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      Canaloplasty:                                                                    November 2011
                                                                   Sponsored by iScience Interventional




      The Keys
      to Optimizing
      Patients’ Outcomes




                                                   Supplement to
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      Canaloplasty: The Keys to Optimizing Patients’ Outcomes




         Canaloplasty:
         The Keys
         to Optimizing
         Patients’ Outcomes
        T
                  he introduction of canaloplasty into      PANEL
                  the glaucoma surgical armamentarium
                  was motivated by the desire of clini-     Steven D. Vold, MD, (moderator) is in private practice
                  cians to enhance the quality of           with Vold Vision in Bentonville, Arkansas. He is a consult-
        patients’ glaucoma care. Patients’ long-term        ant to and clinical investigator for iScience Interventional.
        adherence to topical glaucoma medical therapy       Dr. Vold may be reached at (479) 246-1700;
        is well known to be relatively poor. Laser thera-   svold@cox.net.
        py offers a safe alternative to medical therapy     Howard Barnebey, MD, is medical director and CEO of
        but often still requires the addition of topical    Specialty Eyecare Centres in Seattle. He is medical
        medication. Traditionally, glaucoma filtration      advisor for iScience Interventional. Dr. Barnebey may
        surgery has been reserved for more advanced,        be reached at (206) 621-8407;
        uncontrolled glaucoma for obvious reasons.          hbarnebey@specialtyeyecarecentre.com.
        Despite its definite role in glaucoma care,
        patients undergoing standard trabeculectomy         Michael Morgan, MD, is the chairman of the
        are at significant risk for the development of      Department of Ophthalmology at Ochsner Clinic
        postoperative infection, cataract, hypotony, bleb   Foundation in Baton Rouge, Louisiana, and an associate
        dysesthesia, astigmatism, and decreased visual      faculty member of the Louisiana State University Medical
        acuity. These potential complications have driv-    Science Center’s Department of Ophthalmology. He
        en surgeons to pursue surgical alternatives.        acknowledged no financial interest in the products or companies
           Canaloplasty is a well-established procedure     mentioned herein. Dr. Morgan may be reached at (225) 761-5400;
        that has, for the past 3 years, demonstrated        mimorgan@ochsner.org.
        impressive efficacy and safety in peer-reviewed
                                                            David Richardson, MD, is the medical director of San
        prospective studies. Despite growing evidence of
                                                            Gabriel Valley Eye Associates, Inc., in San Gabriel,
        its value and increasing performance of the pro-
                                                            California. He is a consultant to iScience Interventional.
        cedure by ophthalmologists all over the world,
                                                            Dr. Richardson may be reached at (626) 289-7856;
        misconceptions regarding its long-term efficacy
                                                            david.richardson@sangabrieleye.com.
        as well as challenges in its adoption, surgical
        technique, and patient selection persist. Several   Steven R. Sarkisian Jr, MD, is the director of the glaucoma
        experienced and leading surgeons share their        fellowship at The Dean A. McGee Eye Institute and a
        experiences and pearls for optimizing success       clinical associate professor of ophthalmology at the
        with canaloplasty.                                  University of Oklahoma in Oklahoma City. He is a con-
                                                            sultant to and clinical investigator for iScience
                                  — Steven D. Vold, MD      Interventional. Dr. Sarkisian may be reached at
                                                            (405) 271- 1093; steven-sarkisian@dmei.org.


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                                                            Canaloplasty: The Keys to Optimizing Patients’ Outcomes


        Please briefly describe your early experience with
                                                                                “Any procedure can be challenging, but
        and approach to adopting canaloplasty.
           Dr. Richardson: I was comfortable with the basic ele-                the learning curve for a surgeon who is
        ments of the procedure after performing about a 1/2 dozen               well versed in trabeculectomy and who
        cases. As with any surgery, however, there are skills that can-             understands the anatomy of the
        not be mastered until the steps become nearly habitual.                   anterior segment of the eye is easier
        Essential to the development of any habit or skill is repeti-                 than the learning curve for
        tion within a short time frame. A key reason I became com-
                                                                                         phacoemulsification.”
        fortable with canaloplasty early on is I grouped my first
        dozen cases over just a few months so I did not have to                                  —Howard Barnebey, MD
        “relearn” the procedure with each scheduled canaloplasty.
        Also worth mentioning is the clinical education offered by           was already familiar with the canalicular anatomy. However,
        iScience is unprecedented in terms of the wet lab prepara-           with the exception of the deep sclerectomy, most of the
        tion, in-surgery and in-person support, and the postopera-           steps in performing canaloplasty are familiar to any surgeon
        tive telephone support. Support from iScience gets you               who has done a trabeculectomy.
        past the initially steep learning curve. After that, it is easy to
        discuss cases with multiple canaloplasty surgeons around             Some surgeons have suggested that the learning
        the United States who are all eager to share their experi-           curve for canaloplasty can be challenging.Would
        ences. Once you master canaloplasty, you tend to get excit-          you agree or disagree with this statement?
        ed about sharing this procedure, so the support from more               Dr. Richardson: The steps involved in canaloplasty are
        experienced surgeons is always readily available.                    new for most surgeons, so of course, there is going to be a
                                                                             learning curve. Does that learning curve compare to the ini-
           Dr. Morgan: In order to successfully adopt canaloplasty, I        tial curve required to become competent at phacoemulsifi-
        studied the principles of deep sclerectomy very intensely by         cation? It is not even close. Like phacoemulsification,
        watching videos and strictly adhering to the following               canaloplasty requires finesse and an understanding of the
        guidelines:                                                          local anatomy, but there are fewer steps involved (as well as
           • Find the correct depth at the apex of the deep dissec-          fewer points during which you can get yourself into trou-
        tion by cutting right down to the ciliary body. You can do           ble). Any cataract surgeon who no longer gets nervous
        this safely by slowly working your way down with the super-          making a capsulorhexis or who regularly polishes the cap-
        sharp blade until the ciliary body is encountered.                   sule can master canaloplasty. Handling Descemet mem-
           • Once the correct depth has been found, back up a few            brane is not so different from dealing with the capsule. That
        fibers and advance. This is the correct plane to access              said, I would not recommend canaloplasty to an inexperi-
        Schlemm canal.                                                       enced surgeon who is not yet comfortable touching the
           • Stay in the same plane, especially when you approach            bare capsule with an instrument.
        the scleral spur. Avoid the temptation to hasten the process
        by deepening the plane when you get close to the spur.                  Dr. Morgan: It is important for the prospective surgeon
                                                                             to realize that the barriers to adoption are largely mental.
           Dr. Barnebey: Like with most new procedures, my learn-            Most accomplished phaco surgeons already possess the
        ing curve did not occur overnight or in a single step. I             skills necessary to perform the procedure. The techniques
        learned the fundamentals of performing a good trabeculec-            are not more difficult than complex, small-pupil pha-
        tomy during my fellowship. In the early 1990s, a variation on        coemulsification, but because the required surgical maneu-
        the trabeculectomy was introduced as a deep sclerectomy              vers are new to the surgeon, they are intimidating. This can
        and later as a viscocanalostomy. I honed my skills doing             make surgeons afraid to try the procedure. If they begin
        these procedures and had respectable results. The introduc-          with the right patient population, the stress can be greatly
        tion of canaloplasty was another building block.                     minimized.
        Scientifically, the introduction of a catheter with 360° vis-
        codilation and placement of a retaining stent was a dramat-             Dr. Barnebey: Any procedure can be challenging, but the
        ic step in the advancement of the surgery. The addition of           learning curve for a surgeon who is well versed in tra-
        the microcatheter and stent was an incremental additional            beculectomy and who understands the anatomy of the
        step with a relatively brief learning curve.                         anterior segment of the eye is easier than the learning curve
           Dr. Sarkisian: I personally started the canaloplasty adop-        for phacoemulsification.
        tion process rather slowly. After 10 to 15 cases, I began
        developing confidence in the procedure. I had been per-                 Dr. Sarkisian: The learning curve is challenging but not
        forming trabeculotomies on children for some time, so I              insurmountable. Trabeculectomy provides the basic skill set

