Refractive Management Volume1: Module 1 Refractive Management Volume 1: Module 1 Please note: The complete product is available online at http://www.aao.org/education/clinicalupdates.cfm This PDF is provided as an additional benefit for your convenience. Refractive Surgery for Myopia, Myopic Astigmatism, and Mixed Astigmatism Nicole J. Anderson, MD, Elizabeth A. Davis, MD, David R. Hardten, MD Objectives Upon completion of this module, the ophthalmologist should be able to 1. Identify and describe current surgical techniques used to correct myopia, myopic astigmatism, and mixed astigmatism, including laser correction, incisional techniques, intrastromal corneal rings, phakic IOLs, and refractive lensectomy. 2. Describe the advantages and disadvantages to each surgical technique for the correction of myopia, myopic astigmatism, and mixed astigmatism. 3. Identify clinical situations where one refractive surgical technique for the correction of myopia, myopic astigmatism, or mixed astigmatism may be preferred to another. Refractive surgical options for the treatment of myopia and myopic astigmatism include laser surgeries, incisional surgeries, intrastromal ring segments, phakic intraocular lenses, and refractive lensectomy. Bioptics, or a planned combination of more than one refractive surgical modality, is also gaining popularity. For mixed astigmatism, several techniques are being used, including astigmatic keratotomy, photorefractive keratectomy, and laser in situ keratomileusis. © www.aao.org 1 Refractive Management Volume1: Module 1 Laser Surgery Photorefractive Keratectomy Photorefractive keratectomy (PRK) was developed in the late 1980s as the first laser vision correction procedure. In October 1995, PRK became the first FDA-approved laser treatment for the correction of myopia and myopic astigmatism. In PRK, a surgeon uses a 193-nm argon fluoride excimer laser to resculpt the surface of the cornea to correct refractive errors. In this procedure, the epithelium is removed by one of several techniques, including • • • • manual scraping rotating brush removal laser ablation followed by manual scraping (laser-scrape) laser ablation (transepithelial) Following the epithelial removal, the laser reticule is centered over the entrance pupil and the laser ablation is performed on Bowman's membrane. The cornea is irrigated with a balanced salt solution, and a bandage contact lens is left in place for 3–7 days, until the epithelium regenerates. Most surgeons treat one eye at a time because functional visual acuity does not return until the epithelium has healed. Depending on the type of laser used, PRK is approved for the treatment of myopia up to -13.0 D and astigmatism up to -4.5 D. PRK is more predictable in patients with a lower degree of myopia (<6.0 D).1-5 Patients with a higher degree of myopia who are treated with PRK tend to have more regression of their refractive effect3,6 and more significant haze.6-8 To minimize haze formation following PRK, surgeons prescribe the use of topical steroids for several months. In larger treatments, the use of antimetabolites to prevent haze formation may be beneficial. Preliminary rabbit and human studies suggest that a single intraoperative application of topical mitomycin C (0.2 mg/mL) may reduce corneal haze associated with PRK.9,10 However, the long-term safety of antimetabolite use in refractive surgery has not been established. Depending on the study and the amount of myopic correction, PRK has been successful in achieving uncorrected visual acuity of 20/40 or better in 67%–98% of patients, with 48%–81% of patients achieving 20/20 uncorrected visual acuity.11-16 Long-term refractive outcomes of PRK and LASIK are similar.46 © www.aao.org 2 Refractive Management Volume1: Module 1 With some patients, PRK may be preferred to LASIK. These patients include those with o o o o o o o o o o o anterior basement membrane dystrophy (ABMD) corneas too thin for LASIK small, deep-set orbits superficial corneal scars very steep or flat keratometry values anterior scleral buckles glaucoma, after trabeculectomy optic nerve disease insufficient corneal thickness a risky occupation or activity suspected keratoconus Contraindications to PRK are o o o o o o o o o an unstable refraction evidence of keratoconus or pellucid marginal degeneration irregular astigmatism on topography autoimmune disease severe dry eye or blepharitis neurotrophism certain medications (ie, isotretenoin, sumatriptan) unrealistic expectations age less than 18 to 21 Relative contraindications to PRK are o o o o o o o o o a history of herpes simplex or zoster pregnancy or lactation immunosupression advanced glaucoma uncontrolled diabetes keloid formation high myopia or astigmatism thin corneas large pupils Complications of PRK are4,6,7,13,15,17-22 o o o o o o o o o o o © www.aao.org under- or overcorrection haze or scaring glare halos loss of contrast irregular astigmatism decentered ablations central islands infectious and noninfectious keratitis reduced corneal sensation reactivation of herpes simplex keratitis 3 Refractive Management Volume1: Module 1 Laser Surgery Laser In Situ Keratomileusis Since the introduction of laser in situ keratomileusis (LASIK) in 1990,23 there have been many reports describing its safety and efficacy.24-26 Uncorrected visual acuity has been reported at 20/40 or better in 46.4%–100% of eyes, depending on the study and degree of myopia.27 Higher refractive errors have less predictable results, resulting in more under- and overcorrections.26,28 Depending on the laser used, LASIK is approved by the FDA for treatments of myopia up to -15.0 D and astigmatism up to -5 D. There have been reports, however, of LASIK being used to treat myopic corrections of -25.0 D or more.29 In LASIK, the microkeratome suction ring increases intraocular pressure to greater than 65–70 mm Hg. This is confirmed by • • • • manual palpation pupil dilation subjective patient response of diminished vision a variety of tonometers The microkeratome is used to make a corneal flap of 130–200 µm. Depending on the type of microkeratome used, either a superior- or nasal-hinged flap can be made. The corneal flap is reflected back toward the hinge, and the stromal bed is dried. The laser reticule is centered on the entrance pupil and the excimer laser ablation is performed (Video 1). Balanced salt solution is irrigated under the flap, which is then stretched back into place and dried. The flap is inspected for lack of striae and symmetry of the peripheral gutters. If the flap or stromal bed is irregular, laser treatment should not be performed. The flap should be left to heal in place, and a new flap can be cut in 6 months. Postoperatively, topical antibiotics and steroids are used for 1–3 weeks. It may take up to 1 month per diopter of correction to achieve refractive stability. An enhancement should not be considered before 3 months, and in most cases it is prudent to wait 6 months. Advantages of LASIK over PRK include • ability to treat a broader range of myopia © www.aao.org 4 Refractive Management Volume1: Module 1 • • • • • more rapid visual recovery less postoperative haze less postoperative discomfort easier enhancement procedure reduced need for long-term steroids Exclusion criteria are the same as for PRK but also include situations that make flap creation difficult, including • • • • • anterior scleral buckles deep-set eyes very steep or flat corneas anterior basement membrane dystrophy glaucoma filtering surgeries Poor exposure (anterior buckles or deep-set eyes) may interfere with the microkeratome pass. Very steep or flat corneas increase the risk of buttonhole formation or free caps, respectively. Anterior basement membrane dystrophy increases the risk of epithelial defects and subsequent lamellar inflammation. In addition, LASIK is not recommended for patients at risk for ectasia, including those with thin corneas, pellucid marginal degeneration, or suspected keratoconus. The current standard of care is that 250 µm of corneal tissue should be left in the stromal bed to minimize the risks of ectasia. However, there have been reports of iatrogenic ectasia even when the residual stromal bed was of sufficient thickness.30,31 Therefore, some surgeons recommend leaving up to 300 µm in the stromal bed.32,33 Laser In Situ Keratomileusis Complications Complications of LASIK can be divided into intraoperative, early postoperative, and late postoperative. Intraoperative Complications Intraoperative complications are estimated to occur in 0.68%–2.1% of cases.34-36 They can be related to the microkeratome or the laser. © www.aao.org 5 Refractive Management Volume1: Module 1 Microkeratome-related complications include34-40 • • • • • • • free caps buttonhole flaps irregular, thin, or incomplete flaps displaced flaps epithelial defects anterior segment perforation intraoperative bleeding Laser complications include39 • • • • • • inadequate laser homogeneity decentration of laser ablation laser malfunction central islands incorrect ablation under- and overcorrection Early postoperative complications include36,38,39 • • • • • • • • flap dislocation flap edema flap striae epithelial defects dry eye interface debris diffuse lamellar keratitis infectious keratitis Late Postoperative Complications include36,38,39,41 • • • • • • epithelial ingrowth night glare and halos irregular astigmatism late corneal haze corneal ectasia visual aberrations, including loss of contrast sensitivity Certain complications can be prevented by careful patient selection. For instance, buttonhole flaps can be minimized by choosing a smaller ring size for steep corneas (>46 D) or performing PRK. Free caps are more common with excessively flat corneas (<41.0 D). The postoperative keratometry value should be considered when planning LASIK because excessively flat corneas (<34.0 D) increase the risk of visual aberrations. © www.aao.org 6 Refractive Management Volume1: Module 1 A postoperative complication unique to LASIK is diffuse lamellar keratitis (Sands of the Sahara syndrome, or DLK). DLK is an inflammatory condition in which white blood cells collect in the interface in a shifting sands' appearance.42 DLK is almost always present on the first postoperative day. Treatment with hourly topical steroids should be instituted. If the cells coalesce on the central cornea (stage III), the flap should be lifted and irrigated. DLK is multifactorial