Technology Brief. Femtosecond lasers for cataract surgery

HealthPACT Health Policy Advisory Committee on Technology Australia and New Zealand Technology Brief Femtosecond lasers for cataract surgery February 2012

State of Queensland (Queensland Health) 2012 This work is licensed under a Creative Commons Attribution Non Commercial No Derivatives 2.5 Australia licence. In essence, you are free to copy and communicate the work in its current form for non commercial purposes, as long as you attribute the authors and abide by the licence terms. You may not alter or adapt the work in any way. To view a copy of this licence, visit http://creativecommons.org/licenses/by nc nd/2.5/au/. For further information, contact the HealthPACT Secretariat at: HealthPACT Secretariat c/o Access Improvement Service, Centre for Healthcare Improvement, Queensland Health Lobby 2, Level 2, Citilink Business Centre 153 Campbell Street, Bowen Hills QLD 4006 Postal Address: GPO Box 48, Brisbane Qld 4001 Email: HealthPACT@health.qld.gov.au Telephone: (07). 3131 6969 For permissions beyond the scope of this licence contact: Intellectual Property Officer, Queensland Health, GPO Box 48, Brisbane Qld 4001, email ip_officer@health.qld.gov.au, phone (07) 3234 1479. Electronic copies can be obtained from: www.health.qld.gov.au/healthpact DISCLAIMER: This brief is published with the intention of providing information of interest. It is based on information available at the time of research and cannot be expected to cover any developments arising from subsequent improvements to health technologies. This brief is based on a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered. The State of Queensland acting through Queensland Health ( Queensland Health ) does not guarantee the accuracy, currency or completeness of the information in this brief. Information may contain or summarise the views of others, and not necessarily reflect the views of Queensland Health. This brief is not intended to be used as medical advice and it is not intended to be used to diagnose, treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute for a health professional's advice. It must not be relied upon without verification from authoritative sources. Queensland Health does not accept any liability, including for any injury, loss or damage, incurred by use of or reliance on the information. This brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy Advisory Committee on Technology (HealthPACT). The production of this brief was overseen by HealthPACT. HealthPACT comprises representatives from health departments in all States and Territories, the Australian and New Zealand governments and MSAC. It is a subcommittee of the Australian Health Ministers Advisory Council (AHMAC), reporting to AHMAC s Clinical, Technical and Ethical Principal Committee (CTEPC). AHMAC supports HealthPACT through funding. This brief was prepared by Linda Mundy from the HealthPACT Secretariat

TECHNOLOGY BRIEF REGISTER ID WP059 (NOMINATION FROM SOUTH AUSTRALIA) NAME OF TECHNOLOGY FEMTOSECOND LASERS FOR CATARACT SURGERY PURPOSE AND TARGET GROUP FOR THE REMOVAL OF THE CRYSTALLINE LENS IN PATIENTS UNDERGOING CATARACT SURGERY STAGE OF DEVELOPMENT IN AUSTRALIA Yet to emerge Established Experimental Established but changed indication or modification of technique Investigational Should be taken out of use Nearly established AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION APPROVAL Yes ARTG number 181017 No Not applicable INTERNATIONAL UTILISATION COUNTRY Australia Hungary Germany Korea United States Trials underway or completed LEVEL OF USE Limited use Widely diffused IMPACT SUMMARY Although there are several ophthalmic femtosecond laser systems on the market, there is currently only one, the LenSx laser system, listed on the Australian Register of Therapeutic Goods for cataract surgery 1. The LenSx is manufactured by Alcon 1 Since writing this brief another ophthalmic femtosecond laser has been registered on the ARTG: the Designs for Vision Aust Pty Ltd - Femtosecond ophthalmic Yb: Glass laser system (ARTG number 194204) Femtosecond lasers for cataract surgery: February 2012 1

