 9. Common sense tells us that some medicinal preparations are more likely to support spontaneous contamination than others. Some studies have shown, for example, that artificial tear and steroid preparations are more likely to support microbial growth and that alkaloid and anti-bacterial preparations are less likely to do so10. Why Minims®? All Minims® are preservative-free, thereby Given this situation, a blanket recommendation for avoiding the sensitivities caused in some re-use of unpreserved eye drops over a particular Minims® benefits patients by preservatives. The use of unit dose time period after first opening is clearly untenable. Preservative-free eye medicines reduces the risk of cross- contamination because a sterile unit is used for For unpreserved units that are re-used by the same All Minims® are preservative-free and therefore avoid preservative-related each treatment. The units are double-wrapped patient, however, there could be a justification inside a sterile blister, providing sterility at the for a less stringent application of the single use side-effects1 point of use. guideline. In the absence of national guidelines on Single dose use of unpreserved eye drops, many hospitals have The design of Minims® unit dose dropper is Designed and licensed for single use, also noteworthy. Unlike single-dose units with a implemented their own timescales for re-use by the reducing the risk of cross-contamination2 tear-off cap, which can leave a jagged dropper same patient. If implemented, a national guideline Sterile tip of torn plastic with potential to traumatise the would need to be supported by data specific to Heat-sterilised or aseptically manufactured eye surface3, the newly opened Minims® unit has the medicines concerned, and accompaniedUK/MIN/10/002 October 2010 Double wrapped a smooth moulded surface. The Minims® cap by a statement that the unit must not be shared is used to preserve sterility until opening, after between individuals. In the meantime, Bausch + Sterile dropper inside sterile over-wrap, which the unit is discarded. Lomb continues to promote its “One Minims providing sterility at the point of use 1 Baudouin C. Allergic reaction to topical eyedrops. Curr Opin Allergy unit, One patient” campaign in eye units across Colour-differentiated packaging Clin Immunol 2005; 5: 459–63. 2 Rautenbach P, et al. Eye (Lond). The reuse of ophthalmic Minims: the country. This policy, in conjunction with the Designed to minimise the risk of an unacceptable cross-infection risk? 2010 Jan;24(1):50–2. supportive and expanding evidence base, is dispensing errors 3 Macdonald EC, Lockington D, Roberts F, Tetley L, Ramaesh K. Unit-dose dispenser tips: a potential source of ocular injury. Br J Ophthalmol. 2010 resulting in the practice of sharing Minims® units Jan;94(1):136–7. between patients steadily being eliminated.
6 Magazine Education In conclusion, the Minims® range of unit dose eye 4 Jolly S, ed. British pharmaceutical codex. 8th ed. London: Pharmaceutical Press, 1963 (Suppl) 1966. medicines was specifically designed to provide preservative-free treatments with reduced risk 5 Department of Health and Social Security. Preservation of sterility in ophthalmic preparations in hospitals. Health Service Circular HSC (IS) 122. London: DHSS, 1975. Forthcoming of cross-contamination, and this central purpose should not be compromised by non-compliant 6 WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-second report. Genève, Organisation mondiale de la Santé, 1969 (OMS, Série de Rapports techniques, No. 418). Geneva, World Health Ophthalmic practices such as re-use. Organization, 1969 (WHO Technical Report Series, No. 418). 7 Rautenbach P, et al. Eye (Lond). The reuse of ophthalmic Minims: an unacceptable cross-infection risk? 2010 Jan;24(1):50-2. Inflammation 1 Working Party on Sterility in Ophthalmic Fluids. Preservation of sterility in ophthalmic presentations used in hospitals. HM (69) 86, November 1969 – available from the National Archives. 8 Rahman MQ, Tejwani D, Wilson JA, Butcher I, Ramaesh K. Microbial contamination of preservative free eye drops in multiple application containers. Br J Ophthalmol. 2006 Feb;90(2):139–41. meetings 2 British Medical Journal Editorial. Infections at Birmingham & Midlands Eye 9 Qureshi MA, Wong R, Robbie SJ, Qureshi KM, Rowe C, Leach J. Contamination Hospital. Br Med J. 1965 November 27_2(5473) 1316. of single-use Minims eye drops by multiple use in clinics. J Hosp Infect. 2006 3 Ayliffe GA, Barry DR, Lowbury EJ, Roper-Hall MJ, Walker WM. Postoperative Feb;62(2):245–7. Epub 2005 Nov 11. Monday 15th November 2010 infection with Pseudomonas aeruginosa in an eye hospital. Lancet. 10 Oldham GB, Andrews V. Control of microbial contamination in unpreserved 1966 May 21;1(7447):1113–7. eyedrops. Br J Ophthalmol. 