and has been linked to43 • • • • • • sterilizers epithelial defects glove powders endotoxins residual cleaning solutions on the instruments infections Severe or improperly treated cases can result in persistent haze, scarring, and flap melting. The most common postoperative complication of LASIK is the dry eye syndrome. Factors that have been implicated in postoperative dryness include27 • • • neurotrophic epitheliopathy secondary to nerve severance with the microkeratome aqueous tear deficiency poor tear film coverage of the altered corneal surface Laser In Situ Keratomileusis Laser Delivery Patterns These include broad-beam, scanning-slit, and flying-spot. Broad-Beam Lasers Broad-beam lasers deliver a laser beam of a particular diameter through a diaphragm that can expand or contract to modulate the beam size. Typically, the beam begins small and expands as the laser is delivered. The main advantage of broad-beam lasers is a shortened operative time, which results in even stromal hydration throughout the ablation. The main disadvantage is that broad-beam lasers treat all corneas the same and do not take into account corneal asymmetry. Older broad-beam lasers resulted in central islands because the emitted laser plume masked the cornea from successive laser pulses. New laser software addresses this by applying more treatment to the central cornea. © www.aao.org 7 Refractive Management Volume1: Module 1 Scanning Excimer Lasers Scanning excimer lasers, including scanning-slit and flying-spot lasers, provide a much smoother ablation than broad-beam lasers. In addition, the profile can produce aspheric ablations and larger diameter ablations. Scanning lasers can achieve any ablation profile, which is an advantage for irregular or asymmetric corneas. Laser In Situ Keratomileusis Outcomes LASIK outcomes continue to benefit from advancements in technology. Eye-tracking devices rely on infrared lasers or cameras to follow small eye movements and move the laser ablation beam accordingly. Preliminary studies have shown better uncorrected visual acuity, best-corrected visual acuity, and centration in certain patient groups (Hardten DR, McCarty TM, Lindstrom RL, et al. Unpublished data, 2002) with eye-tracking devices. Larger ablation and blend zones may reduce the incidence of glare and halos. Scanning lasers allow the ability to treat irregular asymmetric corneas. Customized corneal ablation is in the forefront. Customized ablation can be guided by topography or by wavefront mapping. Wavefront analysis is able to detect refractive errors at multiple points over the entrance pupil of the eye. It takes into account the whole optical system of the eye and determines how it deviates from a normal wavefront. Wavefront-guided ablation will allow surgeons to customize an ablation for an individual visual system. It will allow for the correction of irregular astigmatism and for the treatment of higher order aberrations and LASIK-induced optical aberrations. Preliminary results with wavefront-guided ablation suggest reduced higher order aberrations and improved visual acuity as compared to results from standard excimer laser surgery. Wavefront sensors are currently available in the United States for diagnostic purposes only. It may be several years before wavefront-guided ablation will be approved for use in the United States. © www.aao.org 8 Refractive Management Volume1: Module 1 Laser Surgery Laser-assisted Subepithelial Keratectomy In recent years, LASIK has become the preferred choice for vision correction because results demonstrate reduced postoperative discomfort and immediate improved postoperative visual acuity. However, as reports of LASIK complications surface,35,44-46 many surgeons and patients are indicating a preference for PRK. Nevertheless, significant postoperative pain, slower visual recovery, and haze remain deterrents to patient and surgeon acceptance of PRK.47-51 Laser epithelial keratomileusis (LASEK) is a recent modification of PRK conceived by Massimo Camellin, MD (Video 2). LASEK may reduce the incidence of postoperative pain, speed visual recovery, and reduce regression and haze when compared to PRK. 52,53 In this procedure, a trephine is used to make an epithelial groove. A reservoir is filled with an alcohol solution and left on the eye for 30–60 seconds. Then a microhoe is used to retract a hinged epithelial flap. Laser treatment is applied directly to Bowman's layer, and the epithelium is replaced and covered by a bandage contact lens. If the epithelium is torn or lost, the procedure is converted to a PRK by removing the residual epithelium. In LASEK, the epithelial covering of the stroma may reduce haze formation and improve postoperative pain as compared to PRK. The advantages of LASEK compared to LASIK include • • eliminating flap complications minimizing risks of corneal ectasia LASEK may be preferred to LASIK in patients with • • • • • • thin corneas and high corrections deep-set eyes steep or flat corneas anterior scleral buckles risky occupations suspected keratoconus It may also be preferred in patients who had previous glaucoma filtering surgery. © www.aao.org 9 Refractive Management Volume1: Module 1 The few published