LenSx Inc (CA, United States) and is distributed by Alcon Laboratories Australia Pty Ltd. The technology would be made available through ophthalmic surgeons for patients who require cataract surgery. A brief describing the use of the IntraLase femtosecond laser for creating corneal flaps during laser in situ keratomileusis (LASIK) surgery was prepared by ASERNIP S in 2008. IntraLase was registered on the TGA (ARTG numbers 107191 and 124974), however, since that time IntraLase Corp has been taken over and these numbers are no longer current Worldwide and in Australia, cataracts are a common cause of vision loss and blindness. The only effective corrective measure is the surgical removal of the cataract. The use of the femtosecond laser, combined with an imaging and alignment system, enables the precise removal of the cataractous lens with reduced adverse events compared to conventional phacoemulsification procedure. In addition to cataract removal, the femtosecond laser may be used to perform a refractive lens exchange procedure. BACKGROUND The lens of the eye is made up primarily of protein and water and its role is to focus light onto the retina at the back of the eye (Figure 1). Cataracts are an opaque formation that develops when the protein structure of the lens breaks down and forms clumps, with the resulting cloudy appearance preventing light from passing through the lens. This opaque formation is referred to as a cataract and may occur as a result of the natural aging process, exposure to agents including x rays, infrared or ultraviolet light, systemic disease such as diabetes, some medications, traumatic injury or the use of corticosteroids (Taylor & Bilgrami 2010). Cataracts usually progress slowly resulting in a gradual loss of vision but may eventually cause blindness if left untreated. Preventative measures such as wearing UV protecting glasses may slow the progression of cataracts, however the only effective treatment is the surgical removal of the cataract, usually by phacoemulsification (see comparator section). Femtosecond lasers for cataract surgery: February 2012 2

Figure 1 Anatomy of the eye demonstrating the position of the lens, posterior and anterior chambers (printed with permission Retina Australia, Victoria) Complications of cataract surgery include endophthalmitis, retinal detachment and posterior capsular opacification 2 (PCO), which is reported to occur in approximately 20 40 per cent of patients, two to five years after cataract surgery (Merlin et al 2011; Wormstone et al 2009). Other complications that may occur include damage to the corneal endothelium due to excessive use of ultrasound energy during the phacoemulsification of hard cataracts, thermal injury to the cornea at the site of probe insertion, in addition to iris prolapse, leakage, ocular hypotension or visionthreatening intraocular infection due to poorly constructed cataract incisions (Palanker et al 2010). In a bid to reduce the number of these complications new methods of cataract removal and wound construction have been developed and are continually evolving. LASIK has been the standard procedure for performing refractive surgical procedures for the correction of myopia, hyperopia and astigmatism. During the LASIK procedure a flap of corneal tissue is mechanically cut and folded back to allow access to the inner cornea, which is then re shaped using an excimer laser (ASERNIP S 2008). Complications associated with mechanical cutting led to the development of corneal procedures that utilised femtosecond lasers, which provide greater precision. The significant reduction in the number of complications during corneal refractive surgery has resulted in the wide acceptance of femtosecond lasers for LASIK procedures. The success of the LASIK procedure has stimulated interest in the use of femtosecond lasers for cataract surgery and it is envisaged that the precision 2 PCO occurs due to residual lens epithelial cells remaining on the anterior capsule, which then go on to colonise the surface of the IOL and the posterior capsule, resulting in decreased visual acuity or a secondary cataract Femtosecond lasers for cataract surgery: February 2012 3

of these lasers will reduce the complications such as those described above (Uy et al 2011). The main steps in laser cataract surgery are: planning, engagement, visualisation and finally, treatment. To this end, the LenSx system combines the femtosecond laser with an imaging and alignment system (Figure 2). Prior to the procedure highresolution images are taken to produce accurate biometric measurements of the eye including the thickness of the lens and cornea (He et al 2011; Uy et al 2011). Several papers have reported the use of optical coherence tomography (OCT) for the 3 dimensional mapping of the eye, which is then linked to the femtosecond laser, which performs an anterior capsulotomy followed by fragmentation of the lens and corneal incisions (Palanker et al 2010). The femtosecond 3 laser delivers ultrashort pulses of energy at near infrared wavelengths capable of disrupting the targeted ocular tissue. Figure 2 The LenSx demonstrating (printed with permission Alcon Industries Inc) Patients usually undergo the cataract removal procedure during day surgery. A topical anaesthetic is applied to the eye and the eye is stabilised with a suction docking system. This sterile, single use patient interface allows visualisation of the anterior segment of the eye and locks the laser imaging system with respect to eye movement. Application of the suction patient interface results in a rise in intraocular pressure (estimated to be approximately 50mmHg), whilst maintaining a liquid interface between the eye and the laser, which will focus the laser, minimise the energy required and reduce the cavitation bubble size (He et al 2011). During the capsulotomy, which takes only 10 20 seconds, the femtosecond laser creates a 3 A femtosecond is 10-15 of a second Femtosecond lasers for cataract surgery: February 2012 4