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      Canaloplasty: The Keys to Optimizing Patients’ Outcomes


        for performing canaloplasty. The main new things are isolat-
        ing Schlemm canal and fashioning the trabeculo-Descemet                  “Canaloplasty allows me to provide
        window.                                                                  surgery to patients who previously
                                                                                   would have received only topical
           Dr. Vold: From my perspective, the challenges associated              medication or laser trabeculoplasty. I
        with canaloplasty are overstated. Experienced surgeons
        should have little difficulty adopting this procedure. The
                                                                                  feel that canaloplasty represents a
        keys to successfully adopting canaloplasty are being knowl-                significant advance in glaucoma
        edgeable of the angle anatomy and having the ability to                  surgery by allowing me to treat the
        fashion quality scleral dissections. Threading the iTrack                  earlier phases of glaucoma more
        microcatheter (iScience Interventional, Menlo Park, CA) is               aggressively and more definitively.”
        relatively easy once Schlemm canal has been isolated.
        Without question, quality anterior segment surgeons
                                                                                              —Steven R. Sarkisian Jr, MD
        should have little difficulty successfully performing canalo-
        plasty.                                                             aged by your improved results to press on and perform
                                                                            more cases. You then begin to get more aggressive in find-
        What advice would you give to your colleagues to                    ing patients who are good candidates earlier in their treat-
        make the learning process easier?                                   ment algorithm.
           Dr. Richardson: Familiarize yourself with the steps
        involved in canaloplasty. Read the materials provided by            Before you started offering canaloplasty to your
        iScience. Do a search on YouTube and watch some of the              patients, what was your greatest concern about per-
        videos. Then, memorize the steps and mentally perform               forming this procedure?
        the surgery before your first case. Many experienced sur-             Dr. Richardson: I had two main concerns. First, would I
        geons forget that they must prepare and practice mentally if        be able to do it? Dissecting the trabeculo-Descemet win-
        they are going to succeed physically. Surgeons are no differ-       dow sounds nearly impossible to someone who has never
        ent (or better) than athletes in this manner. Show me a golf        done such a thing. Funny, that is probably what I would
        professional who has not at least “walked” the course prior         have thought about polishing the posterior capsule years
        to the tournament, and I will show you someone who has              ago (something I routinely do now). Second, will I harm my
        no chance of winning the purse.                                     patient? I quickly learned that canaloplasty is a very forgiv-
                                                                            ing surgery. It is as near to a “no harm, no foul” glaucoma
           Dr. Morgan: The key to reducing the initial stress is in         surgery as I have ever experienced. Is it totally without risk?
        choosing the right patients for your early cases. I strongly        Of course not, but compared to the bleb-dependent glau-
        recommend choosing patients who are undergoing a                    coma surgeries, it is in a league of its own.
        cataract procedure at the same time and do not desperately
        need an extremely low IOP. The typical cataract and glauco-           Dr. Morgan: I had to come to terms with the fact that I
        ma patient on two or more medications is the ideal patient          might not succeed. Ophthalmologists are generally very
        to start on. If the procedure is not successful, the patient will   accomplished individuals. They are not comfortable with
        still be happy with the results of the cataract surgery. On the     the prospect of failure. Once I accepted that I might not
        other hand, a successful canaloplasty procedure will reduce         succeed, I was ready to move forward. It is helpful to have a
        his or her dependence on medications, which will further            comfortable backup plan in your mind, such as implanting
        enhance the outcome.                                                an Ex-Press Glaucoma Filtration Device (Alcon Laboratories,
                                                                            Inc., Fort Worth, TX) or performing trabeculectomy.
          Dr. Barnebey: Deliberate, focused study and practice are
        necessary. Break the procedure into manageable steps and              Dr. Sarkisian: My early concern was making a good tra-
        focus on understanding and mastering each of those steps            beculo-Descemet window, but the new canaloplasty instru-
        based on your individual skill set and experience. It is also       mentation by Mastel Precision, Inc., (Rapid City, SD) makes
        important to latch onto a mentor who can help guide you             performing this part of the procedure much easier for sur-
        through the process.                                                geons who are new to canaloplasty.

          Dr. Sarkisian: You have to jump in with both feet. Get            How has canaloplasty influenced your treatment
        past the learning curve in the first 2 months. It generally         paradigm for glaucoma patients?
        takes 10 to 15 cases. The more canaloplasty cases you per-            Dr. Richardson: I now move directly from maximum tol-
        form, the better you get. Just like when learning phaco for         erated medical therapy to canaloplasty without bothering
        the first time, you soon get more confident and are encour-         with laser trabeculoplasty.

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                                                          Canaloplasty: The Keys to Optimizing Patients’ Outcomes



