Optometry in Practice 2014 Volume 15 Issue 2 49 – 56 Laser-assisted cataract surgery: an overview Andreas Hartwig Dipl-Ing(FH) PhD FAAO, Sundeep Kheterpal MA FRCS MRCOphth, Jay Dermott DOpt BSc FFDO and Clare O’Donnell PhD MBA MCOptom FAAO FBCLA Optegra Eye Sciences, Manchester EV-20108 C-36666 1 CET point for UK optometrists Introduction Cataract surgery Cataract is the most common cause of treatable blindness and estimates suggest that cataract accounted for around 20 million cases of blindness worldwide in 2010 (World Heath Organization 2010). As age expectancy increases, the number of people with cataract is expected to grow. Cataract surgery is the most commonly performed surgical procedure, with over 330 000 cases performed each year in England alone (Royal College of Ophthalmologists 2010). Although cataract surgery is considered to be very successful, no surgery is completely without risk and complications such as corneal oedema, raised intraocular pressure, cystoid macular oedema, endophthalmitis, posterior capsular opacification and refractive surprise can still occur (Barry et al. 2013; Jaycock et al. 2009; Lundström et al. 2013). Therefore, the desire to strive for further refinements and improvements continues. Cataract surgery typically involves pupillary dilation, application of a local anaesthetic and creation of a corneal incision or incisions to access the ocular structures. A viscoelastic substance called an ophthalmic viscosurgical device or OVD is used to stabilise the anterior chamber and to help protect the integrity of the structures, including the corneal endothelium. Femtosecond lasers have a unique ability to create small and discreet disruptions to tissue with minimal adverse effects to surrounding tissues. In brief, the process involves the absorption of femtosecond laser energy by the target tissue, which creates a cloud of free electrons and ionised molecules which expands and collapses rapidly. This leads to the production of small cavitation bubbles and an acoustic shock wave that cuts and separates the tissue (Donaldson et al. 2013; Soong and Malta 2009; Sugar 2002). This photodisruption approach enables precise cutting in the cornea, lens capsule and crystalline lens. The technology has been used successfully in corneal laser vision correction for many years (Salomao and Wilson 2010) and it is now being applied to cataract surgery. The first laser-assisted refractive cataract surgery in humans was performed in Hungary in 2008 and the technology is now available in other countries, including the UK. It is envisaged that femtosecond laser-assisted cataract surgery (FLACS) may lead to further improvements in surgical, visual and refractive outcomes. This paper aims to provide an overview of FLACS, written for the practising optometrist, who, as the trusted primary eye care provider, is in an excellent position to advise patients who may enquire about this new technology. A circular opening in the anterior capsule (capsulorhexis) is made by freehand tearing using forceps. Creating a well-centred and perfectly circular capsulorhexis requires a high level of skill and this can be especially challenging in cases of shallow anterior chambers, mature cataract or weak zonules. Any radial tears in the anterior capsule can extend posteriorly, leading to possible luxation of the nucleus into the vitreous cavity, further complications and poorer clinical outcomes (Lundström et al. 2013). If the capsulorhexis is too small, the nucleus may be difficult to remove, the capsule may fibrose and hyperopic shift may result (Sciscio and Liu 1999). If there is variation in the extent of contact or areas where there is insufficient contact between the capsule circumference and the optic of the intraocular lens (IOL), decentration, rotation or posterior capsular opacification can occur (Kranitz et al. 2012; Trikha et al. 2013). This can therefore influence the refractive and visual outcomes (Kranitz et al. 2012), particularly with advanced technology implants such as toric, accommodating or multifocal IOLs (Trikha et al. 2013). After creating the capsulorhexis, fluid is used to separate the lens cortex from the capsule, allowing the lens to be rotated within the capsular bag. An instrument to hold and turn the lens and another that uses ultrasonic vibration to fragment and aspirate the lens are then used. The nucleus is removed by sculpting, chopping and emulsification. The phacoemulsification power, pulse, aspiration rate and vacuum parameters can be adjusted, depending on the cataract being treated. Excessive manipulation can increase the risk of injury to the cornea, iris or capsule (Trikha et al. 2013) and excessive ultrasound power can also be damaging (Murano et al. 