studies to date show encouraging results of this new refractive procedure.52-56 Scerrati et al.55 compared their results from treating two groups of 15 patients with either LASIK or LASEK. The results in the LASEK group were superior to those in the LASIK group when comparing postoperative corneal topography, best spectacle-corrected visual acuity, and contrast sensitivity. Lee et al.53 studied 27 patients with low to moderate myopia in which one eye was treated with LASEK and the other with conventional PRK. At 3-months' follow-up, no between-eye differences in epithelial healing time, uncorrected visual acuity, or refractive error was found. The LASEK eyes, however, had lower pain scores and corneal haze than the PRK eyes. Incisional Surgery Radial Keratotomy Radial keratotomy (RK) is an incisional procedure popularized in the 1970s by Fyodorov. This procedure is performed by making deep radial incisions in the paracentral cornea with a diamond blade (Figure 1). The effect of these incisions is to cause bulging of the peripheral cornea and corresponding flattening of the central cornea. Figure 1. Here, eight radial incisions are made in the cornea during radial keratotomy. Factors that affect surgical outcome include • • • • iameter of the central clear zone number of incisions depth of incisions patient age © www.aao.org 10 Refractive Management Volume1: Module 1 The results of RK are best in patients with low to moderate myopia (up to -6.0 D).57 The Prospective Evaluation of Radial Keratotomy (PERK) study was a multicentered study aimed at evaluating longterm stability after RK. At 10 years following surgery, 38% of patients were within ±0.5 D and 67% of patients were within ±1.0 D of the intended correction. Uncorrected visual acuity was 20/20 or better in 53% of patients and 20/40 or better in 85% of patients. Complications Intraoperative complications of RK include58,59 • • • • • microperforation macroperforation anterior lens perforation invasion of the optical zone intraoperative bleeding Postoperative complications include60-65 • • • • • • • • • • glare epithelial ingrowth endophthalmitis late traumatic ruptured incisions infectious and noninfectious keratitis under- and overcorrection\ induced astigmatism endothelial cell loss diurnal fluctuation in vision difficulty with contact lens fitting One of the most common problems with RK is the instability of the postoperative refraction. Postoperative diurnal fluctuation in vision and progressive hyperopia are common after RK. In the PERK study, 43% of eyes had a hyperopic shift of greater than 1.0 D between 6 months and 10 years following surgery. The hyperopic shift was statistically associated with the diameter of the clear zone, with smaller optical zones inducing more hyperopia.60 Treatment of consecutive hyperopia after RK has proved challenging. Purse-string and interrupted suturing have been described but have not been predictable in most cases.66,67 Photorefractive keratectomy (PRK) has also been tried but is associated with haze.68 Laser in situ keratomileusis (LASIK) after RK is complicated by flap-splitting at the incision sites and epithelial ingrowth into the incisions.69,70 Because of the risk of haze associated with PRK and the flap-associated problems with LASIK, some surgeons are using PRK with intraoperative mitomycin-C in the treatment of postRK hyperopia. © www.aao.org 11 Refractive Management Volume1: Module 1 Few surgeons today perform RK because of advances in excimer laser technology. However, RK has some distinct advantages over modern forms of refractive surgery, including • • • incisions that do not directly involve the optical zone more long-term data on this procedure than on other refractive surgical options equipment that is less expensive than that used in laser surgery Surgeons in communities that do not have access to laser technology may continue to offer RK as a method of correcting mild to moderate myopia. Although today excimer laser surgery is preferred over RK, when surgeons are limited by cost or laser accessibility, RK may still have a small but limited role in the correction of myopia. Incisional Surgery Astigmatic Keratotomy Figure 2. In astigmatic keratotomy, transverse or arcuate incisions are used to flatten the steep corneal meridian and to steepen the flat meridian. Astigmatic keratotomy (AK) is an incisional method of reducing corneal astigmatism (Figures 2, 3). Transverse or arcuate AK incisions are placed in the steep corneal meridian to flatten it and to steepen the flat meridian (coupling). The coupling ratio is defined as the amount of flattening in the steep meridian compared to the amount of steepening in the unincised flat meridian. The coupling ratio depends on the incision's © www.aao.org 12 Refractive Management Volume1: Module 1 Figure 3. A diamond blade is used to make incisions in astigmatic keratotomy. • • • • length type depth location Astigmatic keratotomy can achieve a coupling ratio near 1, so the spherical equivalent remains unchanged. Therefore, AK is a good option for patients with 1.5 to 3.0 D of astigmatism whose spherical equivalent is near plano. Several nomograms for AK determine the cutting parameters based on the