           Dr. Morgan: Canaloplasty has totally changed how I treat             “The key to reducing the initial stress
        glaucoma patients. I now have a safe and effective glaucoma              is in choosing the right patients for
        procedure that I can perform early in the disease process.             your early cases. I strongly recommend
        We know from evidence-based glaucoma studies, such as                   choosing patients who are undergo-
        the Early Manifest Glaucoma Treatment Trial, that earlier
        intervention is better.1 The problem we have had to deal                ing a cataract procedure at the same
        with is that we did not have a truly safe glaucoma proce-               time and do not desperately need an
        dure. For this reason, we hesitated to treat patients whom                        extremely low IOP. ”
        we knew would be better off with a lower IOP. In the past, I                             —Michael Morgan, MD
        intervened surgically only when absolutely necessary. Now, I
        can confidentially treat patients much sooner, and this
        allows me to provide superior care.                                therapy, but I have yet to see a patient on two to three dif-
                                                                           ferent drops who is really “tolerating” the treatment well.
           Dr. Barnebey: It is always wonderful to have choices, since     Between ocular surface issues, systemic side effects, and the
        there is no single procedure that is appropriate for all glau-     cost of treatment, most patients on more than one or two
        coma patients. Canaloplasty provides a minimally invasive          separate drops really need a better alternative therapy.
        strategy by which to re-establish aqueous outflow with
        minimal-to-no violation of the anterior chamber; good, sus-           Dr. Morgan: Canaloplasty has been most effective for me
        tained IOP-lowering efficacy; a safer complication profile;        in patients who present with moderately elevated IOPs of
        and the prospect of avoiding the long-term challenges of a         around 35 mm Hg without medication. Also, it appears that
        conjunctival bleb.2,3                                              patients who respond to medications initially, but not
                                                                           enough to eliminate their risk of vision loss, are the best can-
           Dr. Sarkisian: Canaloplasty is now my procedure of              didates. These patients, I reason, have some trabecular out-
        choice for baby boomers, monocular glaucoma patients,              flow. Patients with very high presenting IOPs and those who
        and patients with split-fixation visual fields at risk for “wipe   did not show a significant response to medications do not
        out” syndrome. It is my experience that young African              seem to do as well in my experience.
        Americans also respond extremely well to canaloplasty
        because one does not have to be concerned with aggressive              Dr. Barnebey: The following three groups of patients may
        scarring in this patient population, due to the fact that there    benefit from canaloplasty over traditional trabeculectomy:
        is no bleb to maintain. Moreover, I am performing much             (1) patients in whom trabeculectomy is expected to fail,
        less cataract surgery combined with endocyclophotocoagu-           (2) patients who have a potential threat of additional irre-
        lation due to the superb results I am achieving with phaco-        versible loss of vision, and (3) patients whose jobs and/or
        canaloplasty.                                                      lifestyle makes them unable to tolerate the postoperative
                                                                           period of incapacity that often occurs after trabeculectomy.
           Dr. Vold: Canaloplasty has definitely made me more
        comfortable intervening surgically in my glaucoma patients.        Given its better safety profile over current incisional
        This procedure is an excellent surgical option for patients        glaucoma procedures,2 do you perform canaloplas-
        with uncontrolled mild-to-moderate open-angle glaucoma             ty on glaucoma patients earlier in the disease
        (OAG). Canaloplasty should also be strongly considered in          process?
        patients with more advanced OAG who are poor candi-                   Dr. Richardson: Absolutely! I now offer canaloplasty to
        dates for filtration surgery. Phacocanaloplasty is an out-         all of my patients scheduled for cataract surgery who use
        standing option for patients with controlled OAG and visu-         drops to control their glaucoma. Similarly to how I at least
        ally significant cataracts.                                        discuss the option of advanced IOLs with all of my cataract
                                                                           patients (who are candidates for such IOLs), I now feel that
        What type of glaucoma patients benefit the most                    all of my combined cataract and glaucoma patients deserve
        from canaloplasty?                                                 to be informed about the option of canaloplasty at the
           Dr. Richardson: OAG patients with mild-to-moderate              time of cataract surgery. I am also now comfortable offering
        glaucoma that is progressing on topical treatment or who           canaloplasty to patients who may only be on one or two
        are having difficulty tolerating medical treatment benefit         topical medications but are poorly tolerating medical thera-
        most from canaloplasty. It is worth mentioning that, when          py. The procedure is also a good choice for patients who
        we use the acronym “MTMT,” we should be honest and                 have issues with medication and follow-up compliance.
        admit that what this should stand for is minimally tolerated
        medical therapy. It may actually mean maximum medical                Dr. Morgan: As I become more comfortable with the

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      Canaloplasty: The Keys to Optimizing Patients’ Outcomes


        procedure, I offer it earlier in the disease process. That is not
        to say I offer it casually. It still is an operation, and it            “We now have a relatively safe surgical
        demands careful consideration. However, I am very com-                  option that can address the very source
        fortable offering it to patients to whom I was reluctant to
        offer traditional glaucoma surgery in the past. Canaloplasty
                                                                                 of our glaucoma patients' suffering.”
        really shines in cataract and glaucoma patients who wish to                             —David Richardson, MD
        reduce their dependence on medications.
                                                                            gery should be discussed with patients who have severe
          Dr. Barnebey: I have evolved to a position where a                glaucoma or who require especially low postoperative IOPs.
        canaloplasty is my initial procedure of choice unless there
        are circumstances that dictate otherwise.                           On rare occasions, surgeons may be unable to
                                                                            catheterize Schlemm canal for 360º due to scarring
           Dr. Sarkisian: Canaloplasty allows me to provide surgery         within the canal.What recommendations do you
        to patients who previously would have received only topical         have for the intraoperative management of these
        medication or laser trabeculoplasty. I feel that canaloplasty       cases?
        represents a significant advance in glaucoma surgery by                Dr. Richardson: It has been mentioned that some sur-
        allowing me to treat the earlier phases of glaucoma more            geons are reluctant to perform canaloplasty on patients ear-
        aggressively and more definitively.                                 lier in the disease process due to the concern that, if they
                                                                            cannot catheterize 360° of the canal, they will have to con-
           Dr. Vold: Without question, the impressive safety profile        vert to a trabeculectomy. These surgeons have been misin-
        of canaloplasty makes me more comfortable proceeding                formed. In my experience, if a patient has early glaucoma
        with glaucoma surgery in my glaucoma patients. Now that I           and the surgeon cannot achieve 360° of catheterization,
        have nearly 4 years of canaloplasty follow-up on some of my         there is still the option of a viscocanalostomy that (when
        patients, I am convinced that the procedure’s efficacy per-         combined with the more extensive viscodilation possible
        sists over time in most patients.                                   with the iTrack microcatheter) can be nearly as effective as
                                                                            canaloplasty. For a patient with early glaucoma, visco-
        How do you differentiate which patients are candi-                  canalostomy is an appropriate primary surgery in countries
        dates for canaloplasty from those who might be                      outside the United States. As such, it makes a fine “fall back”
        better served by standard filtration or tube shunt                  surgery when catheterization cannot be completed. Most of
        surgery?                                                            my patients who required a conversion to viscocanalostomy
          Dr. Richardson: Younger patients, high myopes, and                (modified by the more extensive viscodilation possible with
        African American patients tend to be better candidates for          the iTrack microcatheter) have done very well and are with-
        canaloplasty (as opposed to trabeculectomy).                        in a few IOP points of their fellow canaloplasty eye). After
                                                                            more than 100 canaloplasty cases, I have yet to convert a
           Dr. Sarkisian: Due to the 3-year canaloplasty data and my        single canaloplasty procedure to a trabeculectomy.
        own experience,2 I am becoming more comfortable offering
        canaloplasty to the vast majority of my OAG patients                   Dr. Barnebey: If a patient needs glaucoma surgery, most
        requiring surgical intervention. In patients with more              surgeons would select a trabeculectomy. If you are planning
        advanced glaucoma (except monocular patients or those               on performing canaloplasty and a problem develops, always
        with split fixation as mentioned above), or those with OAG,         have two or three backup strategies. For example, if I am
        neovascular glaucoma, iridocorneal endothelial syndrome,            unable to completely circumnavigate Schlemm canal for
        uveitic glaucoma, or other refractory glaucomas, I generally        360°, I will perform viscodilation from both directions and
        perform filtration surgery using the Ex-Press Glaucoma              convert to a deep sclerectomy procedure or place an
        Filtration Device. In patients with scarred conjunctiva, in         intrascleral collagen implant.
        which a filter would be less successful, I typically perform a
        conventional tube shunt.                                               Dr. Sarkisian: Most of the time, if I have an occlusion in
                                                                            the canal, I do not convert to a trabeculectomy. I simply use
           Dr. Vold: Canaloplasty results are best in patients with         the catheter to viscodilate as much of the canal as I can, and
        more mild-to-moderate OAG. However, canaloplasty can                then I close the flap, which is an excellent alternative dealing
        certainly be effective in more advanced glaucomatous dis-           with an occlusion. Performing a trabeculotomy may be
        ease. Unfortunately, histological studies show that the col-        another option if I can cannulate enough of the canal to do
        lector channel system has more scarring in patients who             a cut down and then a purse-string trabeculotomy using
        have been treated with long-term topical glaucoma medica-           the catheter. Finally, I may convert to a trabeculectomy if
        tion or who have end-stage disease.2 Standard filtration sur-       needed.

