Traumatic Aniridia and Aphakia

Home , Aniridia, Aphakia, Glued IOL

CATARACT SURGERY COMPLEX CASE MANAGEMENT Section Editors: Bonnie A. Henderson, MD;Tal Raviv, MD; and Thomas A. Oetting, MS, MD Traumatic Aniridia and Aphakia

BY AMAR AGARWAL, MS, FRCS, FRCOPHTH; DHIVYA ASHOK KUMAR, MD; BORIS MALYUGIN, MD, PHD; DAVID C. RITTERBAND, MD; GABOR B. SCHARIOTH, MD; AND SHACHAR TAUBER, MD

CASE PRESENTATION

A 41-year-old man presents for the surgical correction of aphakia in his left eye. He has a history of trauma to this eye at age 5, followed by “eye surgery” at age 11. The examination reveals an atonic traumatic iris defect (Figure 1). The patient’s refraction is -3.00 D sphere = 20/20 OD and +10.00 -4.00 X 180 = 20/30 OS. Keratometry confirms 4.00 D of with-the-rule corneal astigmatism. His BCVA with a rigid gas permeable contact lens is 20/20 OS, but he is contact lens intolerant. What would you offer this patient for surgical rehabilitation of his aphakia and iris defect? (Courtesy of Tal Raviv,MD.)

Figure 1. An aphakic eye suffered a traumatic loss of iris tissue.

AMAR AGARWAL, MS, FRCS, FRCOPHTH,AND technique1 (Figure 2) and to repair the iris defect. DHIVYA ASHOK KUMAR, MD We would calculate the IOL’s power using the SRK II The case described seems challenging due to the formula with a target of emmetropia. Initially, we would aphakia, high corneal astigmatism, and iris defect. repair the iris defect with a modified McCannel suture2 Without capsular support, the IOL cannot be placed in using 10–0 Prolene (Ethicon, Inc., Somerville, NJ). Next, we the sulcus. Because of the preexisting iris defect, the use of would create two partial-thickness scleral flaps of about an iris claw lens would be difficult. The ideal option here 2.5 mm X 3 mm exactly 180º apart. Either a 23-gauge would therefore be to implant an IOL using the glued IOL sutureless trocar infusion cannula or an anterior chamber ABC (Courtesy of Amar Agarwal,MS,FRCS,FRCOphth, and Dhivya Ashok Kumar,MD.)and Dhivya

Figure 2. In the glued IOL technique, the lens’ haptics are externalized under scleral flaps created through a sclerotomy 1 mm from the limbus (A).The surgeon then tucks the haptics into a scleral pocket created by a 26-gauge needle (B). Fibrin glue seals the haptics to the sclera and seals the scleral flaps (C).