primary determinants of refractive effect. Factors that influence the refractive outcome include71-73 • • • • size of optical zone length of incision depth of incision number of incisions © www.aao.org 13 Refractive Management Volume1: Module 1 Incisions are typically placed between a 5-mm-diameter and an 8-mm-diameter zone. Incisions closer to the visual axis cause a greater refractive effect. However, closer incisions (<5.0 mm optical zone) can cause glare, halos, ghosting, and irregular astigmatism.73 Incision length varies from 30° to 90° for arcuate incisions and 2–3 mm for transverse incisions. Depth of the incisions is typically 80%–90% of corneal thickness. Other important factors in the refractive effect achieved are gender, age, and race.74-76 Axis alignment and degree of preoperative astigmatism may also cause variations in the astigmatic correction achieved.77 AK remains an alternative to laser ablation for the correction of naturally occurring astigmatism or after intraocular surgery such as penetrating keratoplasty and cataract surgery. Large-optical-zone AK, which is commonly termed limbal relaxing incisions, is commonly combined with cataract surgery to reduce concomitant astigmatism at the time of small-incision phacoemulsification. Incisional Surgery Automated Lamellar Keratoplasty The importance of automated lamellar keratoplasty (ALK), a technique that has now been largely abandoned, was twofold: 1. It demonstrated that removal of central corneal tissue would result in corneal flattening and the correction of myopia. 2. The invention of the automated microkeratome by Luis Antonio Ruiz allowed the creation of a corneal lamellar flap dissection. In this technique, the microkeratome makes two refractive cuts into the anterior to mid stroma, producing a disk of stromal tissue. The disk is excised and the overlying flap is repositioned. The thickness of the excised corneal tissue determines the amount of correction. The ALK technique has been largely abandoned due to its poor predictability, a small effective optical zone, irregular astigmatism, and regression.78-80 New generation microkeratomes and the accuracy of laser ablation has made LASIK a much more predictable procedure.80 © www.aao.org 14 Refractive Management Volume1: Module 1 Intrastromal Corneal Ring Segments Intrastromal corneal rings (Intacs, Addition Technology, Fremont, CA) were approved by the US Food and Drug Administration in April 1999. Intacs consists of two 180° polymethylmethacrylate (PMMA) ring segments that are inserted into the midperipheral cornea at two-thirds corneal depth (Figure 4). A 1.2-mm corneal incision is made, and a lamellar dissecting instrument is rotated in each direction to create two intrastromal channels (Video 3). Ring thicknesses of 0.21 mm and 0.25-0.45 mm (in 0.5-mm increments) are available and are inserted into the channels (Video 4). Increasing ring thickness produces a shorter arc length and further central corneal flattening.81,82 Figure 4. Two arc-shaped polymethylmethacrylate (PMMA) ring segments The prolate aspheric shape of the cornea is maintained in this procedure because the central corneal tissue is not treated. Maintenance of corneal sphericity may be beneficial in reducing spherical aberrations, glare, and contrast loss.83,84 In the phase II and III clinical trials, 97% of patients had 20/40 or better uncorrected visual acuity and 76% had 20/20 or better uncorrected visual acuity at 24 months' follow-up.85,86 Intacs are approved only for the treatment of mild myopia (-1.0 to-3.0 D spherical equivalent) with little or no astigmatism (<1.0 D). © www.aao.org 15 Refractive Management Volume1: Module 1 Intrastromal Corneal Ring Segments Advantages An advantage of Intacs over laser ablation is that the original rings can be replaced with a different ring size at a later time to revise the correction. Furthermore, the refractive effect may be reversible after removal of the ring segments. In the phase II and III FDA clinical trials, 4.7% of eyes had explantation of their ring segments. At 3 months following explantation, 86% of these eyes returned to within ±0.5 D and 95% returned to within ±1.0 D of preoperative spherical equivalent refraction.86 Reasons for lens removal include86-88 • • • • • • glare halos night vision problems infection induced astigmatism patient dissatisfaction Advantages of Intacs over LASIK • • • • maintenance of the prolate shape of the cornea to reduce spherical aberration preservation of the central corneal tissue reversibility adjustability LASIK, however, still remains the most common choice among refractive surgeons for the correction of mild myopia because of • • • • • ease rapid visual recovery ability to do bilateral simultaneous surgery ability to treat astigmatism predictability Because only 5 different sizes of Intacs are available, essentially only 5 prescriptions are available, whereas with excimer laser correction, an unlimited degree of precision is available. Intrastromal Corneal Ring Segments © www.aao.org 16 Refractive Management Volume1: Module 1 Complications Complications of Intacs include87,89-91 • • • • • • • • • • • • over- or undercorrection induced astigmatism epithelial defects