1996 Jul;80(7):588–91. Cornea and Glaucoma Update 12:30pm – 17:30pm Mary Ogilvy Lecture Theatre St Anne’s College 56 Woodstock Road, Oxford, OX2 6HS Chair: Mr John Salmon, John Radcliffe Hospital, Oxford Accredited with 2.5 CPD points. A Certificate of Attendance, for use as part of a PDP, will be provided after the meeting. This meeting is organised and sponsored by Bausch & Lomb UK Ltd. Please register online at www.ocularmeetings. org (password: eyes) Alternatively, please reply by email or telephone. Email: email@example.com using ‘November 15th Cornea and Glaucoma event’ in the subject heading Conference enquiry line: 01462 744047 Register your interest for the following 2011 meetings at www.ocularmeetings.org (password: eyes) Wednesday 23rd March 2011 Microbiological risks of re-using unpreserved eye drops: where do you stand in the debate? A useful overview of the literature relating to microbiological risks associated with single dose 17:30 – 19:30 preservative-free eye drops was recently provided by Ophthalmic Pharmacist Lucy Titcomb1. Royal Society of Medicine, London There have been attempts to generate data in support of the multiple use of unpreserved eye drops2, Chair: Mr Carlos Pavesio, and, conversely, studies to demonstrate the microbiological risks, both bacterial and viral, of doing 3, 4 Moorfields Eye Hospital so5, 6, 7, 8. There has also been a call to embrace better technology for the benefit of patients and to apply a long term positive approach to health spending, as opposed to a cost-cutting approach9. Agenda to be arranged We encourage readers to evaluate both sides of the argument for themselves, and to contact us with your views at academyUK@bausch.com Thursday 14th April 2011 1 Titcomb L 2010. Are quality standards being reduced as eye drops are classified as devices? Pharmaceutical Journal 284:633–638 2 Marchese A, Bozzolasco M, Gualco L, Schito GC, Debbia EA. Evaluation of spontaneous contamination of ocular medications. Chemotherapy. 2001 Jul–Aug;47(4):304–8. 3 Su CY, Yang YC, Peng CF, Hsu YC, Lin CP. Risk of microbial contamination of unit-dose eyedrops within twenty four hours after first opening. AM & PM seminars J Formos Med Assoc. 2005 Dec;104(12):968–71. 4 Somner JE, Cavanagh DJ, Wong KK, Whitelaw M, Thomson T, Mansfield D. The precautionary principle: what is the risk of reusing disposable drops in routine St John’s College, CambridgeUK/MIN/10/002 October 2010 ophthalmology consultations and what are the costs of reducing this risk to zero? Eye (Lond). 2010 Feb;24(2):361–3. Epub 2009 Jun 12. 5 Rautenbach P, et al. Eye (Lond). 2010. The reuse of ophthalmic Minims: an unacceptable cross-infection risk? Jan;24(1):50–2. Chair: Mr M Rajan, Addenbrookes Hospital 6 Qureshi MA, Wong R, Robbie SJ, Qureshi KM, Rowe C, Leach J. Contamination of single-use Minims eye drops by multiple use in clinics. J Hosp Infect. 2006 Feb;62(2):245–7. Epub 2005 Nov 11. Agenda to be arranged. 7 Rahman MQ, Tejwani D, Wilson JA, Butcher I, Ramaesh K. Microbial contamination of preservative free eye drops in multiple application containers. Delegate fee £75. Br J Ophthalmol. 2006 Feb;90(2):139–41. 8 Hamada N et al. Nosocomial outbreak of epidemic keratoconjunctivitis accompanying environmental contamination with adenoviruses. J Hosp Infect. 2008 Mar;68(3):262–8 9 Lockington D, Dutton GN. Eyes, economics and the environment: should green issues drive changes in ophthalmic care? – No. Eye (Lond). 2010 Aug;24(8):1312–4.
7 EducationThe Akreos MICS Designed to Minimise PCO Award-Winning Design Recognised for its innovative design, the Akreos MICS Lens received the prestigious Gold Award in 2008 at the Medical Design Excellence Awards (MDEA).The Akreos MICS, like Designed to Minimize PCOits Akreos predecessors,is composed ofbiocompatible, hydrophilic, Angled haptics to maintain placement Haptics reinforced for consistent and against posterior capsule controlled pressure on the capsuleacrylic material, whichmakes it incredibly strongyet flexible enough tobe inserted through a1.8mm incision. Continuous 360° 90° edge angle for optimum cell blockage square edge including the haptic-optic junctionThis award winning design uses the sameanti‑PCO properties of the Akreos AO:The 360° x 90° anti‑PCO barrier and squareedge design. The haptics on the conforming tips Three lens diameters for “best-fit” in the capsular bagare also angled at 10° to improve contact with Eye Type Myopic Emmetropic Hyperopicthe posterior capsule. Axial Length -26 -24 to -25 -23 Optic Size 6.2mm 6.0mm 5.6mm Overall Length 11.0mm 10.7mm 10.5mm Diopter Range 0 to +15D +15.5 to +22D +22.5 to +30D The incidence of YAG laser posterior capsulotomy after implantation of the Akreos MI60 lens implant A. Castillo & M. Wakefield Purpose: To evaluate the rate of posterior + Type of implant inserted rate was determined. 622 patients capsular fibrosis sufficient to merit YAG + Side underwent cataract surgery in the 4 month laser treatment after implantation of an period between mid July 2008 and mid Akreos MI60 lens implant to determine + Weather posterior or combined October 2008. the mean time interval between posterior and anterior capsulotomy Conclusion: The MI60 lens implant was implantation and laser treatment. + Any complications of surgery adopted as the implant of choice by the Mr Andrew Castillo Setting: Department of Ophthalmology, FRCOphth. + Any pre/operative risk factors department at the same time as a change Lincoln County Hospital, Lincoln, LN2 over to micro incision cataract surgery. Results: 217 patients underwent YAG 5QY, UK Previously published data has shown laser treatment over the 4 month period Methods: Data collected prospectively excellent refractive outcomes from the of the data collection. 54 patients had of all YAG laser capsulotomies done an Akreos MI60 lens implanted. The surgery. This study shows a YAG laser in the department over a 4 month mean interval between surgery and capsulotomy rate of 8.6% with micro period between September 2009 and YAG capsulotomy was 13.5 months. incision cataract surgery combined with an December 2009. The number of procedures with MI60 Akreos MI60 lens implant with a median implant carried out during the relevant interval of 13.5 months between surgery + Date of YAG laser treatment and laser. period was determined from theatre + Date of initial surgery records and a YAG laser capsulotomy ESCRS Abstract, Paris 2010