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maintainer could be placed. Using a 20- or 22-gauge nee- significant trauma usually dramatically affects the trabecu- dle, we would make two straight sclerotomies under the lar meshwork. That is why IOP spikes would be highly like- existing scleral flaps about 1 mm from the limbus. A fold- ly in the postoperative period. I would warn the patient able three-piece lens from Abbott Medical Optics Inc. about the possibility that he will need pressure-lowering (Santa Ana, CA), Alcon Laboratories, Inc. (Fort Worth, therapy after surgery, and I would also discuss with him TX), or Bausch + Lomb (Rochester, NY) would be appro- the option of glaucoma surgery. priate. After implanting the IOL through the superior Last but not least, I would try to address this patient’s corneal-limbal incision, we would close the limbal wound high astigmatism by making the clear corneal incision in with 10–0 monofilament nylon sutures. The haptics the superior limbus for the IOL’s implantation. An against- would be externalized and tucked at the edge of the flaps the-rule shift should occur after the suture’s removal. The by means of a tunnel created with a 26-gauge needle. The residual astigmatism should be corrected by spectacles. advantage of a three-piece IOL is that its haptics will not break during externalization. Fibrin glue (Tisseel; Baxter DAVID C. RITTERBAND, MD Healthcare Corporation, Glendale, CA) would seal the First, I would discuss realistic expectations with the haptics to the sclera and seal the flaps. patient. His eye is amenable to surgical correction, but he A limbal incision reduces preexisting astigmatism to a must be aware that more than one surgery may be re- certain level.3 A combination of surgical procedures is quired. He will likely need spectacle correction and some required in challenging cases such as this one to provide astigmatic treatment. He must understand that the good visual and cosmetic results. appearance of his pupil can be improved but that it will neither function normally nor appear “normal.” BORIS MALYUGIN, MD, PHD I do not believe there is enough iris tissue to allow fixa- This patient definitely needs to have an IOL implanted tion of an IOL to the iris through the placement of in his left eye, but the surgeon must first address several McCannel sutures. Scleral fixation of a CZ70BD IOL important issues, including the type of lens and its fixa- (Alcon Laboratories, Inc.) would be necessary and could tion as well as restoration of the iris diaphragm. be performed before possible work on the iris. I would I would suture the IOL to the ciliary sulcus. Which aim for a spherical equivalent of around -3.00 D. Then, a model of IOL to use depends on the technical possibility minimum of 6 weeks after surgery, I would consider per- of performing an iridoplasty in order to restore the forming laser refractive surgery or astigmatic keratotomy diaphragmatic function of the pupil and repairing the iri- to correct the residual cylinder. dodialysis. In Figure 1, the iris is incarcerated in the scleral- If Figure 1 shows all that remains of the iris after the corneal scars, and a significant amount of iris tissue has instillation of a miotic, I do not believe a cosmetic appear- been lost. Based on these findings, it will likely be impossi- ance can be achieved by suturing that rivals the new tech- ble to form the pupil by suturing both parts of the iris. I nology available in Europe and used on a compassionate would therefore implant an iris prosthetic device. basis in the United States. Although the Ophtec model I also have some experience with the PMMA lenses man- 311 aniridia lens (Ophtec BV, Groningen, the Netherlands) ufactured by Morcher GmbH (Stuttgart, Germany; not can be fixated sclerally and provides both an IOL and an available in the United States) that have a black periphery. I artificial iris, it only comes in four color palettes and looks find they work very well but require a large incision for quite synthetic in eyes with residual iris. A more pleasing implantation, so they are not currently my preference. cosmetic appearance could be achieved with a foldable, Here in Russia, a company manufactures the foldable IOL- sutureable artificial iris implant (Artificial Iris; Dr Schmidt iris prosthetic complex in different colors (currently, 16 vari- Intraoculalinsen GmbH, SanktAugustin, Germany; ations) with the results in the peer-reviewed literature.4 I http://artificial-iris.com), the color of which can be cus- have had a good experience with this type of implant in my tomized using photographs of the remaining iris. clinical practice and would probably choose it in this case. An important consideration not discussed in the case GABOR B. SCHARIOTH, MD presentation is the IOP. If it is close to 10 mm Hg, this find- This complex posttraumatic case requires an intensive ing together with the presence of the iridodialysis might preoperative discussion with the patient, because I envi- indicate a ciliary body detachment. In that case, I would sion various options for treatment. perform gonioscopy and/or ultrasonic biomicroscopy pre- My first choice would be a secondary implant with suture- operatively, and if the ciliary body had become detached, I less intrascleral fixation of the haptics.5,6 I would place the would address the problem during the surgical procedure. incision superiorly to reduce the astigmatism. It would be Of course, the IOP may be normal preoperatively, but such very important to have continuous anterior chamber or pars