2008). After the lens fragments have been removed, an IOL is implanted, typically into the capsular bag. The OVD is removed and the incision is left sutureless. Date of acceptance: 19 May 2014. Address for correspondence: C O’Donnell, Optegra Eye Sciences, One Didsbury Point, 2 The Avenue, Didsbury, Manchester M20 2EY, UK. [email protected] © 2014 The College of Optometrists 49 A Hartwig et al. Femtosecond laser-assisted cataract surgery Femtosecond laser technology has various applications during cataract surgery. The laser can be used to make the corneal incisions, create the anterior capsulotomy and to liquefy or fragment the crystalline lens (Sutton et al. 2013; Trikha et al. 2013). The pupil is dilated and a topical anaesthetic is administered with or without mild sedation. There are four different systems available, but the approach used is broadly similar across these platforms (Figure 1). Figure 2. Docking stage. After imaging (Figure 3) and registration, the laser aspect of the treatment can begin, followed by lens removal using phacoemulsification and finally IOL implantation. The laser part of the procedure may be carried out in a different room from the rest of the surgery and the patient may have to be moved in some settings. The reasons for this are that some systems are too large for some operating theatres and it may be that one laser may be used by more than one operating theatre. Figure 1. Laser-assisted cataract surgery system. Planning the surgery includes assessing the anatomy of the patient’s eye, including pupil diameter, anterior-chamber depth and the thickness of the cornea and lens. The capsulotomy size, shape and centration are planned, taking into account the IOL being implanted. The lens fragmentation pattern is chosen and this will influence the amount of phaco time and power required later in the procedure. The placement, depth, length and axis of the corneal incisions are determined. The patient’s eye is stabilised by ‘docking’ the eye into the laser platform using either a curved contact lens or liquid interface-type coupling system (Figure 2). Suction pressure can result in subconjuctival haemorrhage and redness (Chang et al. 2014; Nagy et al. 2014; Uy et al. 2012). Some of the docking systems have the potential to induce distortion or compression of the cornea which can affect image quality. Advanced cataracts can make imaging of the posterior capsule more challenging with some systems. A temporary increase in intraocular pressure usually occurs (Schultz et al. 2013). When the eye is properly docked, high-resolution imaging of the ocular structures (including the cornea, iris, lens and posterior capsule) is possible. 50 Figure 3. Imaging stage. The FLACS systems currently available include Lens Sx (Alcon, Alisa Viejo, CA, USA), LensAR (LensAR, Orlando, FL, USA) (Figure 1), VICTUS (Bausch & Lomb, Technolas Perfect Vision Rochester, NY, USA) and Catalys (Optimedica, Santa Clara, CA, USA). All systems include an anterior-segment imaging system, patient interface and femtosecond laser. Differences between systems include the imaging and docking technology used and different treatment algorithms. Systems differ in the Laser-assisted cataract surgery: an overview patterns of cuts and the order in which the various steps in the procedure are delivered. The imaging systems incorporated are based on optical coherence tomography or Scheimpflug-based imaging technology. Donaldson et al. (2013) point out there is inconsistency in the nomenclature and acronyms used for the FLACS procedure, with alternatives including ReLACS (refractive laser-assisted cataract surgery), FALCS (femtosecond-assisted laser cataract surgery) and T-LACS (therapeutic laser-assisted cataract surgery). In brief, the femtosecond laser has the following applications during cataract surgery. Corneal incisions The size, location and architecture of a corneal incision will determine its effect on the postoperative cylindrical refractive component (Klamann et al. 2013). Extracapsular cataract incisions and suturing historically encompassed up to 180° of the cornea, inducing large amounts of astigmatism. This was reduced by removing sutures and some reduction naturally occurred over time due to the healing process. The small (<3mm) incisions used nowadays induce cylinders typically <0.5DC (Ernest et al. 2011; Gross and Miller 1996; Samuelson et al. 1991). During IOL surgery the main corneal incision may be placed temporally along the steepest corneal meridian to minimise postoperative astigmatism. Self-sealing corneal incisions are the method of choice for gaining access to the anterior chamber (Leaming 2003). These incisions can be created by a femtosecond laser. The parameters of the incision can be