8 MagazineScience + TechnologyDual Linear ControlDelivering foot pedal versatilityThe use of a foot pedal in theatre to control the surgical parameters of aphacoemulsification procedure (cataract removal) is accepted as a part ofall modern techniques. However, many surgeons remain unaware of the manyfoot control options available to them on the Bausch + Lomb phaco platforms;Millennium® and Stellaris®. We take a look at the most versatile of these,dual linear control, and its application in this article.The Conventional Foot PedalConventional foot pedals move in a sequentialup and down movement (Pitch). On most phacomachines depressing the foot pedal will first engage Reﬂuxirrigation into the eye followed then by a gradually Irrincreasing aspiration level. By the time the footpedal is depressed into the third pitch position, tocontrol ultrasound, the aspiration rate has achieved Vac 50its maximum preset rate. It remains fixed at thismaximum level whilst ultrasound is being delivered.On vitreoretinal machines, depressing the foot Vac 50pedal activates the cutter and, whilst you have linear U/S 1-50control of aspiration, the cutter is fixed at its presetrate and can only be toggled on or off.Dual LinearBausch + Lomb’s dual linear foot pedals providesurgeons with a rapid response to all eventualitiesduring surgery owing to the simultaneous, butindependent, linear control of fluidics and phaco ‘Dual Linear has everything you wantpower or fluidics and cut rate offered in the twoplanes of foot pedal movement. This design at the flick of a pedal. You can deal withoffers enhanced control sensitivity becauseof the increased range of travel for aspiration any grade of cataract on one setting.’and ultrasound. Brian Little, Moorfields Eye HospitalThis control can be configured in more that oneway. Here are some of the options:Dual Linear in Phaco SurgeryAspiration on YawIn this setting, the pitch movement of the pedal Reﬂux Irris set up conventionally with irrigation and thenaspiration gradually building to a preset level asyou move into ultrasound delivery. However, this Vac 50 Vac 50–200maximum setting is usually lower than would beset on a conventional pedal. If more aspiration isrequired, whilst aspirating or delivering ultrasound,kicking the pedal out to the side (Yaw) will allow Vac 50you to increase it up to a second, higher preset U/S 1–30aspiration limit.
9 Science + TechnologyThis form of dual linear control has benefitsfor surgeons and juniors who are considering Advantages of Dual Lineara move to, or who are already using, a choptechnique. It provides for more control as you + Improved controlcan use ultrasound and low aspiration to imbedthe phaco needle and then utilise the yaw to + Simultaneous, independent linear controlincrease aspiration and hold on to the piece of – Aspiration and Cut Ratenucleus whilst you perform your chop. – Aspiration and Ultrasound DeliveryAdditionally, the first segment of nucleus in a phaco + Can be customised to surgeon techniquechop procedure may call for access to higheraspiration levels as, with no sculpting taking place, + Surgeon can alter parameters without asking operating staffthere is less space for manoeuvre.Ultrasound on YawIn this setting, rather than the usual three positionsin the pitch movement there are only two positions,irrigation and irrigation with linear aspiration.Access to linear ultrasound is achieved via the yaw Reﬂux Irrmovement of the foot pedal. This setup carries thebenefit of allowing you to use any combination ofaspiration and ultrasound and is the most versatile Vac 10–200 U/S 0–30option for dual linear.The advantages of this configuration can be seenwhen removing soft cataracts as they can essentiallybe aspirated from the capsular bag, using smallbursts of ultrasound if needed. It is also extremelyuseful as an epinucleus setting for the same reason.Additional Dual Linear capabilities in Combined MachinesVitrectomy Cutter on YawThe concept of dual linear is the same for combinedmachines. In this setting, linear aspiration is set upon the pitch but, at any point, you can gain linear Reﬂuxcontrol of cut rate by using the yaw movement. Vit 2500–5000 Vac 0–250Aspiration on YawThe inverse configuration of the above is alsoavailable, offering the same versatility but with linear Reﬂuxcut rate on pitch and aspiration on the yaw.We have provided both variations for vitreoretinal Vac 0–250procedures to suit your personal preference.Each configuration affords you control of bothparameters separately; so you have the flexibilityto reduce the cut rate and increase the aspiration Vit 2500–5000for core vitreous removal and then increase the cutrate and reduce the aspiration for shaving close tothe retina.