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(moxifloxacin hydrochloride ophthalmic solution) Systemically administered quinolones including 0.5% as base moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Discontinue use DESCRIPTION: VIGAMOX® (moxifloxacin HCl ophthalmic immediatelyandcontactyourphysicianatthefirstsignofa solution)0.5%isasterileophthalmicsolution.Itisan rash or allergic reaction. 8-methoxyfluoroquinoloneanti-infectivefortopical Drug Interactions: Drug-drug interaction studies have ophthalmic use. not been conducted with VIGAMOX® solution. In vitro CLINICAL PHARMACOLOGY: studiesindicatethatmoxifloxacindoesnotinhibitCYP3A4, Microbiology: CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that plana infusion during surgery to reduce the need for an oph- The following in vitro dataarealsoavailable,but their moxifloxacinisunlikelytoalterthepharmacokineticsof clinical significance in ophthalmic infections is drugs metabolized by these cytochrome P450 isozymes. thalmic viscosurgical device, because the viscoelastic material ® unknown. ThesafetyandeffectivenessofVIGAMOX Carcinogenesis, Mutagenesis, Impairment of Fertility: solution in treating ophthalmological infections due to these Long term studies in animals to determine the carcinogenic would be lost into the vitreous cavity. After the peritomy, I microorganisms have not been established in adequate and potential of moxifloxacin have not been performed. well-controlled trials. However, in an accelerated study with initiators and would create two sclerotomies in the ciliary sulcus, 180º The following organisms are considered susceptible promoters,moxifloxacinwasnotcarcinogenicinrats whenevaluatedusingsystemicbreakpoints.However,a followingupto38weeksoforaldosingat500mg/kg/day from each other, and two limbus-based, parallel, intrascleral correlation between the in vitro systemic breakpoint and (approximately 21,700 times the highest recommended ophthalmologicalefficacyhasnotbeenestablished.Thelist totaldailyhumanophthalmicdosefora50kgperson,on tunnels starting from these sclerotomies. Next, I would inject oforganismsisprovidedasguidanceonlyinassessingthe amg/kgbasis). a three-piece IOL (AR40e; Abbott Medical Optics Inc.) onto potentialtreatmentofconjunctivalinfections.Moxifloxacin Moxifloxacin was not mutagenic in four bacterial strains exhibits in vitro minimalinhibitoryconcentrations(MICs)of2 used in the Ames Salmonella reversion assay. As with the iris’ surface. I would then grasp one haptic with an endo- µg/mlorless(systemicsusceptiblebreakpoint)againstmost otherquinolones,thepositiveresponseobservedwith ≥ ( 90%)strainsofthefollowingocularpathogens. moxifloxacininstrainTA102usingthesameassaymay forceps through a sideport incision and, with a handshake Aerobic Gram-positive microorganisms: beduetotheinhibitionofDNAgyrase.Moxifloxacinwas Listeria monocytogenes not mutagenic in the CHO/HGPRT mammalian cell gene technique, present it to the forceps introduced through the Streptococcus mitis mutation assay. An equivocal result was obtained in the Staphylococcus saprophyticus same assay when v79 cells were used. Moxifloxacin was sclerotomy. It is important to grasp the very tip of the haptic. Streptococcus pyogenes clastogenic in the v79 chromosome aberration assay, but it Streptococcus agalactiae did not induce unscheduled DNA synthesis in cultured rat After externalizing this haptic, I would proceed in the same Streptococcus GroupC,GandF hepatocytes. There was no evidence of genotoxicity in vivo fashion with the second haptic. Then, the goal would be to Aerobic Gram-negative microorganisms: inamicronucleustestoradominantlethaltestinmice. Acinetobacter baumannii Klebsiella pneumoniae Moxifloxacin had no effect on fertility in male and female introduce each haptic with a special 25-gauge forceps Acinetobacter calcoaceticus Moraxella catarrhalis ratsatoraldosesashighas500mg/kg/day,approximately