important determinants for the outcome of surgery and the femtosecond laser has the potential to provide more precise incisions than those created manually (Masket et al. 2010; Palanker et al. 2010). It has been suggested that better-constructed wounds achieved with a laser may result in faster healing times, less tissue damage and less wound leakage and they could even reduce the risk of endophthalmitis (Ernest et al. 1991; Masket et al. 2010; Trikha et al. 2013). At present, the laser-created incisions are designed to be initially incomplete, ready to be opened with a blunt instrument, so the anterior chamber is not breached during surgery as needed. Clear corneal or limbal relaxing incisions (LRIs) can be used to reduce corneal astigmatism. This involves making incisions which straddle the steepest corneal meridian. The parameters and location of the incisions can be adjusted to produce the desired change in corneal power using formulae called nomograms. The changes are essentially achieved by flattening the steep meridian. Two clear corneal incisions are paired opposite each other in the steep meridian for astigmatism reduction and another incision is placed for surgical access to the anterior chamber (Amesbury and Miller 2009). With manual or laser LRIs the risk of corneal perforation is reduced and there is less likelihood of irregular astigmatism being induced since the surgery is performed further from the visual axis. Furthermore, they cause minimal foreign-body sensation and glare and allow faster visual recovery than clear corneal incisions (Kleiman et al. 2007). Manual creation of LRIs of the correct width and depth can be challenging in terms of precision and safety (Bartels et al. 2006). Laser-assisted LRIs may improve the predictability compared to manual LRIs for correction of lower degrees of astigmatism (Buzzonetti et al. 2009), although for higher degrees of astigmatism, toric IOLs may be preferred for patients undergoing IOL surgery. Anterior capsulotomy Creation of an accurate anterior capsulotomy during IOL surgery is important, since its circularity and size influence the performance of the implanted IOL (Cekic and Batman 1999, Friedman et al. 2011; Norrby 2008; Ravalico et al. 1996; Sanders et al. 2006; Walkow et al. 1998). FLACS systems enable the capsulotomy to be centred over the pupil centre or over the optical axis of the crystalline lens. The optimal capsule diameter will be determined by factors including the optic diameter of the implant and a well-executed capsulotomy will influence IOL stability, effective lens position and refractive predictability and will help reduce the likelihood of posterior-capsule opacification (Trikha et al. 2103). The femtosecond laser-created capsulotomy has been shown to be more accurate in terms of its shape, centration and diameter (Friedman et al. 2011; Nagy et al. 2009; Prasad Reddy et al. 2013; Tackman et al. 2011). Mayer et al. (2014) suggested that the precision and morphology of FLACS capsulotomies may reduce the rate of posterior capsule opacification. The centration of the IOL has also been shown to be more accurate (Batlle 2010; Kranitz et al. 2011; Nagy 2010) and refractive outcomes have been shown to be closer to the target postoperative refraction (Edwards et al. 2010, 2012; Filkorn et al. 2012) in some FLACS studies. These data lend support to the assertion that laser capsulotomy has a positive influence on the consistency of effective lens position. The differences between manual and laser-guided capsulotomy might be even more important where more advanced lens designs such as accommodating, multifocal or toric IOLs are being used (Uy et al. 2011). Kranitz et al. (2011) and Nagy et al. (2011) demonstrated decreased rates of incomplete overlap of the capsule edge and less horizontal decentration of the IOL with laser capsulotomy. To create a precise opening in the anterior capsule with a laser, it is essential that the crystalline lens is correctly aligned during the procedure. Any tilt of the lens relative to the axis of the laser would lead to errors in applying the laser where intended (Bali et al. 2012). To overcome this, FLACS systems can adjust the laser axis accordingly. It has been shown that IOL tilt and decentration are reduced when the capsulotomy is created using a femtosecond laser in comparison to manual capsulorhexis (Kranitz et al. 2012). It has been suggested there may be rare instances where it is deemed advantageous to tilt or decentre an implanted IOL deliberately, for example, in cases of vertical strabismus (Nishimoto et al. 2007), and this can be accommodated with FLACS. Capsule strength studies have shown that capsulotomies created with a laser are stronger, needing more force to stretch 