10 MagazineNew InnovationInnovative Lens CareInspired by the Biology of the Eye™Report from a European Roundtable Meeting of Eye Care ProfessionalsIn developing Biotrue™ multi-purpose solution, scientists Biotrue™ Multi-purposeat Bausch + Lomb took inspiration from the best source – solution:the human eye itself. The result is a unique multipurpose + Matches the pH of healthy tearslens care solution inspired by the eye’s biology and + Utilises a lubricant found in the eyesnaturally-occurring processes. + Keeps beneficial tear proteins activeTo assess the performance of Biotrue™, a group ofleading eye care practitioners (ECPs) from acrossEurope were offered the opportunity to try theproduct with some of their patients and give theirinitial feedback at a roundtable meeting held inManchester in the UK. This report summarises thepresentations given at the meeting and presents anoverview of the participants’ feedback.Bringing bio-inspirationto contact lens careDr Peter Vukusic, Associate Professor at theUniversity of Exeter School of Physics, and anexpert in bio-inspired optical design, explains thatbio-inspiration is a discipline that studies and learnsfrom nature’s best ideas to generate breakthroughproducts and technologies. Examples of bio-inspired design in the modern world include:Aerodynamic cars inspired bythe boxfishThe boxfish has a large, yet streamlined, body thatallows it to swim very fast. This design inspired anew car that creates incredibly low levels of drag.Swimsuits inspired by the structureof shark skinThe inspiration for modern swimsuits came fromthe outer structure of shark skin, allowing swimmersto move through the water more easily.Velcro® inspired by the burdockplant seedThe inspiration for Velcro® came from the burdockplant, replicating the hooks of the seeds and theloops of wool, connecting two surfaces together ina non-permanent way.In the ophthalmic field, accommodating intraocularlenses have been designed to mimic the naturalcrystalline lens as closely as possible, movingwithin the eye and allowing patients to see at near,intermediate, and distance with equal clarity.Bio-inspiration can lead to the development ofinspired products across all segments of healthcare,and eye care should be no exception. Scientists L’Oreal has used inspiration from biological photonic systems to design a series of photonic-based cosmetics (Image courtesy of L’Oreal).
11 New Innovationhave already applied bio-inspiration to contactlens materials to mimic the properties of the ocularsurface, and formulated eye drops to relieveocular dehydration based on the physiology ofthe eye. Understanding the human tear film andthe components of the tears can also inspire theinvention of new designs that offer optimal solutionsfor contact lens wearers.Biotrue™ has been developed using three bio-inspired innovations that provide contact lenswearers with a combination of benefits. Matchingthe pH of healthy tears, utilizing the eye’s naturallubricant, hyaluronan (HA), and keeping certainbeneficial tear proteins active, all combine to offerpatients a solution that works like their own eyes.The anticipated benefits to consumers of thesebio-inspired innovations include excellent comfort onlens application, minimal physiological change whenintroduced to the eye, all-day lens moisture, comfortand clear vision. From their initial impressions of Biotrue™ solution utilises a lubricant found in the eyeBiotrue™, the roundtable participants agreed thatthese goals had been met, and that bio-inspiration Each molecule of HA can hold up to 1000 times its own weight in water17, 18, helpinghad indeed created a truly innovative product that to keep the corneal epithelium hydrated and to stabilise the preocular tear film19.contributed to an excellent lens wearing experience. Biotrue™ is the first FDA-cleared multi-purpose solution containing hyaluronan (HA) – the same moisture-loving molecule found naturally in the eye19, 20. Caroline Christie from City University in London drops. From the feedback we have had at this‘Most of my patients said presented an overview of the benefits and uses of HA in the eye, saying: ‘HA contributes to the meeting, it would appear that the addition of HA to a contact lens solution leads to a good level ofthey could really feel the comfort of this product. It’s fluid-loving properties are exactly what we want, which is why it is lens comfort even late in the day.’benefit to their eyes after already being used in artificial tear products and contact lens rewetting drops.’ ‘I have had really good feedback from my patients about lens comfort with Biotrue™. Myusing Biotrue™’ As Ms Christie explained, the HA in Biotrue™ patients have said they can wear their lenses all day without getting dry eye sensations. For me, forms a free-flowing, hydrating network on the this is the most important attribute of the product.’Dr José Manuel Gonzàlez-Méijome lens surface and, by naturally attracting water Wim Werrelman, The Netherlandsfrom Portugal. molecules, the HA helps to envelop lenses in ‘As a well-known natural moisture-agent, HA a moisture-rich cushion. Studies assessing the promotes lens hydration during the day. This hydrating benefits of Biotrue™ have found that should lead to better end-of-day comfort‘I think the concept of bio-inspiration will appeal the HA remains on both hydrogel and siliconeto a particular group of patients.’ and easier removal of the lens at night.’ hydrogel lenses for up to 20 hours (Figure 3)‡, José Manuel Gonzàlez-Méijome, PortugalChristine Purslow, UK helping to provide moistness and all-day comfort. ‘With Biotrue™, you can feel that the liquid is‘Some patients will certainly be interested in the Ms Christie continued, ‘We know HA is an smoother. Some of my patients reported thatmessage that the product is more natural, but the incredibly useful moisturiser that occurs naturally their lenses felt softer, which was really good.’main reason most will want to use it will be based in the eye and we know it works well in dry eye Øyvind Krogh, Norwayon its performance.’ Figure 3. Percentage of hyaluronan that remains on ‘HA is my favourite treatment for patients whoIan Cameron, UK silicone hydrogel and hydrogel lenses over time complain of dryness in contact lens wear.‘This product looks different and it is different, 100 I certainly think that the HA in % hyaluronan remaining on lenses Silicone hydrogel lenses Hydrogel lenses Biotrue™ may contribute toand the planned consumer marketing behindit is amazing. I think patients will be driven in.’ 80 the better end-of-day comfort reported by my patients.’Christine Purslow, UK 60 Stefan Schwarz, Germany‘The bio-inspiration concept is a good one. 40 ‘What’s novel about thisHaving a product that promotes a natural eye product? The inclusion ofenvironment is a strong message’. 20 HA is novel – it’s a reallyJosé Manuel Gonzàlez-Méijome, Portugal easy sell because we know 0 that it works in artifical tears.’‘This is a great opportunity for Bausch + Lomb Initial 5 hours 10 hours 15 hours 20 hours Ian Cameron, UKand eye care practitioners to re-establish the MPScategory with a really positive message. Biotrue™ ‡Results of in vitro study performed to evaluate the rate of release of sodium hyaluronan (HA) from both traditional hydrogel (Bausch + Lomb SofLens®38 contact lenses, SofLens® For Astigmatism lenses, and Vistakon ACUVUE® 2) and silicone hydrogel contactis very different to hydrogen peroxide, and it is lenses (Bausch + Lomb PureVision® contact lenses, Vistakon ACUVUE® Oasys, Vistakon ACUVUE® Advance, CIBA Air Optix®,important we get this message across.’ CIBA Night & Day, and CooperVision Biofinity®) over a 20-hour time period. Lenses were placed in a Bausch + Lomb standard lens cases and soaked overnight in Biotrue™ prepared with HA tagged with fluorescein. Hank’s balanced salt solution (HBSS) wasChristine Purslow, UK dripped over the lenses at a rate that approximates tear film secretion in the human eye as determined by Reddy I, et al. Ocular Therapeutics and Drug Delivery. Technomic Publishing Co. 1996; 174. The solution that rinsed off the lenses was collected hourly‘This is a good product. A safe product.’ over a 20-hour period and the fluorescence intensity was detected. A standard curve was used to determine the concentration of fluorescein-tagged HA present in each rinse solution. The extended presence of fluorescein-tagged HA in the rinse solutionsWim Werrelman, The Netherlands indicates the percent of HA retained on the lens surface.
12 MagazineNew InnovationBiotrue™ solution and contact lens solution optimisation Osmolality, viscosity, and surface tension have also been optimised to match healthy tears (Table 1).A healthy balanced tear film is essential to ‘smooth out’ the subtle imperfections of the Why should this matter? Well, according tosurface of the eye, to nourish the outer corneal structure, and to lubricate and protect Dr Purslow, such solution optimisation across thethe corneal epithelium. A variety of different factors contribute to the composition and physical spectrum is likely to translate into a numberhealth of the tear film including pH, osmolality, viscosity and surface tension. According of significant benefits for contact lens users. Studiesto Dr Christine Purslow from the Contact Lens and Anterior Research Unit at Cardiff have shown that if the pH of a contact lens solutionUniversity, the ideal multipurpose contact lens solution should match all four of these is higher or lower than the healthy tear pH, stinginghealthy tear performance measures. and discomfort may be reported9, 10. pH is also important to maintain the antimicrobial efficacy‘We know from the literature that tears are slightly Biotrue™ solution matches of disinfectants such as those used in Biotrue™.alkaline, with a pH of around 7.51 , Dr Purslow the pH of healthy tears Osmolality is important as it affects osmotically-told the meeting. ‘However, contact lens wearers driven fluid transport11, with higher than normal tearhave a tendency to develop an acidic pH due to Biotrue™ has been uniquely formulated to match the pH of healthy tears – thus maintaining the eye’s osmolality being associated with dry eyes. Healthyhypoxic metabolism and accumulation of CO2 tear viscosity and surface tension maintain comfortbehind the lens2, so the ideal contact lens solution natural conditions (Figure 1).* upon blink and enable the tear film to spread moreneeds to be slightly alkaline and to have the ability It also contains two buffering agents (sodium readily across the eye.to buffer against acidic and alkaline challenges from borate and boric acid), which provide chemicalthe environment.’ stability and help to resist pH changes3. ‘With Biotrue™ we have a solution that nicely matches all the performance characteristics of healthy tears including pH, osmolality, viscosity and surface tension,’ said Dr Purslow. ‘For me, this is pH range of healthy OPTI-FREE® what makes Biotrue™ truly unique.’Figure 1 tears (7.3–7.7) RepleniSH 6.6 6.8 7.0 7.2 7.4 7.6 7.8 8.0 ‘Having the same pH Clear Care® (neutralised) COMPLETE® (Easy Rub) Biotrue™ OPTI-FREE® Express as healthy tears should translate into comfortTable 1. Osmolality, viscosity, and surface tension of Biotrue™ compared to various multi-prupose solutions4. on lens application.’ Osmolality, Surface José Manuel Gonzàlez-Méijome, mOsm/kg Viscosity, Tension, Portugal Test Solution pH SD SD cP SD mN/m SD Healthy tears 7.3–7.75 244–3446 1–107 42–468 AQuify ® 7.21 0.01 310 1 1.50 0.01 45.5 0.5 COMPLETE MPS ® 7.19 0.01 392 1 1.20 0.02 49.8 0.3 * Results from a pH comparison study of three separate lots of Easy Rub Formula Biotrue™, CIBA Clear Care®, AMO COMPLETE® Easy Rub, Alcon OPTI-FREE® Express, and Alcon OPTI-FREE® RepleniSH. OPTI-FREE® RepleniSH 7.83 0.02 272 2 1.29 0.01 39.2 0.6 The pH of the test solutions was determined using a Fisher Scientific accumet excel XL25 pH meter. Five pH measurements OPTI-FREE EXPRESS ® 7.82 0.01 220 1 1.13 0.03 39.9 0.6 for each solution were taken, averaged, and evaluated in comparison to the pH range of healthy tears, as determined by Biotrue multi-purpose ™ 7.50 0.02 285 1 1.15 0.02 44.4 0.2 Adler’s Physiology of the Eye, Clinical Application. C.V. Mosby solution Company, 1981, as well as the mean pH of tears as determined by Yamada M et al. Current Eye Research 1997; 16:482–486.Biotrue™ solution keeps beneficial tear proteins activeThe human tear film contains from microbial infection. Tear film as Dr Philip Morgan from the Universityapproximately 500 different proteins; proteins quickly deposit onto contact of Manchester explained, there is goodfour are present at high concentrations lens materials during wear, which has evidence that certain tear proteins –(Table 2)12, 13 and lysozyme, lactoferrin historically been viewed negatively particularly the antibacterial enzyme,and secretory IGA offer protection from a clinical perspective. However, lysozyme – play a vital role in attacking a variety of microbes, including speciesTable 2. Major tear proteins12* of Streptococcus and Staphylococcus. Protein Molar mass (daltons) Concentration (mg ml-1) ‘We need to start think differently in the development of contact lens care products, Lysozyme 14,000 2.07 specifically related to proteins in the tear film and Lipocalin 17,500 1.55 protein deposits on contact lenses,’ Dr Morgan urged participants. ‘These proteins are there for Lactoferrin 90,000 1.65 a reason and potentially, if we can keep them in Secretory IgA 385,000 1.93 their native form during contact lens wear, we may offer greater protection for the eye against*Other tear film protein concentrations are <0.1 mg/ml. microbial infection.’
13 New InnovationLysozyme: a natural disinfectantLysozyme was discovered by Alexander Flemingin 1922. It is a potent antibacterial enzyme thatfunctions by hydrolysing bonds in bacterialcell walls, particularly those of gram positivebacteria. To function optimally, lysozyme mustbe conformationally intact in order to bind to thebacterial cell walls14. However, as Dr Morganexplained, many external factors can alter theseproteins to a state of denaturation, therebyreducing their bactericidal benefits.Figure 2. Percentage of protein activity for Biotrue comparedto various other contact lens products 100 90.1% COMPLETE® (Easy Rub) OPTI-FREE® RepleniSH 80 OPTI-FREE E®xpress% protein activity 60 Clear Care® Biotrue™ 40 20 Biotrue™ solution provides unsurpassed disinfection 5.5% 4.3% 4.0% 6.9% Biotrue™ combines its unique bio-inspired innovations with a dual disinfection system. 0 The combination of polyhexamethylene biguanide (PHMB) and polyquaternium-1 (PQ-1) provides excellent disinfecting power. Biotrue’s pH optimises the environmentTo help prevent denaturation, Biotrue™ surrounds for the effectiveness of these two disinfectants, and this multifaceted approach hasand protects tear proteins such as lysozyme, resulted in Biotrue™ outperforming other multipurpose solutions in FDA/ISO stand-allowing them to maintain their inherent alone testing. Biotrue™ has also shown to be highly effective in real-world clinicalantimicrobial activity for longer. isolate testing, and Acanthamoeba elimination studies.A recent study found that Biotrue™ can prevent ‘Bausch + Lomb has adopted a very comprehensive approach to testing the disinfection power oflysozymal denaturation, maintaining over 90% Biotrue™,’ said Caroline Christie from City University in London. ‘They have gone way beyond what isof the protein’s activity under experimental required by the regulatory authorities and shown efficacy across a broad range of clinically importantconditions, which is over 13 times more than infectious agents.’other multipurpose solutions (Figure 2)15.†In addition to preventing denaturation, Biotrue™ FDA/ISO stand-alone testing achieve a 3-log (99.9%) reduction of Serratiaalso helps remove denatured proteins that have marcescens, Pseudomonas aeruginosa, andbonded to the surface of contact lenses. FDA and ISO stand-alone testing quantifies the disinfection efficacy of multipurpose solutions Staphylococcus aureas.‘Studies in our own laboratory have confirmed 16 based on log reductions of established challenge With only a 4-hour soak, Biotrue™ providedthat components of the Biotrue™ solution can help organisms including fungi and bacteria. In order exceptional disinfection compared to other lensmaintain the structural and functional integrity to meet testing standards, solutions must achieve care solutions (Figure 4), even when organicof both lysozyme and lactoferrin and almost a 1-log (90%) reduction of Candida albicans soil was added to create a more rigorouscompletely prevent denaturation,’ said Dr Morgan. and Fusarium solani. For bacteria, solutions must test condition.