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                                                            Canaloplasty: The Keys to Optimizing Patients’ Outcomes


                      ADOPTING CANALOPLASTY: A NEW CANALOPLASTY SURGEON’S PERSPECTIVE

             Shannon Smith, MD, FACS, a glau-          She open-mindedly identified candi-          repetitively integrated the procedure
          coma subspecialist and cataract sur-         dates as having open-angle glaucoma          and gained the skills and confidence
          geon practicing in Nacogdoches,              or ocular hypertension with a high risk      to add canaloplasty to her surgical
          Texas, recently began the process of         of progression and without specific          repertoire.
          adding canaloplasty to her surgical          contraindications, ie, angle abnormali-         Dr. Smith now considers canaloplas-
          armamentarium. After performing              ties, peripheral anterior synechiae,         ty a viable first surgical option for her
          trabeculectomy and tube shunt sur-           prior surgical interruption of the canal,    patients with open-angle glaucoma.
          gery for 2 decades, she became con-          etc. She performed 25 canaloplasties         She is enthusiastic about its potential
          vinced that canaloplasty offers signif-      within 3 months, shortening and              long-term success rate and limited
          icant advantages over traditional            enhancing her learning curve by              risk, which will benefit patients’ and
          penetrating surgery. Three-year              scheduling multiple consecutive pro-         surgeons’ quality of life.
          prospective efficacy and safety data         cedures on each surgery day.
          from highly respected colleagues                She acknowledged that despite the            Shannon Smith, MD, FACS, has no
          finally encouraged her to begin the          initial intimidation of deep dissection      financial interest in the company men-
          process of adopting canaloplasty as a        to the traditionally unfamiliar anato-       tioned herein. She may be reached at
          surgical option for her patients with        my of Schlemm Canal, as well as an           info@eyesoftexas.us.
          glaucoma.1                                   incidence of very early postoperative
             Dr. Smith was fully committed to          hyphema, blurred vision, and short-          1. Lewis R, Von Wolff K, Tetz M, et al. Three-year results of
                                                                                                    circumferential viscodilation and tensioning of Schlemm
          pushing through the canaloplasty             term hypotony with inadvertent pen-          canal using a microcatheter to treat open-angle glaucoma.
          learning process in a timely fashion.        etration, she has aggressively and           J Cataract Refract Surg. 2011;37(4):682-690.




           Dr. Vold: In cases of advanced glaucoma, I tend to con-                Dr. Vold: Most patients have no idea how much blebs
        vert to trabeculectomy. For more mild glaucomatous dis-               can affect the quality of their lives postoperatively. I think it
        ease, viscocanalostomy is certainly a viable surgical alterna-        is important for us to educate our patients in this regard. I
        tive. Fortunately, the need to make this type of decision is          highlight the benefits of canaloplasty such as a faster post-
        rare. I encourage surgeons to have thought through their              operative recovery of vision, reduced perioperative compli-
        plan of attack prior to initiating surgery.                           cations, and fewer postoperative visits when compared with
                                                                              trabeculectomy.2 Patients who have undergone canaloplas-
        Canaloplasty surgeons are generally excited to talk                   ty commonly have a better overall quality of vision than
        about bleb-free surgery with their patients. Do you                   patients with filtration blebs.2 This is due to fewer ocular dis-
        include this discussion in your consultations?                        ease problems, less induced astigmatism, and the elimina-
           Dr. Richardson: Absolutely! This is the defining benefit of        tion of fluctuating vision due to postoperative hypotony.2
        canaloplasty. Yes, it is nice that the IOP reduction is on par
        with trabeculectomy and tubes, but if canaloplasty required a         What advice would you give to a new surgeon recruit-
        bleb, it would still be a “me too” surgery offering little in terms   ing patients for his or her first canaloplasty cases?
        of what patients are looking for, which is to make their lives           Dr. Richardson: I think the ideal patient for a new surgeon
        easier while protecting their vision.4 Patients hate their drops,     to perform canaloplasty on is either (1) a patient with mild-
        and most of my patients hate their blebs after trabeculecto-          to-moderate glaucoma that is progressing who has side
        my. Blebs are irritating and limiting (in terms of the activities     effects from topical medical therapy (such as symptomatic
        of daily living). Additionally, the reason canaloplasty can be        ocular surface disease) or (2) a patient with a cataract and
        offered earlier in the course of glaucoma is that it has far fewer    glaucoma on medical therapy who has chosen a standard
        risks than either trabeculectomy or tube shunt surgery.2              IOL. In the latter case, since the patient is expecting to wear
                                                                              glasses (or at least should be if the surgeon has properly man-
          Dr. Barnebey: I do discuss canaloplasty, but I am cautious          aged his or her expectations), there will be time for the eye to
        not to guarantee the absence of a bleb, because one can               properly heal from the combined surgeries before the pre-
        occur in a small group of patients.2                                  scription of new glasses. I would advise against performing
                                                                              phacocanaloplasty on patients with either a multifocal or
           Dr. Sarkisian: The prevention of bleb formation is clearly a       toric IOL, although this could be done in a staged manner by
        significant advantage of this procedure. As surgeons, we              performing canaloplasty first, followed by cataract surgery
        have a responsibility to inform our patients of the clinical          with the implantation of an advanced IOL once any induced
        implications of long-term blebs.                                      corneal astigmatism has stabilized.

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      Canaloplasty: The Keys to Optimizing Patients’ Outcomes



           Dr. Morgan: Focus discussion on the safety of the proce-                    “Patients who have undergone
        dure compared with blebs. Remove the pressure from your-                   canaloplasty commonly have a better
        self and offer the procedure to phacoemulsification patients               overall quality of vision than patients
        on two or more glaucoma medications. This way, if you do                     with filtration blebs.2 This is due to
        not succeed, the operation will still be a success. Patients                 fewer ocular disease problems, less
        burdened by the cost of topical medications or who have
        medicamentosa are also superb candidates for canaloplasty.                      induced astigmatism, and the
        These patients will be especially grateful.                                 elimination of fluctuating vision due
           Dr. Barnebey: I look at patients who have a deep angle                        to postoperative hypotony ”
        and no previous glaucoma surgery. I also consider those                                           —Steven Vold, MD
        who have significant ocular surface disease or blepharitis
        where there is an increased risk of bleb-related challenges.
                                                                         complaints and “continuing present management.” I have
          Dr. Sarkisian: Select patients with deep anterior cham-        never had a trabeculectomy patient thank me for recom-
        bers. Younger patients with mild-to-moderate glaucoma            mending surgery. On the other hand, I now have multiple
        and pseudophakes are excellent first cases. Inform the           canaloplasty patients who give me a hug every time I see
        patient that you might need to do a trabeculectomy so that       them. That is a difference you will not see in the published
        they are psychologically prepared for that possibility.          literature but should.