corneal thinning infectious keratitis epithelial inclusion cysts segment migration neovascularization channel haze glare halos anterior or posterior perforation Mean induced astigmatism in the FDA trials was 0.13 D at 12 months. The astigmatism was more frequently with-the-rule than against-the-rule and appeared to increase with segment thickness.91 Phakic Intraocular Lenses Phakic intraocular lenses (IOLs) are a new technology for the correction of high refractive errors. They include both anterior and posterior chamber varieties. The main anterior chamber IOLs under investigation are • • the Artisan lens (Ophtec USA Inc./Allergan, Boca Raton, FL) the Baikoff NuVita MA20 lens (Bausch and Lomb Surgical, Irvine, CA) The two main posterior chamber IOLs under investigation are • • the Implantable Contact Lens (ICL, STAAR Surgical, Monrovia, CA) the Phakic Refractive Lens (PRL, Medennium, Inc/CibaVision, Atlanta, GA Phakic Intraocular Lenses Artisan Lens © www.aao.org 17 Refractive Management Volume1: Module 1 The Artisan anterior chamber lens was designed by Jan Worst and has been used in the Netherlands for 12 years. The Artisan lens is an 8.5-mm one-piece PMMA lens with a 6.0-mm optic. It is an iris-supported IOL, with fixation to the peripheral iris stroma.92-98 The optic is convexconcave, which ensures vaulting over the natural lens after insertion. Fixation of the lens to the iris is achieved by lifting a fold of iris stroma through an opening in the haptics in a process called enclavation (Video 5). Clinical investigation of the Artisan lens in the United States reported that 97% of eyes were 20/40 or better uncorrected at 6 months, where the postoperative goal was ±0.5 D of emmetropia, monovision eyes were eliminated, and postoperative cylinder was <1.0 D.99 Compared to LASIK, the Artisan lens may provide100 • • • improved contrast sensitivity lower enhancement rates ability to remove or exchange the lens Complications include101-103 • • • • • iridocyclitis iris atrophy lens dislocation pupil ovalization decreased corneal endothelial cell density The incidence of cataract formation is very low because of the position of the lens in the anterior chamber away from the anterior surface of the crystalline lens. The lens is made in powers ranging from -5 to -20 D. Phakic Intraocular Lenses NuVita MA20 Lens The NuVita MA20 anterior chamber lens (formerly the Baikoff ACIOL) is a PMMA lens with a fourpoint fixation into the anterior chamber angle (Figure 5).104 There is little difference between implantation of this lens and other anterior chamber lenses used for the correction of aphakia. This lens is sized by measuring the horizontal white-to-white limbal diameter and adding 0.5–1.0 mm. © www.aao.org 18 Refractive Management Volume1: Module 1 Lens size is important to prevent late ovalization of the pupil or migration of the implant. The lens is available in powers ranging from -7.0 to -20.0 D and sizes ranging from 12.0 to 13.5 mm. Figure 5. The NuVita MA20 is an anterior chamber intraocular lens. © www.aao.org 19 Refractive Management Volume1: Module 1 Complications are105 • • • • • pupil ovalization glare iridocyclitis implant migration endothelial cell loss In one study, endothelial cell loss of 12% occurred at 2 years following implantation of the NuVita lens.105 Phakic Intraocular Lenses Implantable Contact Lens The Implantable Contact Lens (ICL) is a foldable collamer posterior chamber lens made from a mixture of hydrogel and collagen polymer (collagen 0.3%/2-hydroxyethyl- methacrylate).106 It is very thin (50 µm at the optical zone), permeable, and hydrophilic. It is placed through a 3-mm clear corneal incision between the iris and the natural crystalline lens (Videos 6, 7). The lens is 10.8–13 mm long, with optic sizes ranging from 4.5 to 5.5 mm. The myopic powers range from -3.0 to -20 D. It has been found in several studies to be a safe and effective treatment of myopic refractive errors, with 67%–81% of patients falling within ±1.0 D of intended correction postoperatively.107-109 Complications specific to this lens include106,109-111 • • • • • • cataract formation pupillary entrapment decreased endothelial cell density crystalline lens touch increased aqueous flare pupillary block In addition, natural crystalline lens transmittance of light appears to decrease over time.111 Furthermore, peripheral posterior chamber phakic intraocular lens and crystalline lens touch has occurred in up to 60% of patients in one study.111 Trace trabecular meshwork pigmentation has been found, but this has not been correlated with increased IOP or pigmentary glaucoma.112 © www.aao.org 20 Refractive Management Volume1: Module 1 Phakic Intraocular Lenses Phakic Refractive Lens The Phakic Refractive Lens (PRL) is a one-piece hydrophobic silicone plate-haptic posterior chamber IOL. It is foldable and can be inserted through a 3.5-mm clear corneal incision. It is designed to be independent of intraocular support for fixation and floats on an aqueous fluid layer over the natural crystalline lens. The lens powers to treat myopia range from -3 to -20 D. Advantages Phakic IOLs offer several advantages over incisional or laser surgeries. The preservation of corneal sphericity