§The roundtable participants agreed that this wasa novel and attractive bio-inspired feature of Figure 4. Mean log reduction of organisms tested using FDA/ISO standalone testing.Biotrue™ that should translate into clearer andmore comfortable lenses.‘My patients told me that, after using Biotrue™, Fusarium solani 4.6 4.1 Candida albicansthey had better end-of-day comfort and clearer Serratia marcescensvision,’ said Stefan Schwarz from Germany. ‘I think Pseudomonas aeruginosait is the combination of all the ingredients togetherthat makes this product unique.’ Biotrue™ 4.3 Staphylococcus aureus 4.7‘I really like the idea that, with Biotrue , ™ Numbers represent mean logthere may be lysozymal protection.’ agreed 4.7 unit reduction*Professor Giancarlo Montani from Italy. *Biotrue™ and Clear Care®‘I think it’s really good news that Biotrue™ keeps 3.2 3.9 1.7 2.1 results from separate in vitro 0.9the tear film proteins active.’ José Manuel 1.8 0.3 3.2 4.7 4.2 studies performed following identical test procedures ® ® ® oPTi-FrEE oPTi-FrEE CoMPLETE ®Gonzàlez-Méijome, Portugal replenis SH 3.7 Express 3.2 Easy rub Clear Care 3.6 4.6 3.6†Results of in vitro study evaluating the ability of various 4.6 4.6 4.6 4.6 4.2multi-purpose solutions (Biotrue™, AMO COMPLETE® EasyRub, Alcon OPTI-FREE® Express, and Alcon OPTI-FREE®RepleniSH) to stabilize lysozyme in the native form under chemicaldenaturation conditions that typically denature lysozyme. Solutions § Results of in vitro study following FDA/ISO stand-alone procedure for disinfecting products. Tests against all solutions werecontaining lysozyme were exposed to sodium dodecyl sulfate. modified with organic soil added to create a more rigorous test condition. Primary criteria for effective disinfection are defined asSubsequently, activity against Micrococcus luteus was evaluated a reduction in the number of bacteria by a minimum of 3 logs (99.9%) and a reduction of mold and yeast by a minimum of 1 logto assess the ability of solutions to protect lysozyme. Clear Care® (90%) within the recommended disinfection time. Graphs depict mean log reduction measured after manufacturers’ recommendedresults are from a separate in vitro study performed following disinfecting time (soak only). Clear Care® results from separate in vitro study performed following identical test procedures.identical test procedures. Statistically significant at p<0.0001.
14 MagazineNew InnovationClinical isolate testingClinical isolates are microbial strains collectedfrom clinically worn lenses, lens cases, andinfected eyes. Clinical isolate testing with Biotrue™has demonstrated that the product achievesconsistently high log reductions against S. aureus,methicillin-resistant S. aureus (MRSA), andF. solani,** as well as delivering effective eliminationof Acanthamoeba polyphaga and Acanthamoebacastellanii trophozoites and cysts.††‘Biotrue™ has this unique combination of two highlyeffective disinfection agents, and this is a nicecombination that works synergistically across thespectrum’, Caroline Christie said. ‘I have to say that,based on the evidence I have seen on this product,it really does provide superior disinfection.’The roundtable participants agreed that, althoughcomfort was very important with a multipurposesolution, the level of disinfection offered was critical.‘Proven disinfection is the most important attributeof any MPS for me,’ said Dr Evelyne Le Blond fromFrance. ‘I like the fact that Biotrue™ has been testedin real life conditions, and this is the best efficacy ECP and patient experiences of Biotrue™ solutionagainst fungi I have ever seen.’ Dr Christine Purslow The ECPs who attended this meeting difficulty with lens removal. This was a great result.’from the UK agreed: ‘The pH and HA components José Manuel Gonzàlez-Méijome, Portugal had the opportunity to evaluate Biotrue™of Biotrue™ are an added bonus, but it’s the efficacy with some of their patients and to shareof the product that will make me choose it’, she said. The ECP experience their experiences of using the product.‘Bausch + Lomb is among the first companies Feedback was universally positive, with all The ECPs reported that they were very happy with theto go beyond the FDA testing standards’, noted attendees endorsing the potential benefits overall visual quality their patients were able to obtainDr José Manuel Gonzàlez-Méijome from Portugal. it will bring both to their patients and while using Biotrue™ and that the clinical performance‘The fact that Biotrue™ is effective against both their own clinical practices. Many of the of the solution had met – and in cases exceeded – theirAcanthamoeba and MRSA is excellent as these ECPs said they would be recommending expectations. Participants felt that the combinationare both significant public health problems.’ Biotrue™ as a first-choice lens care solution of improved lens comfort and the dual disinfection‘It’s a simple message. In my opinion Biotrue™ as soon as it is available in their countries. power with Biotrue™ was a compelling one, and thatis safe and is the most comfortable of all MPS they would have no hesitation in recommending the The patient experience product to their patients.available. I’m convinced of this.’Wim Werrelman, The Netherlands The meeting participants were extremely The group agreed that Biotrue™ represented a enthusiastic about how the three core bio-inspired real and tangible advance in the lens care field‘I am very impressed that Biotrue™ has been proven design enhancements in Biotrue™ translated into anto be effective against MRSA. This is really good that should translate into more happy patients, less excellent lens wearing experience for their patients. drop-out due to discomfort, and the opportunity tonews.’ Wim Werrelman, The Netherlands They said many patients had reported that their grow their businesses while improving patient care‘This is definitely a new-generation product. lenses felt soft, easy to apply, and they were more and satisfaction rates.It contains a really good combination of two comfortable to wear.well‑known disinfection agents.’ ‘Biotrue™ is a good product. I really appreciate itsEvelyne Le Blond, France Some patients also said they had less sensitivity efficacy results, but the comfort benefits will be most on lens application, they could wear their lenses easily understood by patients. It’s what patients want for longer, and they needed to use far fewer and what ECPs want for their patients.’ rehydration drops during the course of the day. José Manuel Gonzàlez-Méijome, Portugal Importantly, patients also reported that Biotrue™ ‘This is definitely a premium product. Given my provided a long-lasting clean, clear vision, and experience with the product, by changing patients that it kept their eyes feeling natural and healthy. to Biotrue™ even if they are not having problems, ‘My patients have told me that, for the first time ever, there is nothing to lose and potentially a lot to gain.’ they can keep their lenses in all day. They didn’t get José Manuel Gonzàlez-Méijome, Portugal dry eyes in the evening.’ ‘ECPs should consider using Biotrue™ firstly Wim Werrelman, The Netherlands because it is safe and effective and secondly, ‘Better comfort is the most obvious benefit reported because it keeps beneficial tear proteins in their**Results of in vitro study following FDA/ISO stand-alone by my patients. Patients saw the difference starting natural state.’ Øyvind Krogh, Norwayprocedure for disinfecting products. Log reduction values at a from lens application because the lens felt softer.’ ‘ECPs will be looking to the product’s efficacy asminimum soak time without organic soil. Solutions were tested Giancarlo Montani, Italy the basic reason to use an MPS. However, the factagainst several strains of S. aureus, methicillin-resistant S. aureus,and F. solani. This test is not required by FDA and ISO standards. ‘For my patients, the prolonged lubrication of the that Biotrue™ also matches the pH of healthy tears††Results of in vitro study to evaluate the ability of multi-purpose lens was the most obvious benefit. My patients and reduces protein denaturation of beneficial tearsolution disinfection efficacy against Acanthamoeba castellanii could wear their lenses for longer. This is really proteins are attractive and innovative concepts that(ATCC 30868) and Acanthamoeba polyphaga trophozoites and good.’ Øyvind Krogh, Norway should also appeal.’ Stefan Schwarz, Germanycysts. Although no FDA/ISO guidelines currently exist for testinglens care solutions against Acanthamoeba, this stand-alone test ‘Most of my patients said their lenses were more ‘This is definitely a new-generation of product. Forwas conducted following FDA/ISO procedures as a model toevaluate the inherent microbiocidal activity of a solution within the hydrated upon application, they had less burning my patients, three words sum up the product: healthy,manufacturers’ recommended disinfecting time (soak only). sensation, less end-of-day dryness, and less safe, and soft.’ Evelyne Le Blond, France
16 MagazinePractice Development Preoperative Communication About Premium Lens Implants in Cataract Patients By John A. Hovanesian, MD and Paul Karpecki, OD At present, a large majority of the eligible cataract patients in our practice elect to have a premium implant. Like a number of other practices that were early adopters of these lenses, we have clearly seen a snowball effect, where happy patients refer their friends and family to us specifically for these premium lenses. Our unusually high conversion rate has been a direct result of our constant effort to improve the way we educate our patients pre- operatively. We believe that observing the following ten “commandments” or recommendations will contribute to your success in patient conversion: Commandment 1 Believe in the technology Through experience and many, many happy patients, we have learned that we would eagerly recommend a premium implant to any close friend or family member. Every member of our staff has been extensively trained in the benefits of presbyopia correction and shares in this enthusiasm from his or her heart. Patients can easily tell the difference between a sales-pitch and a genuine, personal recommendation. If you have even 10% reservation in recommending a premium lens, it will be apparent to your patient, and you may not be ready to manage the greater expectations these patients are likely to have. To determine if you believe in the procedure consider doing some of the following: Meet with or talk to patients who have had the procedure; Observe surgery and some patient follow-up visits to witness the patients response; Go into surgery and observe the first patients you co-manage; consider having a staff member with cataracts consider the procedure to then better educate patients.