           Dr. Vold: Combined procedures are a great place to start.        Canaloplasty is an excellent alternative to standard filtra-
        In early cases, I recommend surgeons follow what I call the      tion surgery in the vast majority of OAG patients. Prospective
        “5-minute rule” when attempting to cannulate Schlemm             studies demonstrate IOP outcomes comparable to those associ-
        canal. If a surgeon spends more than 5 minutes on it, I have     ated with trabeculectomy.2 Skilled anterior segment surgeons
        found the prognosis for the surgical outcome generally to        can successfully adopt canaloplasty in a timely fashion. With
        be more guarded. Failure to cannulate Schlemm canal, how-        the appropriate selection of patients and proper surgical plan-
        ever, does not necessarily mean surgical failure.                ning, surgeons should be encouraged by their early results with
                                                                         canaloplasty. More importantly, patients’ surgical care and
        What advice would you give to surgeons who say                   quality of life should be significantly enhanced. For these rea-
        they are struggling to find patients for their first             sons, the use of canaloplasty continues to grow among both
        canaloplasty cases?                                              glaucomatologists and comprehensive ophthalmologists in the
           Dr. Richardson: Open your eyes and ears. What I mean          United States. Ultimately, patients will be the primary benefac-
        by that is take a look at what the topical glaucoma treat-       tors of this significant change in the glaucoma treatment para-
        ments are doing to your patients’ corneal surfaces and con-      digm.
        junctivae. Refractive surgeons have learned the value of a
                                                                          1. Heijl A, Bengtsson B, Hyman L, et al. Natural history of open-angle glaucoma.
        smooth corneal surface in relation to quality of vision. If,     Ophthalmology. 2009;116(12)2271-2276.
        after all, our primary goal is to optimize our glaucoma          2. Lewis R, Von Wolff K, Tetz M, et al. Three-year results of circumferential viscodilation and ten-
                                                                         sioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J Cataract Refract
        patients’ vision (and not just preserve vision limited by a      Surg. 2011;37(4):682-690.
        beat-up corneal surface), then the exacerbation of ocular        3. Gedde SJ, Schiffman JC, Feuer WJ, et al. Three-year follow-up of the tube versus trabeculec-
                                                                         tomy study. Am J Ophthalmol. 2009;148(5):670-684.
        surface disease by topical medical therapy needs to be rec-      4. Tam D, Calafati J, Ahmed I. Non-penetrating Schlemm’s canaloplasty versus trabeculectomy.
        ognized and addressed. Also, listen to what your glaucoma        Paper presented at: The American Society of Cataract and Refractive Surgery Annual Meeting;
                                                                         April 6, 2009; San Francisco, CA.
        patients are saying. What do they complain about the
        most? I will bet you dollars to donuts it is related to (or
        exacerbated by) the use of their glaucoma drops. Every time
        a glaucoma patient on topical therapy complains about the
        cost of his or her drops, the difficulty he or she has remem-
        bering to use them (alongside his or her dozen or so other
        medications), tearing, transient blurring, hyperemia, sore
        eyes, etc., he or she is pleading with you both to listen and
        to solve the cause of his or her suffering. We now have a rel-
        atively safe surgical option that can address the very source
        of our glaucoma patients’ suffering. I think we owe it to
        them to at least consider the possibility that they would be
        better served by canaloplasty than by our ignoring their

       8 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I NOVEMBER 2011

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Canaloplasty The Keys to Optimizing Patients' Outcomes