circular incision in the anterior capsule at a pre programmed diameter. The laser is then used to create incisions within the cataractous crystalline lens (nuclear fragmentation) breaking it up to small fragments. Finally the laser creates corneal incisions to correct astigmatism and allow the surgeon to enter the anterior chamber of the eye. Patients are then transferred to a surgical suite where the fragmented lens can be manipulated, emulsified and aspirated with a phacoemulsification device following which an intraocular lens is inserted. Patients are then kept under observation for approximately one hour before being allowed home with the usual overall time in the Day Surgery being 3 4 hours (personal communication Vision Eye Institute). Click on this link for a demonstration of the cataract removal procedure using the LenSx system (Alcon Laboratories Inc 2011). In Australia there are currently 12 ophthalmic surgeons trained in the use of cataract removal using the femtosecond laser system. Training and accreditation is provided by Alcon LenSx Inc with initial training consisting of an on line web based program demonstrating the equipment, interface technology, laser safety and how to perform the surgery. After familiarisation with all aspects of the technology, the surgeon is required to undergo 10 supervised procedures under the guidance of a trained company representative (personal communication Vision Eye Institute). There are no specific infrastructure requirements for the installation of a femtosecond laser apart from standard medical facilities with the provision of an adequate room size to perform the procedure safely, with appropriate temperature and humidity control and lighting. Ideally the laser room would be situated in close proximity to the surgical suite. CLINICAL NEED AND BURDEN OF DISEASE Approximately 15 per cent of all vision loss in Australians is caused by cataract, which was also the third most common cause of blindness, accounting for 12 per cent of all cases (Taylor & Bilgrami 2010). Australian prevalence data for cataract are based on two large population based studies conducted in the 1990s: the Melbourne Visual Impairment Project (MVIP) and the Blue Mountains Eye Study (BMES). Combined prevalence data from these two studies estimated rates of vision loss and blindness from cataract that steadily increased with age (Table 1) (Taylor & Bilgrami 2010). Femtosecond lasers for cataract surgery: February 2012 5

Table 1 Prevalence rates fro vision loss and blindness from cataract (Taylor & Bilgrami 2010) Age group Vision loss (including blindness) Blindness 40-49 - - 50-59 0.04% - 60-69 0.09% - 70-79 1.42% 0.05% 80-89 6.63% 0.75% 90+ 15.17% 15.51% When these rates are applied to the population in 2009, it is estimated that approximately 84,960 people may have experienced vision loss from cataract in that year, with 7,700 of these individuals blind due to cataract. Projected rates of vision loss and blindness based on the MVIP and BMES studies and projected population numbers are summarised in Table 2 (Taylor & Bilgrami 2010). Table 2 Projected number of individuals with vision loss and blindness from cataract (Taylor & Bilgrami 2010) Age group 2011 2014 2017 2020 VL Blind VL Blind VL Blind VL Blind 40-49 - - - - 50-59 1,225-1,291-1,332-1,354-60-69 1,874-2,056-2,179-2,294-70-79 18,355 685 20,405 761 23,541 878 26,824 1,001 80-89 48,074 5,448 50,152 5,683 53,138 6,022 57,531 6,520 90+ 22,446 2,240 27,998 2,794 33,447 3,338 38,371 3,829 Total 91,974 8,373 101,902 9,238 113,629 10,238 126,373 11,349 VL = vision loss, including blindness, Blind = blindness There are a number of Medicare Benefits Schedule item numbers that cover the removal of cataracts: 42698 LENS EXTRACTION, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres following the removal of cataract in the first eye; 42701 ARTIFICIAL LENS, insertion of, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres following the removal of cataract in the first eye; 42702 LENS EXTRACTION AND INSERTION OF ARTIFICIAL LENS, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres following the removal of cataract in the first eye; Femtosecond lasers for cataract surgery: February 2012 6