51 A Hartwig et al. compared to manually created capsulorhexes (Auffarth et al. 2013; Frey et al. 2009; Friedman et al. 2011; Nagy et al. 2009; Palanker et al. 2010). Even though there appear to be clear benefits of femtosecond laser surgery, there are also some potential risks. Abell et al. (2014) showed that an increase in capsule tears can occur and noted irregular ‘postage stamp’ perforations at the capsule margin in some FLACS capsulotomies, as seen by scanning electron microscopy (SEM). Using light and SEM, Ostovic et al. (2013) showed that, although laser-assisted capsulotomy specimens appeared rounder, more tags, bridges, rougher edges and demarcation lines at the capsulotomy edge were seen compared to the manual capsulorhexes. They suggested this may be due to minimal torsional eye movements during laser surgery and these effects may be reduced by using a liquid immersion/soft patient interface and lowering the pulse energy used. In their SEM study, Mastropasqua et al. (2013) reported that FLACS capsulotomy resulted in better geometry and circularity and more homogeneous edge thickness. Smoother cut surfaces were seen in the manual group, with the degree of irregularity influenced by increasing energy settings in the femtosecond laser group. The authors suggested that future studies should aim to identify the optimum settings to use in femtosecond laser surgery. FLACS has been associated with a higher risk of capsular block syndrome, where gas is thought to accumulate within the lens, causing it to expand in volume. The edge of the laser capsulotomy forms a seal around the expanded nucleus, restricting fluid flow and resulting in pressure on the capsule, posterior capsular rupture and lens dislocation (Roberts et al. 2011). Awareness and modification of technique help to avoid this. Lens liquefaction and fragmentation The femtosecond laser can be used for softening and fragmenting the lens (Donaldson et al. 2013; He et al. 2011; Nagy 2012). The FLACS treatment algorithms are optimised for different grades of cataract. The technology enables lower ultrasound energy levels to be applied for additional safety to the corneal endothelium (Acar et al. 2011; Murano et al. 2008; Prasad Reddy et al. 2013) and faster visual recovery (Edwards et al. 2010; He et al. 2011; Takacs et al. 2012). Nagy et al. (2009) reported that the use of the femtosecond laser resulted in a 43% reduction in phacoemulsification power and a 51% reduction in phacoemulsification time. The time spent on phacoemulsification after pretreatment with a femtosecond laser is significantly shorter than performing phacoemulsification alone (Abell et al. 2013a, b; Conrad-Hengerer et al. 2012a). Abell et al. (2013c) suggested that anterior-segment inflammation may be less after FLACS than after manual surgery and suggested this may be due to reduced phacoemulsification energy. Attempts to demonstrate whether some fragmentation patterns (Figure 4) are superior to others in terms of reducing phacoemulsification time are under way (Conrad-Hengerer et al. 2012b; Donaldson et al. 2013). Trikha et al. (2013) suggest that an ultimate aim may be to develop algorithms that avoid the need for any ultrasound energy at all. Kelkar 52 et al. (2008) suggested that, whenever more instruments are introduced into the eye during surgery, there is a potential increase in the risk of endophthalmitis. Whether using a laser could reduce the number of instruments required during surgery and therefore could potentially further reduce the risk of infection remains to be seen. Figure 4. Fragmentation pattern. Experience with FLACS Emerging data from published studies that have evaluated FLACS in humans provide evidence that the technique can provide good visual outcomes and reduced complications and there appear to be no significant safety concerns. As stated above, correct docking is important and misalignment or slipping of the eye during the treatment can mean suction is lost. The creation of corneal incisions and capsulorhexis takes only a few seconds, so suction loss during this part of the procedure is rare (Donaldson et al. 2013). When comparing a curved contact lens interface with a liquid optical immersion interface, it was shown that the curved contact lens interface can lead to corneal folds which can adversely affect the capsulotomy. Using a liquid interface, corneal folds were not observed and the stability of the eye during the procedure was enhanced. Fewer subconjunctival haemorrhages and reduced IOP increase were also observed (Donaldson et al. 2013; Talamo et al. 2013). Contraindications It is necessary to bear in mind that cataract surgery using a femtosecond laser needs dilation of the pupil and poor dilation and posterior synechiae