  • 1. gt1011_iscience.qxd 10/6/11 4:42 PM Page 1 Canaloplasty: November 2011 Sponsored by iScience Interventional The Keys to Optimizing Patients’ Outcomes Supplement to
  • 2. gt1011_iscience.qxd 10/6/11 4:42 PM Page 2 Canaloplasty: The Keys to Optimizing Patients’ Outcomes Canaloplasty: The Keys to Optimizing Patients’ Outcomes T he introduction of canaloplasty into PANEL the glaucoma surgical armamentarium was motivated by the desire of clini- Steven D. Vold, MD, (moderator) is in private practice cians to enhance the quality of with Vold Vision in Bentonville, Arkansas. He is a consult- patients’ glaucoma care. Patients’ long-term ant to and clinical investigator for iScience Interventional. adherence to topical glaucoma medical therapy Dr. Vold may be reached at (479) 246-1700; is well known to be relatively poor. Laser thera- svold@cox.net. py offers a safe alternative to medical therapy Howard Barnebey, MD, is medical director and CEO of but often still requires the addition of topical Specialty Eyecare Centres in Seattle. He is medical medication. Traditionally, glaucoma filtration advisor for iScience Interventional. Dr. Barnebey may surgery has been reserved for more advanced, be reached at (206) 621-8407; uncontrolled glaucoma for obvious reasons. hbarnebey@specialtyeyecarecentre.com. Despite its definite role in glaucoma care, patients undergoing standard trabeculectomy Michael Morgan, MD, is the chairman of the are at significant risk for the development of Department of Ophthalmology at Ochsner Clinic postoperative infection, cataract, hypotony, bleb Foundation in Baton Rouge, Louisiana, and an associate dysesthesia, astigmatism, and decreased visual faculty member of the Louisiana State University Medical acuity. These potential complications have driv- Science Center’s Department of Ophthalmology. He en surgeons to pursue surgical alternatives. acknowledged no financial interest in the products or companies Canaloplasty is a well-established procedure mentioned herein. Dr. Morgan may be reached at (225) 761-5400; that has, for the past 3 years, demonstrated mimorgan@ochsner.org. impressive efficacy and safety in peer-reviewed David Richardson, MD, is the medical director of San prospective studies. Despite growing evidence of Gabriel Valley Eye Associates, Inc., in San Gabriel, its value and increasing performance of the pro- California. He is a consultant to iScience Interventional. cedure by ophthalmologists all over the world, Dr. Richardson may be reached at (626) 289-7856; misconceptions regarding its long-term efficacy david.richardson@sangabrieleye.com. as well as challenges in its adoption, surgical technique, and patient selection persist. Several Steven R. Sarkisian Jr, MD, is the director of the glaucoma experienced and leading surgeons share their fellowship at The Dean A. McGee Eye Institute and a experiences and pearls for optimizing success clinical associate professor of ophthalmology at the with canaloplasty. University of Oklahoma in Oklahoma City. He is a con- sultant to and clinical investigator for iScience — Steven D. Vold, MD Interventional. Dr. Sarkisian may be reached at (405) 271- 1093; steven-sarkisian@dmei.org. 2 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I NOVEMBER 2011
  • 3. gt1011_iscience.qxd 10/6/11 4:42 PM Page 3 Canaloplasty: The Keys to Optimizing Patients’ Outcomes Please briefly describe your early experience with “Any procedure can be challenging, but and approach to adopting canaloplasty. Dr. Richardson: I was comfortable with the basic ele- the learning curve for a surgeon who is ments of the procedure after performing about a 1/2 dozen well versed in trabeculectomy and who cases. As with any surgery, however, there are skills that can- understands the anatomy of the not be mastered until the steps become nearly habitual. anterior segment of the eye is easier Essential to the development of any habit or skill is repeti- than the learning curve for tion within a short time frame. A key reason I became com- phacoemulsification.” fortable with canaloplasty early on is I grouped my first dozen cases over just a few months so I did not have to —Howard Barnebey, MD “relearn” the procedure with each scheduled canaloplasty. Also worth mentioning is the clinical education offered by was already familiar with the canalicular anatomy. However, iScience is unprecedented in terms of the wet lab prepara- with the exception of the deep sclerectomy, most of the tion, in-surgery and in-person support, and the postopera- steps in performing canaloplasty are familiar to any surgeon tive telephone support. Support from iScience gets you who has done a trabeculectomy. past the initially steep learning curve. After that, it is easy to discuss cases with multiple canaloplasty surgeons around Some surgeons have suggested that the learning the United States who are all eager to share their experi- curve for canaloplasty can be challenging.Would ences. Once you master canaloplasty, you tend to get excit- you agree or disagree with this statement? ed about sharing this procedure, so the support from more Dr. Richardson: The steps involved in canaloplasty are experienced surgeons is always readily available. new for most surgeons, so of course, there is going to be a learning curve. Does that learning curve compare to the ini- Dr. Morgan: In order to successfully adopt canaloplasty, I tial curve required to become competent at phacoemulsifi- studied the principles of deep sclerectomy very intensely by cation? It is not even close. Like phacoemulsification, watching videos and strictly adhering to the following canaloplasty requires finesse and an understanding of the guidelines: local anatomy, but there are fewer steps involved (as well as • Find the correct depth at the apex of the deep dissec- fewer points during which you can get yourself into trou- tion by cutting right down to the ciliary body. You can do ble). Any cataract surgeon who no longer gets nervous this safely by slowly working your way down with the super- making a capsulorhexis or who regularly polishes the cap- sharp blade until the ciliary body is encountered. sule can master canaloplasty. Handling Descemet mem- • Once the correct depth has been found, back up a few brane is not so different from dealing with the capsule. That fibers and advance. This is the correct plane to access said, I would not recommend canaloplasty to an inexperi- Schlemm canal. enced surgeon who is not yet comfortable touching the • Stay in the same plane, especially when you approach bare capsule with an instrument. the scleral spur. Avoid the temptation to hasten the process by deepening the plane when you get close to the spur. Dr. Morgan: It is important for the prospective surgeon to realize that the barriers to adoption are largely mental. Dr. Barnebey: Like with most new procedures, my learn- Most accomplished phaco surgeons already possess the ing curve did not occur overnight or in a single step. I skills necessary to perform the procedure. The techniques learned the fundamentals of performing a good trabeculec- are not more difficult than complex, small-pupil pha- tomy during my fellowship. In the early 1990s, a variation on coemulsification, but because the required surgical maneu- the trabeculectomy was introduced as a deep sclerectomy vers are new to the surgeon, they are intimidating. This can and later as a viscocanalostomy. I honed my skills doing make surgeons afraid to try the procedure. If they begin these procedures and had respectable results. The introduc- with the right patient population, the stress can be greatly tion of canaloplasty was another building block. minimized. Scientifically, the introduction of a catheter with 360° vis- codilation and placement of a retaining stent was a dramat- Dr. Barnebey: Any procedure can be challenging, but the ic step in the advancement of the surgery. The addition of learning curve for a surgeon who is well versed in tra- the microcatheter and stent was an incremental additional beculectomy and who understands the anatomy of the step with a relatively brief learning curve. anterior segment of the eye is easier than the learning curve Dr. Sarkisian: I personally started the canaloplasty adop- for phacoemulsification. tion process rather slowly. After 10 to 15 cases, I began developing confidence in the procedure. I had been per- Dr. Sarkisian: The learning curve is challenging but not forming trabeculotomies on children for some time, so I insurmountable. Trabeculectomy provides the basic skill set NOVEMBER 2011 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I 3
  • 4. gt1011_iscience.qxd 10/6/11 4:42 PM Page 4 Canaloplasty: The Keys to Optimizing Patients’ Outcomes for performing canaloplasty. The main new things are isolat- ing Schlemm canal and fashioning the trabeculo-Descemet “Canaloplasty allows me to provide window. surgery to patients who previously would have received only topical Dr. Vold: From my perspective, the challenges associated medication or laser trabeculoplasty. I with canaloplasty are overstated. Experienced surgeons should have little difficulty adopting this procedure. The feel that canaloplasty represents a keys to successfully adopting canaloplasty are being knowl- significant advance in glaucoma edgeable of the angle anatomy and having the ability to surgery by allowing me to treat the fashion quality scleral dissections. Threading the iTrack earlier phases of glaucoma more microcatheter (iScience Interventional, Menlo Park, CA) is aggressively and more definitively.” relatively easy once Schlemm canal has been isolated. Without question, quality anterior segment surgeons —Steven R. Sarkisian Jr, MD should have little difficulty successfully performing canalo- plasty. aged by your improved results to press on and perform more cases. You then begin to get more aggressive in find- What advice would you give to your colleagues to ing patients who are good candidates earlier in their treat- make the learning process easier? ment algorithm. Dr. Richardson: Familiarize yourself with the steps involved in canaloplasty. Read the materials provided by Before you started offering canaloplasty to your iScience. Do a search on YouTube and watch some of the patients, what was your greatest concern about