42707 ARTIFICIAL LENS, REMOVAL of and REPLACEMENT with a different lens, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres following the removal of cataract in the first eye; and 42716 CATARACT, JUVENILE, removal of, including subsequent needlings. The total number of services provided for these MBS item numbers is summarised in Table 3, indicating the number of cataract procedures performed in the private sector. Table 3 Number of cataract services performed, July 2010 June 2011 MBS item number Number of services 42698 224 42701 438 42702 135,815 42707 397 42716 78 Total 136,952 The AIHW hospital morbidity database reported that the total number of procedures performed in Australia s public hospitals on the anterior segment of the lens for the year 2005 2006 was 179,118. The most common procedure associated with the lens of the eye was 197: Extracapsular crystalline lens extraction by phacoemulsification, with 165,848 procedures performed, and of these, 155,070 were performed on the same day as admittance. DIFFUSION OF TECHNOLOGY IN AUSTRALIA An Alcon LenSx system was installed in the Vision Eye Institute in Sydney in April 2011, which was the fourth such system installed worldwide (Budapest, Hungary; Texas and Utah, USA). Since installation, this facility has performed in excess of 1,000 laser cataract procedures for private patients. Since this time, two additional units have been installed in private clinics: one in Sydney, one in Melbourne and one will be installed in Hobart early in 2012. Worldwide there are approximately 170 ophthalmic surgeons trained in the cataract removal procedure using LenSx laser and the total number of procedures performed is in the region of 7,500 (personal communication Vision Eye Institute). COMPARATORS Cataract surgery is a common procedure with phacoemulsification being the preferred method. During this procedure an incision is made in the eye to enable the removal of the anterior face of the capsule containing the crystalline lens. A probe is Femtosecond lasers for cataract surgery: February 2012 7

introduced into the eye and the cataract is broken up, usually by ultrasound, into small pieces which are then emulsified and removed by aspiration. The entire posterior capsule and the remaining portion of the anterior capsule are left behind forming a capsular bag. The lens is replaced with an in situ permanent intra ocular lens implant (IOL), which is positioned in the capsular bag and allows the eye to focus again. By leaving the posterior lens capsule intact an anatomical barrier between the anterior and posterior segments of the eye is formed, reducing the number of potential complications compared to procedures in which the whole lens with intact capsule is removed from the eye (Merlin et al 2011). SAFETY AND EFFECTIVENESS Nagy et al (2009) reported the preliminary results of anterior capsulotomy and phacofragmentation performed with a femtoseond laser (LenSx ) in porcine eyes. Following the success of these procedures, a small case series (n=9) was conducted in human patients (mean age 61 years, range 48 to 77 years) (level IV intervention evidence). The first patients in the series underwent only one aspect of the cataract removal procedure, that is, three patients underwent lens fragmentation and three patients underwent anterior capsulotomy only. The final three patients underwent both anterior capsulotomy and lens fragmentation using the LenSx laser system. After planning and patient preparation, the combined laser capsulotomy and fragmentation procedure was performed in less than one minute. Following the laser procedure, patients were evaluated with optical coherence tomography (OCT), which revealed a complete cut edge in all scanned meridians. The procedure was completed with standard phacoemulsification. Patients were followed up postoperatively at the standard time points following cataract surgery at one day, one week and one month. Anterior capsulotomy was complete in all patients that underwent this procedure, with no additional incisions required and no radial tears reported. In addition, the size of the removed capsule equalled the measurements taken during procedure planning. Lens removal and IOL implantation was uneventful in all eyes, with no posterior capsule tears reported. At day one follow up, mild oedema and trace anterior chamber cells were observed in 7/9 (78%) and 6/9 (67%) patients, respectively, however these symptoms were resolved at 1 week follow up. At day 1, corrected distance visual acuity was 20/40 4 or better in 7/9 (78%) eyes. At 1 week follow up all nine patients had achieved 20/40 visual acuity, which improved in all patients to 20/20 at 1 month follow up. Mean baseline intraocular pressure 5 (IOP) 4 A visual acuity of 20/20 is frequently described as meaning that a person can see detail from 20 feet away the same as a person with normal eyesight would see from 20 feet. If a person has a visual acuity of 20/40, they can see detail from 20 feet away the same as a person with normal eyesight would see it from 40 feet. 5 Normal IOP is considered to be between 20 to 21 mmhg. Femtosecond lasers for cataract surgery: February 2012 8