may improve contrast sensitivity and diminish optical aberrations. In patients with high myopia, large ablations and small ablation zones may increase visual aberrations and place the patient at risk for corneal ectasia. Patients who are not good candidates for LASIK may be candidates for phakic IOLs. However, large pupil size and insufficient anterior chamber depth can be limiting factors for patient selection for these lenses. Disadvantages Disadvantages of phakic IOLs include • • • • • pupil ovalization in some models cataract formation iritis endothelial cell loss complications related to any intraocular surgery Preoperative or intraoperative peripheral iridectomies are required in all patients. Currently, phakic IOLs are in phase III FDA clinical trials and approval is anticipated in the next couple of years. Refractive Lensectomy Refractive lensectomy, or clear lens extraction, is the removal of the natural crystalline lens for the treatment of high refractive errors. A monofocal or multifocal lens implant is inserted based on the © www.aao.org 21 Refractive Management Volume1: Module 1 desired refractive outcome. Refractive lensectomy has been used for the correction of myopia, hyperopia, and presbyopia. Refractive lensectomy is essentially the same surgical procedure as cataract extraction and has the same complications, including113-117 • • • • • • endophthalmitis secondary glaucoma cystoid macular edema posterior capsular opacification loss of accommodation retinal detachment Retinal detachment remains a significant concern when performing refractive lensectomy on patients with high myopia. In a group of 41 eyes with retinal detachment after clear lens extraction, only 9 eyes achieved final visual acuity of 20/60 or better.118 Retinal detachment rates after refractive lensectomy vary from 1.9% to 8.1%, depending on the study and time to follow-up.114116,119 Patients with high myopia have a higher incidence of retinal detachment than the general population.120 These patients account for 42% of rhegmatogenous retinal detachments despite being only 10% of the population. Patients with myopia who undergo lens extraction and Nd:YAG capsulotomy may further increase their risk of retinal detachment. Barraquer et al. found a clear association between Nd:YAG laser posterior capsulotomy and retinal detachment (11% with YAG capsulotomy vs. 5.5% without YAG capsulotomy) in eyes undergoing refractive lensectomy.116 Clinically significant posterior capsule opacification requiring Nd:YAG capsulotomy after refractive lensectomy ranges from 8% to 61%, depending on the study and time of follow-up.114,115,121 Refractive lensectomy is a viable option for refractive correction at high extremes of ametropia, but caution should be exercised in cases of high axial myopia. Refractive lensectomy is a good option for patients who have corneas too thin or irregular for corneal refractive surgery. Furthermore, patients with evidence of early nuclear sclerosis may be better candidates for refractive lensectomy if cataract extraction would be anticipated in the next several years. © www.aao.org 22 Refractive Management Volume1: Module 1 Bioptics Bioptics, popularized by Roberto Zaldivar, is the planned combination of phakic or aphakic intraocular lens surgery with corneal surgery to correct large refractive errors. Typically, the maximum IOL power is used, and the undercorrection is corrected by corneal ablation surgery (PRK or LASIK). The surgeries can be staged with the lens surgery performed first, followed later by PRK or LASIK. Alternatively, the LASIK flap can be made at the time of the lens surgery and lifted several weeks later for laser ablation. Bioptics can be performed with either phakic IOLs or clear lens extraction. Preliminary results with these techniques have been encouraging for high myopia.122-126 Bioptics is especially useful in patients with high myopia, as traditional IOL calculations can be less accurate secondary to long axial lengths, posterior staphylomas, reduced accuracy of lens power calculations, and vertex distance adjustments. Bioptics is often preferable to laser ablation alone because of the reduced risk of visual aberrations, contrast loss, glare, and halos that are associated with extremely large myopic excimer laser ablations. In addition, the increased tissue ablation and smaller optical zones necessary with large myopic corrections decrease the predictability and stability of laser refractive surgery. Potential complications of bioptics are complications of the corneal and intraocular lens surgery. Mixed Astigmatism In mixed astigmatism, one focal line is projected in front of the retina while the other focal line is projected behind the retina. Therefore, the spherical equivalent is near plano. Several surgical techniques can be used to treat mixed astigmatism, including incisional surgery, such as astigmatic keratotomy (AK), and laser surgery, such as photorefractive keratotomy (PRK) and laser in situ keratomileusis (LASIK). In AK, transverse or arcuate incisions are placed in the steep corneal meridian to flatten the steep meridian and steepen the flat meridian (coupling). The coupling ratio is defined as the amount of