Citrobacter freundii Morganella morganii 21,700 times the highest recommended total daily human (DORC International BV, Zuidland, the Netherlands) into the Citrobacter koseri Neisseria gonorrhoeae ophthalmic dose. At 500 mg/kg orally there were slight Enterobacter aerogenes Proteus mirabilis effects on sperm morphology (head-tail separation) in male limbus-parallel tunnel. With this technique, contact with the Enterobacter cloacae Proteus vulgaris ratsandontheestrouscycleinfemalerats. Escherichia coli Pseudomonas stutzeri Pregnancy: Teratogenic Effects. iris and uvea, tilting and decentration of the lens, and costs Klebsiella oxytoca Pregnancy Category C: Moxifloxacin was not teratogenic Anaerobic microorganisms: when administered to pregnant rats during organogenesis are minimal. I would target a minimally myopic postopera- Clostridium perfringens Prevotella species atoraldosesashighas500mg/kg/day(approximately Fusobacterium species Propionibacterium acnes 21,700 times the highest recommended total daily human tive refraction of about -0.50 to -1.00 D. If the patient desired Other microorganisms: ophthalmic dose); however, decreased fetal body weights an improved refractive result, I could offer refractive corneal Chlamydia pneumoniae Mycobacterium marinum and slightly delayed fetal skeletal development were Legionella pneumophila Mycoplasma pneumoniae observed. There was no evidence of teratogenicity when surgery (ie, LASEK). I have had good results with this Mycobacterium avium pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the approach. Clinical Studies: highest recommended total daily human ophthalmic dose). In two randomized, double-masked, multicenter, controlled An increased incidence of smaller fetuses was observed at Because the case presentation does not indicate that clinicaltrialsinwhichpatientsweredosed3timesaday 100 mg/kg/day. for4days,VIGAMOX® solution produced clinical cures on day5-6in66%to69%ofpatientstreatedforbacterial Sincetherearenoadequateandwell-controlledstudiesin the patient has photophobia, I would not touch the iris ® conjunctivitis. Microbiological success rates for the pregnant women, VIGAMOX solution should be used during in a primary surgery. If needed, in a second attempt, iris eradication of the baseline pathogens ranged from 84% to pregnancy only if the potential benefit justifies the potential 94%. Please note that microbiologic eradication does not risk to the fetus. sutures or an Artificial Iris could be placed. always correlate with clinical outcome in anti-infective trials. Nursing Mothers: Moxifloxacinhasnotbeenmeasuredin INDICATIONS AND USAGE: VIGAMOX® solution is indicated humanmilk,althoughitcanbepresumedtobeexcretedin My colleagues and I have already used the described tech- ® forthetreatmentofbacterialconjunctivitiscausedby human milk. Caution should be exercised when VIGAMOX susceptible strains of the following organisms: solution is administered to a nursing mother. nique for fixating a multifocal IOL. This option would have ® Aerobic Gram-positive microorganisms: Pediatric Use: The safety and effectiveness of VIGAMOX to be discussed with the patient, since he is only 41 years Corynebacterium species* Staphylococcus hominis solutionininfantsbelow1yearofagehavenotbeen Micrococcus luteus* Staphylococcus warneri* established. old. I believe that this approach would require repair of the Staphylococcus aureus Streptococcus pneumoniae Thereisnoevidencethattheophthalmicadministrationof Staphylococcus epidermidis Streptococcus viridans group VIGAMOX® solution has any effect on weight bearing joints, iris defect, and I would select the three-piece Tecnis Staphylococcus haemolyticus even though oral administration of some quinolones has Aerobic Gram-negative microorganisms: been shown to cause arthropathy in immature animals. Multifocal IOL (Abbott Medical Optics Inc.) and bioptics for Acinetobacter