was 13.8 mmhg (range 10 18 mmhg). Mean IOP at 1 day, 1 week and 1 month follow up was 16.1 (range 12 to 19), 16.0 (15 to 18) and 14.2 (11 to 18) mmhg, respectively (Nagy et al 2009). An abstract submitted to the Association for Research in Vision and Ophthalmology s 2010 conference compared the clinical outcomes of patients who underwent conventional phacoemulsification in one eye and femtosecond laser cataract surgery in the other eye (level III 2 intervention evidence). Laser capsulotomy with or without lens fragmentation was performed first on the eye that was the most visually compromised. As a control, the fellow eye was subsequently operated on using standard phacoemulsification surgery. The time between these two procedures being performed was not stated (Edwards et al 2010). Only the results from 60 laser treated eyes and 45 conventionally treated fellow eyes were reported. It is unclear what the clinical outcomes of the remaining 15 control eyes were. At 3 month follow up logmar uncorrected visual acuity was 0.30 ± 0.20 and 0.23 ± 0.16 for the laser and control eyes, respectively. The logmar 6 best corrected visual acuity 7 was 0.05 ± 0.10 and 0.03 ± 0.05 for laser and control eyes, respectively. Although the differences between visual acuity in the intervention (laser) eyes and the control eyes were small it is unclear whether these differences were clinically significant or not as a statistical analysis was not reported. IOP was 14 ± 2 mmhg for both groups at baseline and was 13±2mmHg at 3 months. Three and four eyes in the laser and control group, respectively, reported pressures over 25mmHg at day one post operatively, however this increase in pressure had reduced by 1 week follow up. A rise in IOP of >10 mmhg at day 1 was noted in four eyes in each group, which was also resolved by 1 week. At 3 months corneal thickness was 548 ± 38um and 542 ± 57um at baseline and 531 ± 37um and 529 ± 45um for laser and control groups, respectively (Edwards et al 2010). One of safety issues associated with cataract surgery is the occurrence of subclinical macular oedema and an associated increase in retinal thickness. To assess whether or not the suction ring used during the positioning of the femtosecond laser had any effect on macular structure, the small study by Ecsedy et al (2011) measured macular thickness using OCT in continuous curvilinear capsulorrhexis (CCC, n=20) and femtosecond laser (FS, n=20) treated eyes (in different patients not fellow eyes). There was no statistical difference in post operative macular thickness between the two groups 8, however differences were noted between the two groups after adjusting for age and pre operative thickness. The inner macular ring in the CCC 6 logmar 0.00 = 20/20, logmar 0.30 = 20/40, logmar 0.20 = 20/32 7 Best corrected visual acuity means the best visual acuity score that can be achieved when the best glasses prescription is used. 8 At baseline, there was no difference between the control and laser groups in the mean macular thickness Femtosecond lasers for cataract surgery: February 2012 9