are relative contraindications. Other relative contraindications include corneal opacities (which may affect absorption of the laser) or conditions leading to instability of the lens. Although the level of increase in IOP has been shown to be modest compared to that seen in other laser procedures (Kerr et al. 2013), the FLACS approach may not be appropriate in cases of advanced Laser-assisted cataract surgery: an overview glaucoma or visual field loss. Poor mobility, tremor, nystagmus, attention deficit disorders, inability to lie flat, deep-set eyes and narrow palpebral apertures are additional relative contraindications to FLACS (Donaldson et al. 2013; Trikha et al. 2013). Trikha et al. (2013) suggest there are limitations regarding the grade and nature of the cataract that can be treated. They suggest lens fragmentation is only possible to Lens Opacities Classification System (LOCS) grade 4.0 and that posterior subcapsular cataracts may also require an alternative approach. It is essential that the patient’s head can be correctly positioned for docking. Retina Another important factor may be the influence of the laser on the retina. Palanker et al. (2010) showed that there was no evidence of retinal damage caused by the laser in rabbit eyes. In addition it was found that the thickening of the inner macular ring and macular oedema were significantly less when the femtosecond laser was used for lens fragmentation, perhaps due to reduced phacoemulsification energy, as described above (Ecsedy et al. 2011; Nagy et al. 2012). Conclusion In conclusion, FLACS potentially provides several advantages over standard cataract surgery. It is expected that, as surgeons and patients become more familiar with this approach, laser-assisted surgery may become an established component of cataract surgery in future. It is likely that there will be refinements to IOLs, with new models being designed especially for this purpose. Hundreds of thousands of femtosecond laser-assisted cataract surgical procedures have already been performed worldwide. Although the potential for better outcomes and safety profiles is clearly promising, the technology is costly and detractors point out that there is no definitive evidence yet proving its superiority over conventional small-incision phacoemulsification surgery. However, FLACS is still in its infancy and it has been proposed that widespread acceptance will be influenced by the emerging scientific evidence and socioeconomic factors in the coming years (Trikha et al. 2013). In the meantime the practising optometrist is in an excellent position to advise and educate patients about this exciting new technology. ‘Learning curve’ There is a ‘learning curve’ associated with the procedure and, in a report on early experience with FLACS, the average time spent in the theatre was slightly longer when applying the femtosecond laser compared to conventional surgery (Bali et al. 2012). It is expected that the procedure time will reduce as the clinical teams become more familiar with the technology and workflow. It was shown that with experience the number of docking attempts required tends to decrease (Nagy et al. 2014; Roberts et al. 2013) and similarly there was a trend towards fewer complications (Bali et al. 2012; Nagy et al. 2014; Roberts et al. 2013). It has been suggested that FLACS may allow less experienced surgeons to obtain better results, but it may fail to demonstrate significant improvements for experienced surgeons not implanting advanced-technology IOLs (Trikha et al. 2013). With time it may be that FLACS becomes the preferred method for dealing with more complex cataract cases (Conrad-Hengerer et al. 2013; Trikha et al. 2013). Despite the potential benefits, there is a high cost in implementing this technology and the use of FLACS is not yet widespread. With time, increasing awareness and evidence from longer-term prospective randomised controlled trials, this may change and FLACS may well become the standard of care in future. Other applications Femtosecond lasers have been shown to bleach the crystalline lens, decreasing the amount of age-induced yellow discoloration, and it has been suggested that they could be used to postpone the need for cataract surgery by several years (Kessel et al. 2010). Another possible application is using the femtosecond laser to provide some restoration of accommodation ability to presbyopic patients by creating sliding planes within the lens and trials are currently under way (Krueger et al. 2005). Images courtesy of LensAR. Summary Cataract surgery has gone through a number of advancements from extraction of the whole lens through a large incision requiring stitches to the current use of an ultrasound probe to break up, emulsify