flattening in the steep meridian compared to the amount of steepening in the unincised flat meridian. The coupling ratio depends on the incision's © www.aao.org 23 Refractive Management Volume1: Module 1 • • • • length type (arcuate or tranverse) depth location as well as on the number of incisions. Astigmatic keratotomy can achieve a coupling ratio near 1, meaning the spherical equivalent remains unchanged.127,128 It is, therefore, an ideal procedure for patients with mixed astigmatism. Both PRK and LASIK are also used for the correction of mixed astigmatism. Many excimer lasers now have software programs for treating it. Previously, the surgeon could decide to treat mixed astigmatism in one of four ways: 1. Negative cylinder ablation flattens the steep axis first, with a myopic cylinder ablation. The resulting hyperopia is treated with a spherical hyperopic ablation. 2. Positive cylinder ablation steepens the flat axis first and then flattens both axes with a myopic spherical ablation. 3. Cross-cylinder approach treats half the cylinder in the steep meridian and half in the flat meridian. The remaining spherical equivalent is then treated. 4. Bitoric ablation treats the entire cylindrical correction, leaving no spherical equivalent to treat. A negative cylinder ablation is used to flatten the steep axis and then a positive cylinder ablation steepens the flat axis. Because there is no compensatory spherical ablation, more corneal tissue is preserved. Some authors have found no difference in outcomes among positive cylinder, negative cylinder, and bitoric ablations.129 Other authors have found a reduced frequency of reablation with bitoric ablations compared with monotoric ablations.130 Furthermore, bitoric ablations have the advantage of removing less tissue and possibly improving optics.131 In comparing LASIK and AK for the treatment of mixed astigmatism, Chayet and colleagues achieved a 91% decrease in the amount of preexisting astigmatism after treating it with bitoric LASIK.132 This compares with only a 72% cylinder reduction after the same authors treated mixed astigmatism with AK.128 Other authors have found no significant difference in outcomes between AK and LASIK.133 The current trend is toward treating mixed astigmatism with LASIK because of the availability and improvements in laser software. In the FDA clinical trials of VISX's (VISX Inc, Santa Clara, CA) mixed astigmatism software, 99.1% of eyes treated achieved uncorrected visual acuity of 20/40 or better and 61.28% achieved 20/20 or better at 6 months' posttreatment. © www.aao.org 24 Refractive Management Volume1: Module 1 References 1. Sher NA, Barak M, Daya S, et al. Excimer laser photorefractive keratectomy in high myopia. A multicenter study. Arch Ophthalmol 1992;110:935–943. 2. Hersh PS, Schein OD, Steinert R. Characteristics influencing outcomes of excimer laser photorefractive keratectomy. Summit Photorefractive Keratectomy Phase II Study Group. Ophthalmology 1996;103:1962–1969. 3. Gartry DS, Kerr Muir MG, Marshall J. Photorefractive keratectomy with an argon fluoride excimer laser: a clinical study. J Refract Corneal Surg 1991;7:420–435. 4. Seiler T, Wollensak J. Results of a prospective evaluation of photorefractive keratectomy at 1 year after surgery. Ger J Ophthalmol 1993;2:135–142. 5. Goes FJ. 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Complications of laser in situ keratomileusis for the correction of myopia. Ophthalmology 1999;106:13–20. 35. Gimbel HV, Penno EE, Van Westenbrugge JA, et al. Incidence and management of intraoperative and early postoperative complications in 1000 consecutive laser in situ keratomileusis cases. Ophthalmology 1998;105:1839–1847. 36. Tham VM, Maloney RK. Microkeratome complications of laser in situ keratomileusis. Ophthalmology 2000;107:920–924. 37. Pallikaris IG, Katsanevaki VJ, Panagopoulou SI. Laser in situ keratomileusis intraoperative complications using one type of microkeratome. Ophthalmology 2002;109:57–63. 38. Melki SA, Azar DT. LASIK complications: etiology, management, and prevention. Surv Ophthalmol 2001;46:95–116. 39. Ambrosio R Jr, Wilson SE. Complications of laser in situ keratomileusis: etiology, prevention, and treatment. J Refract Surg 2001;17:350–379. 40. Lin RT, Maloney RK. Flap complications associated with lamellar refractive surgery. Am J Ophthalmol 1999;127:129–136. 41. Moreno-Barriuso E, Lloves JM, Marcos S, et al. Ocular aberrations before and after myopic corneal refractive surgery: LASIK-induced changes measured with laser ray tracing. Invest Ophthlmol Vis Sci 2001;42:1396–1403. 42. Smith RJ, Maloney RK. Diffuse lamellar keratitis. A new syndrome in lamellar refractive surgery. Ophthalmology 1998;105:1721–1726. 43. Linebarger EJ, Hardten DR, Lindstrom RL. Diffuse lamellar keratitis: identification and management. Int Ophthalmol Clin 2000;40:77–86. 44. Hersh PS, Brint SF, Maloney RK, et al. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study. Ophthalmology 1998;105:1512–1522; discussion 1522–1523. 45. Wang Z, Chen J, Yang B. Posterior corneal surface topographic changes after laser in situ keratomileusis are related to residual corneal bed thickness. 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