group was significantly thicker at 1 week follow up (mean difference 21.68 µm, 95% CI [11.93, 31.44], p<0.001). This difference was reduced at 1 month follow up to a mean difference of 17.56 µm (p=0.09). Macular thickness increased significantly compared to baseline (273.3 µm) in the CCC group at 1 week (287.76 µm, p<0.001) and continued to increase at 1 month (298.38 µm, p=0.003). In comparison, macular thickness in the FS group did not increase at 1 week but was significantly increased at 1 month (281.98 µm, p=0.02). This delay in macular thickness may be due to inflammation caused by the manipulation of the intraocular tissues. Although this small study suggests that FS laser removal of cataracts is associated with reduced early macular thickness compared to CCC, a longer follow up period would be required for any firm conclusions. The visual acuity results of this study are summarised in Table 4 (Ecsedy et al 2011) (level III 2 intervention evidence). Table 4 Visual acuity results (Ecsedy et al 2011) FS group (n=20) Median corrected distance visual acuity Pre-op 0.32 ± 0.24 log MAR 1-week 0.16 ± 0.27 log MAR 1-month 0.08 ± 0.19 log MAR CCC control group (n=20) Median corrected distance visual acuity Pre-op 0.39 ± 0.28 log MAR 1-week 0.08 ± 0.16 log MAR 1-month 0.02 ± 0.06 log MAR Several papers describing technical aspects of FS cataract removal compared to CCC have been published by the same collaborating researchers, with at least two of these authors acknowledging a financial arrangement with Alcon LenSx Lasers Inc. The results of these studies were not summarised in this brief due to their technical nature, rather than an emphasis on safety and effectiveness (Kranitz et al 2011; Mihaltz et al 2011; Nagy et al 2011). These studies concluded that the removal of cataract by FS was more precise and that the FS procedure resulted in a superior positioning of the IOL. COST IMPACT The Alcon LenSx costs approximately A$600,000 (personal communication Alcon Laboratories Australia Pty Ltd). There are several Medicare Benefits Schedule item numbers associated with the removal of cataracts and the insertion of an IOL (42698, 42701, 42702, 42707 and 42716 with respective fees of: $583.65, $325.50, $746.45, $782.25 and $1,173.40) with each one applicable for either manual or laser cataract surgery. There is no specific MBS item number for femtosecond laser anterior capsulotomy. The cost of a cataract removal procedure, in one eye, using the femtosecond procedure is estimated to be a total of $2,000 to $3,350, which is broken down to $1,150 to $2,500 for the surgery and $850 for the laser component. Currently the $850 cost for Femtosecond lasers for cataract surgery: February 2012 10

the laser is a private co payment with no additional cost to the public health system or Medicare. The 2009 allocated health system expenditure for conditions of the eye was $2.58 billion. It has been estimated that of this total, cataracts accounted for 18 per cent of this expenditure, and as such is the largest single disease cost care category ahead of refractive error (16%) and glaucoma (8%). Access Economics have projected that the total allocated health systems costs for cataract will increase from $459 million in 2009 to $847 million in 2020 (Taylor & Bilgrami 2010). ETHICAL, CULTURAL OR RELIGIOUS CONSIDERATIONS Approximately 80 per cent of Aboriginal and Torres Strait Islander adults report having eye problems. Among those aged over 40 years, Aboriginal and Torres Strait Islander people have six times the rate of blindness of non Indigenous Australians, with the most common cause of blindness being cataract, making up 32 per cent of cases (AIHW 2012). OTHER ISSUES This technology is likely to only be available in major regional centres in private practice. In Australia, the majority of eye health workers work in city centres (80%), however in 2006, less than 67 per cent of the Australian population with eye disorders live in city centres (AIHW 2009). The results of the first 1,000 cases of cataract surgery conducted by the Vision Eye Institute in Sydney using the Alcon LenSx system is to be reported early in 2012 in Ophthalmology. SUMMARY OF FINDINGS The studies included for assessment in this brief described the results of early, explorative studies on small patient groups. These early studies have indicated that the use of femtosecond lasers to remove cataract is effective with what appears to be very little difference in clinical outcomes when compared to conventional anterior capsulotomy (visual acuity, macular thickness and adverse events). However, there was little statistical analysis of the results, possibly due to the small sample size. Therefore firm conclusions as to the effectiveness of the FS procedure compared to CCC are difficult to make. A large Australian study (1,000 patients) is due to be published in January 2012, however it is a case series and therefore not comparative and capable of informing safety aspects of the FS procedure. Although it would be prudent to await the publication of any randomised controlled trials evaluating the Femtosecond lasers for cataract surgery: February 2012 11