per- videos. Then, memorize the steps and mentally perform forming this procedure? the surgery before your first case. Many experienced sur- Dr. Richardson: I had two main concerns. First, would I geons forget that they must prepare and practice mentally if be able to do it? Dissecting the trabeculo-Descemet win- they are going to succeed physically. Surgeons are no differ- dow sounds nearly impossible to someone who has never ent (or better) than athletes in this manner. Show me a golf done such a thing. Funny, that is probably what I would professional who has not at least “walked” the course prior have thought about polishing the posterior capsule years to the tournament, and I will show you someone who has ago (something I routinely do now). Second, will I harm my no chance of winning the purse. patient? I quickly learned that canaloplasty is a very forgiv- ing surgery. It is as near to a “no harm, no foul” glaucoma Dr. Morgan: The key to reducing the initial stress is in surgery as I have ever experienced. Is it totally without risk? choosing the right patients for your early cases. I strongly Of course not, but compared to the bleb-dependent glau- recommend choosing patients who are undergoing a coma surgeries, it is in a league of its own. cataract procedure at the same time and do not desperately need an extremely low IOP. The typical cataract and glauco- Dr. Morgan: I had to come to terms with the fact that I ma patient on two or more medications is the ideal patient might not succeed. Ophthalmologists are generally very to start on. If the procedure is not successful, the patient will accomplished individuals. They are not comfortable with still be happy with the results of the cataract surgery. On the the prospect of failure. Once I accepted that I might not other hand, a successful canaloplasty procedure will reduce succeed, I was ready to move forward. It is helpful to have a his or her dependence on medications, which will further comfortable backup plan in your mind, such as implanting enhance the outcome. an Ex-Press Glaucoma Filtration Device (Alcon Laboratories, Inc., Fort Worth, TX) or performing trabeculectomy. Dr. Barnebey: Deliberate, focused study and practice are necessary. Break the procedure into manageable steps and Dr. Sarkisian: My early concern was making a good tra- focus on understanding and mastering each of those steps beculo-Descemet window, but the new canaloplasty instru- based on your individual skill set and experience. It is also mentation by Mastel Precision, Inc., (Rapid City, SD) makes important to latch onto a mentor who can help guide you performing this part of the procedure much easier for sur- through the process. geons who are new to canaloplasty. Dr. Sarkisian: You have to jump in with both feet. Get How has canaloplasty influenced your treatment past the learning curve in the first 2 months. It generally paradigm for glaucoma patients? takes 10 to 15 cases. The more canaloplasty cases you per- Dr. Richardson: I now move directly from maximum tol- form, the better you get. Just like when learning phaco for erated medical therapy to canaloplasty without bothering the first time, you soon get more confident and are encour- with laser trabeculoplasty. 4 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I NOVEMBER 2011
  • 5. gt1011_iscience.qxd 10/6/11 4:42 PM Page 5 Canaloplasty: The Keys to Optimizing Patients’ Outcomes Dr. Morgan: Canaloplasty has totally changed how I treat “The key to reducing the initial stress glaucoma patients. I now have a safe and effective glaucoma is in choosing the right patients for procedure that I can perform early in the disease process. your early cases. I strongly recommend We know from evidence-based glaucoma studies, such as choosing patients who are undergo- the Early Manifest Glaucoma Treatment Trial, that earlier intervention is better.1 The problem we have had to deal ing a cataract procedure at the same with is that we did not have a truly safe glaucoma proce- time and do not desperately need an dure. For this reason, we hesitated to treat patients whom extremely low IOP. ” we knew would be better off with a lower IOP. In the past, I —Michael Morgan, MD intervened surgically only when absolutely necessary. Now, I can confidentially treat patients much sooner, and this allows me to provide superior care. therapy, but I have yet to see a patient on two to three dif- ferent drops who is really “tolerating” the treatment well. Dr. Barnebey: It is always wonderful to have choices, since Between ocular surface issues, systemic side effects, and the there is no single procedure that is appropriate for all glau- cost of treatment, most patients on more than one or two coma patients. Canaloplasty provides a minimally invasive separate drops really need a better alternative therapy. strategy by which to re-establish aqueous outflow with minimal-to-no violation of the anterior chamber; good, sus- Dr. Morgan: Canaloplasty has been most effective for me tained IOP-lowering efficacy; a safer complication profile; in patients who present with moderately elevated IOPs of and the prospect of avoiding the long-term challenges of a around 35 mm Hg without medication. Also, it appears that conjunctival bleb.2,3 patients who respond to medications initially, but not enough to eliminate their risk of vision loss, are the best can- Dr. Sarkisian: Canaloplasty is now my procedure of didates. These patients, I reason, have some trabecular out- choice for baby boomers, monocular glaucoma patients, flow. Patients with very high presenting IOPs and those who and patients with split-fixation visual fields at risk for “wipe did not show a significant response to medications do not out” syndrome. It is my experience that young African seem to do as well in my experience. Americans also respond extremely well to canaloplasty because one does not have to be concerned with aggressive Dr. Barnebey: The following three groups of patients may scarring in this patient population, due to the fact that there benefit from canaloplasty over traditional trabeculectomy: is no bleb to maintain. Moreover, I am performing much (1) patients in whom trabeculectomy is expected to fail, less cataract surgery combined with endocyclophotocoagu- (2) patients who have a potential threat of additional irre- lation due to the superb results I am achieving with phaco- versible loss of vision, and (3) patients whose jobs and/or canaloplasty. lifestyle makes them unable to tolerate the postoperative period of incapacity that often occurs after trabeculectomy. Dr. Vold: Canaloplasty has definitely made me more comfortable intervening surgically in my glaucoma patients. Given its better safety profile over current incisional This procedure is an excellent surgical option for patients glaucoma procedures,2 do you perform canaloplas- with uncontrolled mild-to-moderate open-angle glaucoma ty on glaucoma patients earlier in the disease (OAG). Canaloplasty should also be strongly considered in process? patients with more advanced OAG who are poor candi- Dr. Richardson: Absolutely! I now offer canaloplasty to dates for filtration surgery. Phacocanaloplasty is an out- all of my patients scheduled for cataract surgery who use standing option for patients with controlled OAG and visu- drops to control their glaucoma. Similarly to how I at least ally significant cataracts. discuss the option of advanced IOLs with all of my cataract patients (who are candidates for such IOLs), I now feel that What type of glaucoma patients benefit the most all of my combined cataract and glaucoma patients deserve from canaloplasty? to be informed about the option of canaloplasty at the Dr. Richardson: OAG patients with mild-to-moderate time of cataract surgery. I am also now comfortable offering glaucoma that is progressing on topical treatment or who canaloplasty to patients who may only be on one or two are having difficulty tolerating medical treatment benefit topical medications but are poorly tolerating medical thera- most from canaloplasty. It is worth mentioning that, when py. The procedure is also a good choice for patients who we use the acronym “MTMT,” we should be honest and have issues with medication and follow-up compliance. admit that what this should stand for is minimally tolerated medical therapy. It may actually mean maximum medical Dr. Morgan: As I become more comfortable with the NOVEMBER 2011 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I 5
  • 6. gt1011_iscience.qxd 10/6/11 4:42 PM Page 6 Canaloplasty: The Keys to Optimizing Patients’ Outcomes procedure, I offer it earlier in the disease process. That is not to say I offer it casually. It still is an operation, and it “We now have a relatively safe surgical demands careful consideration. However, I am very com- option that can address the very source fortable offering it to patients to whom I was reluctant to offer traditional glaucoma surgery in the past. Canaloplasty of our glaucoma patients' suffering.” really shines in cataract and glaucoma patients who wish to —David Richardson, MD reduce their dependence on medications. gery should be discussed with patients who have severe Dr. Barnebey: I have evolved to a position where a glaucoma or who require especially low postoperative IOPs. canaloplasty is my initial procedure of choice unless there are circumstances that dictate otherwise. On rare occasions, surgeons may be unable to catheterize Schlemm canal for 360º due to scarring Dr. Sarkisian: Canaloplasty allows me to provide surgery within the canal.What recommendations do you to patients who previously would have received only topical have for the intraoperative management of these medication or laser trabeculoplasty. I feel that canaloplasty cases? represents a significant advance in glaucoma surgery by Dr. Richardson: It has been mentioned that some sur- allowing me to treat the earlier phases of glaucoma more geons are reluctant to perform canaloplasty on patients ear- aggressively and more definitively. lier in the disease process due to the concern that, if they cannot catheterize 360° of the canal, they will have to con- Dr. Vold: Without question, the impressive safety profile vert to a trabeculectomy. These surgeons have been misin- of canaloplasty makes me more comfortable proceeding formed. In