lwoffii* Haemophilus parainfluenzae* Geriatric Use: No overall differences in safety and Haemophilus influenzae effectivenesshavebeenobservedbetweenelderlyand the treatment of residual refractive error. Other microorganisms: younger patients. Chlamydia trachomatis ADVERSE REACTIONS: *Efficacyforthisorganismwasstudiedinfewerthan10 Themostfrequentlyreportedocularadverseeventswere SHACHAR TAUBER, MD infections. conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular ® The conservative treatment of a rigid gas permeable con- CONTRAINDICATIONS: VIGAMOX solution is pruritus, subconjunctival hemorrhage, and tearing. These contraindicatedinpatientswithahistoryofhypersensitivity eventsoccurredinapproximately1-6%ofpatients. tact lens has served this patient well for 30 years. It should to moxifloxacin, to other quinolones, or to any of the components in this medication. Nonocularadverseeventsreportedatarateof1-4%were fever, increased cough, infection, otitis media, pharyngitis, not come as a surprise that he has developed intolerance of WARNINGS: rash, and rhinitis. NOT FOR INJECTION. the lens after such a long period. Before embarking on sur- Rx Only VIGAMOX® solution should not be injected subconjunctivally, norshoulditbeintroduceddirectlyintotheanteriorchamber Manufactured by Alcon Laboratories, Inc. gical intervention, however, the treating physician should of the eye. Fort Worth, Texas 76134 USA confirm that all possible medical therapies to reverse con- In patients receiving systemically administered quinolones, Licensed to Alcon, Inc. by Bayer HealthCare AG. includingmoxifloxacin,seriousandoccasionallyfatal U.S.PAT.NO.4,990,517;5,607,942;6,716,830 tact lens intolerance have been attempted, including the hypersensitivity (anaphylactic) reactions have been ©2003, 2004, 2006, Alcon, Inc reported,somefollowingthefirstdose.Somereactions management of blepharitis and dry eye syndrome and the were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, References: use of improved polymers and hybrid lenses. pharyngeal or facial edema), airway obstruction, 1. Kowalski RP, Yates KA, Romanowski EG, et al. An dyspnea, urticaria, and itching. If an allergic reaction to ophthalmologist’s guide to understanding antibiotic Assuming that the patient is a surgical candidate, moxifloxacinoccurs,discontinueuseofthedrug.Serious susceptibility and minimum inhibitory concentration data. acute hypersensitivity reactions may require immediate Ophthalmology. 2005;112:1987-1991. both his aphakia and iris defect will need to be correct- emergency treatment. Oxygen and airway management 2. VIGAMOX® solution prescribing information. ed, preferably in one straightforward surgery. The use of should be administered as clinically indicated. 3. Wolters Kluwer Health, Source® Pharmaceutical Audit Suite, PRECAUTIONS: January 2008-December 2008. an iris color-matched PMMA aniridia lens has been 4. Wagner RS, Abelson MB, Shapiro A, Torkildsen G. Evaluation General: As with other anti-infectives, prolonged use may 7,8 result in overgrowth of non-susceptible organisms, including of moxifloxacin, ciprofloxacin, gatifloxacin, ofloxacin, and shown in several reports to have great success. Re- fungi. If superinfection occurs, discontinue use and institute levofloxacinconcentrationsinhumanconjunctivaltissue.Arch alternative therapy. Whenever clinical judgment dictates, the Ophthalmol. 2005;123:1282-1283. cently, Dr. Agarwal described the use of this device in a patientshouldbeexaminedwiththeaidofmagnification, suchasslit-lampbiomicroscopy,and,whereappropriate, sutureless sulcus-fixated technique in which the haptics fluorescein staining. Patients should be advised not to wear 1 contactlensesiftheyhavesignsandsymptomsofbacterial are secured in a scleral tunnel. conjunctivitis. Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. ©2010 Alcon, Inc VIG10500JA CATARACT SURGERY COMPLEX CASE MANAGEMENT