use of FS compared to CCC, it would appear that this technology is rapidly diffusing throughout the private health sector in Australia. HEALTHPACT ASSESSMENT: There appears to be no significant clinical advantage over the use of the femtosecond lasers to remove cataracts in comparison to conventional phacoemulsification, especially when consideration is given to the high cost of the new technology. It would appear that the femtosecond laser technology for the removal of cataracts is rapidly diffusing in the private sector throughout Australia, however the technology is unlikely to impact on the public system in terms of patient flow and reduced waiting times for cataract surgery. There is a paucity of comparative evidence, in the form of randomised controlled trials, with the reported evidence to date conducted on relatively small patient groups. Therefore HealthPACT have recommended that this technology be monitored for further information in 24 months. NUMBER OF STUDIES INCLUDED All evidence included for assessment in this Technology Brief has been assessed according to the revised NHMRC levels of evidence. A document summarising these levels may be accessed via the following link on the HealthPACT web site. Total number of studies 3 Total number of level III 2 intervention evidence 2 Total number of level IV intervention evidence 1 REFERENCES AIHW (2012). Eye health in Aboriginal and Torres Strait Islander people [Internet]. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/access/201108/feature/eye health.cfm [Accessed 16th January]. AIHW (2009). Eye health labour force in Australia, Australian Institute of Health and Welfare, Canberra, Available from: http://www.aihw.gov.au/publicationdetail/?id=6442468281&tab=2. Alcon Laboratories Inc (2011). LenSx [Internet]. Available from: http://www.lensxlasers.com [Accessed 23rd December 2011]. ASERNIP S (2008). The IntraLase femtosecond laser update, Australian Safety and Efficacy Register of New Interventional Procedures Surgical, Available from: http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/content/e76b DEECDE7BD1A8CA2575AD0080F341/$File/The%20IntraLase%C2%AE%20femtosecon d%20laser%20(update).pdf. Ecsedy, M., Mihaltz, K. et al (2011). 'Effect of femtosecond laser cataract surgery on the macula', J Refract Surg, 27 (10), 717 722. Femtosecond lasers for cataract surgery: February 2012 12

Edwards, K. H., Frey, R. W. et al (2010). 'Clinical Outcomes Following Laser Cataract Surgery', Invest. Ophthalmol. Vis. Sci., 51 (5), 5394. He, L., Sheehy, K. & Culbertson, W. (2011). 'Femtosecond laser assisted cataract surgery', Curr Opin Ophthalmol, 22 (1), 43 52. Kranitz, K., Takacs, A. et al (2011). 'Femtosecond laser capsulotomy and manual continuous curvilinear capsulorrhexis parameters and their effects on intraocular lens centration', J Refract Surg, 27 (8), 558 563. Merlin, T., Street, J. et al (2011). Review of MBS Items for specific ophthalmology services under the MBS Quality Framework, Medicare Benefits Division, Department of Health and Ageing, the Australian Government, Canberra, ACT, Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/content/65a4239557e05a9 8CA2579260078E8ED/$File/MBS%20Ophthalm%20Services%20review_final%20repo rt_public%20consult%20v6.pdf. Mihaltz, K., Knorz, M. C. et al (2011). 'Internal aberrations and optical quality after femtosecond laser anterior capsulotomy in cataract surgery', J Refract Surg, 27 (10), 711 716. Nagy, Z., Takacs, A. et al (2009). 'Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery', J Refract Surg, 25 (12), 1053 1060. Nagy, Z. Z., Kranitz, K. et al (2011). 'Comparison of intraocular lens decentration parameters after femtosecond and manual capsulotomies', J Refract Surg, 27 (8), 564 569. Palanker, D. V., Blumenkranz, M. S. et al (2010). 'Femtosecond laser assisted cataract surgery with integrated optical coherence tomography', Sci Transl Med, 2 (58), 58ra85. Taylor, P. & Bilgrami, A. (2010). Clear Focus The Economic Impact of Vision Loss in Australia in 2009, Vision 2020 Australia and Access Economics Pty Limited, Melbourne, Available from: http://www.vision2020australia.org.au/assets/content/3647/v2020aus_report_clear _focus_jun10w.pdf. Uy, H. S., Edwards, K. & Curtis, N. (2012). 'Femtosecond phacoemulsification: the business and the medicine', Curr Opin Ophthalmol, 23(1):33 9. Wormstone, I. M., Wang, L. & Liu, C. S. (2009). 'Posterior capsule opacification', Exp Eye Res, 88 (2), 257 269. SEARCH CRITERIA TO BE USED Cataract extraction Cornea/pathology Cornea/surgery Lasers, excimer/therapeutic use Laser therapy Capsulorhexis/methods Lens capsule, crystalline/surgery Anterior capsule of the lens/pathology Anterior capsule of the lens/surgery Femtosecond lasers for cataract surgery: February 2012 13