and remove lens fragments through small sutureless incisions. Such advances in technology, combined with the utilisation of new types of IOLs, have led to a high degree of safety and predictability and contributed to improved outcomes for patients. Although cataract surgery is considered to be safe and efficacious, success is highly dependent on the skill of the surgeon to make the incisions manually, open the capsule and apply ultrasound energy to break up and remove the lens safely. Femtosecond laser technology has been used in corneal procedures for many years now, including the creation of the flap in laser in situ keratomileusis (LASIK). It is now being applied to cataract and lens replacement surgery. In laser-assisted cataract surgery, the laser can be used by the surgeon to make the surgical incisions, create the anterior capsulotomy and break up the crystalline lens. The surgeon then utilises the same techniques as in standard cataract surgery, to remove and replace the lens. It is suggested that this approach offers the potential for even safer and more precise surgery, which could lead to further improvements in clinical outcomes for patients. This paper aims to provide an overview of FLACS and the studies that have attempted to evaluate it. The potential risks, benefits and criteria for patient selection are discussed. 53 A Hartwig et al. 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(2012) Central corneal volume and endothelial cell count following femtosecond laser-assisted refractive cataract surgery compared to conventional phacoemulsification. J Refract Surg 28, 387–91 Talamo JH, Gooding P, Angeley D et al. (2013) Optical patient interface in femtosecond laser-assisted cataract surgery: Contact corneal applanation versus liquid immersion. J Cataract Refract Surg 39, 501–10 3. How is the tissue cut in laser-assisted cataract surgery? (a) Photodisruption (b) Photoablation (c) Photocoagulation (d) Phacoemulsification 4. Which one of the following steps is not performed with the laser during FLACS? (a) Anterior capsulotomy (b) Phacoemulsification Trikha S, Turnbull AM, Morris RJ et al. (2013) The journey to femtosecond laser-assisted cataract surgery: new beginnings or a false dawn? Eye 27, 461–73 (c) Making the incisions Uy HS, Hill W, Edwards KH (2011) Refractive results after laser anterior capsulotomy. ARVO. A4695 Poster D634. Fort Lauderdale, FL 5. Which one of the following steps is not part of the standard FLACS procedure? Uy HS, Edwards KH, Curtis N (2012) Femtosecond phacoemulsification: the business and the medicine. Curr Opin Ophthalmol 12, 33–9 (b) High-resolution imaging Walkow T, Anders N, Pham DT et al. (1998) Causes of severe decentration and subluxation of intraocular lenses. Graefes Arch Clin Exp Ophthalmol 236, 9–12 (d) Postoperative suturing World Health Organization (2010) Global Data on Visual Impairments 2010. Available online at: http://www.who.int/en/ (accessed 1 May 2014) (a) Very small pupil (d) Phacofragmentation (a) Docking the eye (c) Planning the surgery 6. Which of the following may be a relative contraindication for FLACS? (b) Advanced glaucoma (c) Dense corneal opacities CET multiple choice questions This article has been approved for one non-interactive point under the GOC’s Enhanced CET Scheme. The reference and relevant competencies are stated at the head of the article. To gain your point visit the College’s website www.college-optometrists.org/oip and complete the multiple choice questions online. The deadline for completion is 31 July 2015. 1. Which one of the following is a not a potential advantage of FLACS in the removal of cataracts? (a) It is safer (b) It is more precise (c) IOL positioning is better (d) It is suitable for all patients 2. What type of laser is used in FLACS? (a) Nd:YAG (b) Femtosecond (c) Excimer (d) Argon 56 (d) All of the above CPD Exercise After reading this article can you identify areas in which your knowledge of laser-assisted cataract surgery has been enhanced? How do you feel you can use this knowledge to offer better patient advice? Are there any areas you still feel you need to study and how might you do this? Which areas outlined in this article would you benefit from reading in more depth, and why? Laser-assisted cataract surgery: an overview Reflection 1. What impact has your learning had, or might it have, on: • your patients or other service users (eg those who refer patients to you, members of staff whom you supervise)? • yourself (improved knowledge, performance, confidence)? • your colleagues? 2. How might you assess/measure this impact? To access CPD Information please click on the following link: college-optometrists.org/cpd 57
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