Preoperatively, I would assess the patient’s risk factors Amar Agarwal, MS, FRCS, FRCOphth, is the for corneal and retinal disease and for glaucoma by means director of Dr. Agarwal’s Group of Eye Hospitals of slit-lamp biomicroscopy, gonioscopy, endothelial cell in Chennai, India. He acknowledged no finan- counts, pachymetry, optic nerve analysis, and a careful cial interest in the products or companies he examination of the macula and peripheral retina. I would mentioned. Professor Agarwal may be reached use immersion biometry and my preferred IOL formula to at +91 44 2811 6233; [email protected]. order the appropriate aniridia lens from the manufacturer. Dhivya Ashok Kumar, MD, is a consultant in Before surgery, the patient would receive a topical non- Dr. Agarwal’s Group of Eye Hospitals in Chen- steroidal anti-inflammatory drug and a fourth-generation nai, India. She acknowledged no financial inter- fluoroquinolone in an effort to prevent cystoid macular est in the products or companies she men- edema and endophthalmitis. At present, aniridia lenses tioned. Dr. Kumar may be reached at +91 44 are made of PMMA and thus are not foldable, so a large, 2811 6233; [email protected]. shelved corneal-scleral incision is needed. I would perform Boris Malyugin, MD, PhD, is a professor of a triamcinolone-assisted vitrectomy, preferably with the ophthalmology and the chairman of the vitreous cutter placed through the pars plana, to ensure Cataract & Implant Surgery Department at the that the anterior chamber was free of vitreous traction. I S. Fyodorov Eye Microsurgery Complex State would then place two sclerotomies under scleral flaps Institution in Moscow. He acknowledged no 180º apart and each 1.5 mm from the limbus. I would financial interest in the products or companies he men- introduce the aniridia lens into the anterior chamber after tioned. Dr. Malyugin may be reached at +7 495 488 8511; filling it with viscoelastic. Each haptic would be external- [email protected]. ized through the sclerotomy and placed through a scleral David C. Ritterband, MD, is a clinical associ- tunnel. Care must be taken with these haptics, because ate professor of opthalmology at The New York their angulation differs from that of most common IOLs. I Eye and Ear Infirmary in New York City. He would close the wound under keratometric control with acknowledged no financial interest in the prod- 10–0 nylon sutures and prescribe an appropriate antibiot- ucts or companies he mentioned. Dr. Ritterband ic steroid and nonsteroidal anti-inflammatory drug. Post- may be reached at [email protected]. operative care would be similar to that for sulcus-fixated Gabor B. Scharioth, MD, is a senior consultant secondary IOL surgery, including careful attention to the at Aurelios Augenzentrum in Recklinghausen, patient’s IOP and an examination of the peripheral retina Germany, and the University of Szeged in and macula. Szeged, Hungary. He acknowledged no financial Although neither the surgery nor the surgical decisions interest in the products or companies he men- required are complex, one issue will cause many US sur- tioned. Dr. Scharioth may be reached at geons to consider delegating this procedure to large insti- [email protected]. tutions: permission to use an aniridia lens requires an Shachar Tauber, MD, is the director of oph- onerous application to the FDA for a human device thalmology research, cornea, and refractive sur- exemption. Fortunately, the companies (Ophtec BV and gery at St. John’s Hospital and Clinics in Morcher GmbH) that produce the iris diaphragm lens as Springfield, Missouri. He acknowledged no well as the endocapsular iris implants have a wonderful financial interest in the products or companies reputation for assisting US surgeons as they complete the he mentioned. Dr. Tauber may be reached at (417) 820- mandated paperwork. I can only hope that, one day 9743; [email protected]. soon, these lenses will be available to US surgeons without this bureaucracy. ■ 1. Agarwal A,Kumar DA,Jacob S,et al.Fibrin glue–assisted sutureless posterior chamber intraocular lens implantation in eyes with deficient posterior capsules.J Cataract Refract Surg.2008;34(9):1433-1438. 2. Blackmon DM,Lambert SR.Congenital iris coloboma repair using a modified McCannel suture technique.Am J Section editor Bonnie A. Henderson, MD, is a partner in Ophthalmol.2003;135(5):730-732. 3. Bayramlar HH,Da lio lu M,Borazan M.Limbal relaxing incisions for primary mixed astigmatism and mixed astig- Ophthalmic Consultants of Boston and an assistant clinical matism after cataract surgery.J Cataract Refract Surg.2003;29(4):723-728. professor at Harvard Medical School. Thomas A. Oetting, MS, 4. Pozdeyeva N,Pashtayev N,Lukin V.Artificial iris-lens diaphragm in reconstructive surgery for aniridia and aphakia. J Cataract Refract Surg.2005;31(9):1750-1759. MD, is a clinical professor at the University of Iowa in Iowa 5. Gabor SG,Pavlidi MM.Sutureless intrascleral posterior chamber intraocular lens fixation. J Cataract Refract Surg. City. Tal Raviv, MD, is an attending cornea and refractive sur- 2007;33(11):1851-1854. 6. Scharioth GB,Prasad S,Georgalas I,et al.Intermediate results of sutureless intrascleral posterior chamber intraocu- geon at the New York Eye and Ear Infirmary and an assistant lar lens fixation. J Cataract Refract Surg.2010;36(2):254-259. professor of ophthalmology at New York Medical College in 7. Moghimi S,Riazi Esfahani M,Maghsoudipour M.Visual function after implantation of aniridia intraocular lens for Valhalla. Dr. Raviv may be reached at (212) 448-1005; traumatic aniridia in vitrectomized eye.Eur J Ophthalmol.2007;17(4):660-665. 8. Dong X,Yu B,Xie L.Black diaphragm intraocular lens implantation in aphakic eyes with traumatic aniridia and [email protected]. previous pars plana vitrectomy.J Cataract Refract Surg.2003;29(11):2168-2173.

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