my experience, if a patient has early glaucoma with glaucoma surgery in my glaucoma patients. Now that I and the surgeon cannot achieve 360° of catheterization, have nearly 4 years of canaloplasty follow-up on some of my there is still the option of a viscocanalostomy that (when patients, I am convinced that the procedure’s efficacy per- combined with the more extensive viscodilation possible sists over time in most patients. with the iTrack microcatheter) can be nearly as effective as canaloplasty. For a patient with early glaucoma, visco- How do you differentiate which patients are candi- canalostomy is an appropriate primary surgery in countries dates for canaloplasty from those who might be outside the United States. As such, it makes a fine “fall back” better served by standard filtration or tube shunt surgery when catheterization cannot be completed. Most of surgery? my patients who required a conversion to viscocanalostomy Dr. Richardson: Younger patients, high myopes, and (modified by the more extensive viscodilation possible with African American patients tend to be better candidates for the iTrack microcatheter) have done very well and are with- canaloplasty (as opposed to trabeculectomy). in a few IOP points of their fellow canaloplasty eye). After more than 100 canaloplasty cases, I have yet to convert a Dr. Sarkisian: Due to the 3-year canaloplasty data and my single canaloplasty procedure to a trabeculectomy. own experience,2 I am becoming more comfortable offering canaloplasty to the vast majority of my OAG patients Dr. Barnebey: If a patient needs glaucoma surgery, most requiring surgical intervention. In patients with more surgeons would select a trabeculectomy. If you are planning advanced glaucoma (except monocular patients or those on performing canaloplasty and a problem develops, always with split fixation as mentioned above), or those with OAG, have two or three backup strategies. For example, if I am neovascular glaucoma, iridocorneal endothelial syndrome, unable to completely circumnavigate Schlemm canal for uveitic glaucoma, or other refractory glaucomas, I generally 360°, I will perform viscodilation from both directions and perform filtration surgery using the Ex-Press Glaucoma convert to a deep sclerectomy procedure or place an Filtration Device. In patients with scarred conjunctiva, in intrascleral collagen implant. which a filter would be less successful, I typically perform a conventional tube shunt. Dr. Sarkisian: Most of the time, if I have an occlusion in the canal, I do not convert to a trabeculectomy. I simply use Dr. Vold: Canaloplasty results are best in patients with the catheter to viscodilate as much of the canal as I can, and more mild-to-moderate OAG. However, canaloplasty can then I close the flap, which is an excellent alternative dealing certainly be effective in more advanced glaucomatous dis- with an occlusion. Performing a trabeculotomy may be ease. Unfortunately, histological studies show that the col- another option if I can cannulate enough of the canal to do lector channel system has more scarring in patients who a cut down and then a purse-string trabeculotomy using have been treated with long-term topical glaucoma medica- the catheter. Finally, I may convert to a trabeculectomy if tion or who have end-stage disease.2 Standard filtration sur- needed. 6 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I NOVEMBER 2011
  • 7. gt1011_iscience.qxd 10/6/11 4:42 PM Page 7 Canaloplasty: The Keys to Optimizing Patients’ Outcomes ADOPTING CANALOPLASTY: A NEW CANALOPLASTY SURGEON’S PERSPECTIVE Shannon Smith, MD, FACS, a glau- She open-mindedly identified candi- repetitively integrated the procedure coma subspecialist and cataract sur- dates as having open-angle glaucoma and gained the skills and confidence geon practicing in Nacogdoches, or ocular hypertension with a high risk to add canaloplasty to her surgical Texas, recently began the process of of progression and without specific repertoire. adding canaloplasty to her surgical contraindications, ie, angle abnormali- Dr. Smith now considers canaloplas- armamentarium. After performing ties, peripheral anterior synechiae, ty a viable first surgical option for her trabeculectomy and tube shunt sur- prior surgical interruption of the canal, patients with open-angle glaucoma. gery for 2 decades, she became con- etc. She performed 25 canaloplasties She is enthusiastic about its potential vinced that canaloplasty offers signif- within 3 months, shortening and long-term success rate and limited icant advantages over traditional enhancing her learning curve by risk, which will benefit patients’ and penetrating surgery. Three-year scheduling multiple consecutive pro- surgeons’ quality of life. prospective efficacy and safety data cedures on each surgery day. from highly respected colleagues She acknowledged that despite the Shannon Smith, MD, FACS, has no finally encouraged her to begin the initial intimidation of deep dissection financial interest in the company men- process of adopting canaloplasty as a to the traditionally unfamiliar anato- tioned herein. She may be reached at surgical option for her patients with my of Schlemm Canal, as well as an info@eyesoftexas.us. glaucoma.1 incidence of very early postoperative Dr. Smith was fully committed to hyphema, blurred vision, and short- 1. Lewis R, Von Wolff K, Tetz M, et al. Three-year results of circumferential viscodilation and tensioning of Schlemm pushing through the canaloplasty term hypotony with inadvertent pen- canal using a microcatheter to treat open-angle glaucoma. learning process in a timely fashion. etration, she has aggressively and J Cataract Refract Surg. 2011;37(4):682-690. Dr. Vold: In cases of advanced glaucoma, I tend to con- Dr. Vold: Most patients have no idea how much blebs vert to trabeculectomy. For more mild glaucomatous dis- can affect the quality of their lives postoperatively. I think it ease, viscocanalostomy is certainly a viable surgical alterna- is important for us to educate our patients in this regard. I tive. Fortunately, the need to make this type of decision is highlight the benefits of canaloplasty such as a faster post- rare. I encourage surgeons to have thought through their operative recovery of vision, reduced perioperative compli- plan of attack prior to initiating surgery. cations, and fewer postoperative visits when compared with trabeculectomy.2 Patients who have undergone canaloplas- Canaloplasty surgeons are generally excited to talk ty commonly have a better overall quality of vision than about bleb-free surgery with their patients. Do you patients with filtration blebs.2 This is due to fewer ocular dis- include this discussion in your consultations? ease problems, less induced astigmatism, and the elimina- Dr. Richardson: Absolutely! This is the defining benefit of tion of fluctuating vision due to postoperative hypotony.2 canaloplasty. Yes, it is nice that the IOP reduction is on par with trabeculectomy and tubes, but if canaloplasty required a What advice would you give to a new surgeon recruit- bleb, it would still be a “me too” surgery offering little in terms ing patients for his or her first canaloplasty cases? of what patients are looking for, which is to make their lives Dr. Richardson: I think the ideal patient for a new surgeon easier while protecting their vision.4 Patients hate their drops, to perform canaloplasty on is either (1) a patient with mild- and most of my patients hate their blebs after trabeculecto- to-moderate glaucoma that is progressing who has side my. Blebs are irritating and limiting (in terms of the activities effects from topical medical therapy (such as symptomatic of daily living). Additionally, the reason canaloplasty can be ocular surface disease) or (2) a patient with a cataract and offered earlier in the course of glaucoma is that it has far fewer glaucoma on medical therapy who has chosen a standard risks than either trabeculectomy or tube shunt surgery.2 IOL. In the latter case, since the patient is expecting to wear glasses (or at least should be if the surgeon has properly man- Dr. Barnebey: I do discuss canaloplasty, but I am cautious aged his or her expectations), there will be time for the eye to not to guarantee the absence of a bleb, because one can properly heal from the combined surgeries before the pre- occur in a small group of patients.2 scription of new glasses. I would advise against performing phacocanaloplasty on patients with either a multifocal or Dr. Sarkisian: The prevention of bleb formation is clearly a toric IOL, although this could be done in a staged manner by significant advantage of this procedure. As surgeons, we performing canaloplasty first, followed by cataract surgery have a responsibility to inform our patients of the clinical with the implantation of an advanced IOL once any induced implications of long-term blebs. corneal astigmatism has stabilized. NOVEMBER 2011 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I 7
  • 8. gt1011_iscience.qxd 10/6/11 4:42 PM Page 8 Canaloplasty: The Keys to Optimizing Patients’ Outcomes Dr. Morgan: Focus discussion on the safety of the proce- “Patients who have undergone dure compared with blebs. Remove the pressure from your- canaloplasty commonly have a better self and offer the procedure to phacoemulsification patients overall quality of vision than patients on two or more glaucoma medications. This way, if you do with filtration blebs.2 This is due to not succeed, the operation will still be a success. Patients fewer ocular disease problems, less burdened by the cost of topical medications or who have medicamentosa are also superb candidates for canaloplasty. induced astigmatism, and the These patients will be especially grateful. elimination of fluctuating vision due Dr. Barnebey: I look at patients who have a deep angle to postoperative hypotony ” and no previous glaucoma surgery. I also consider those —Steven Vold, MD who have significant ocular surface disease or blepharitis where there is an increased risk of bleb-related challenges. complaints and “continuing present management.” I have Dr. Sarkisian: Select patients with deep anterior cham- never had a trabeculectomy patient thank me for recom- bers. Younger patients with mild-to-moderate glaucoma mending surgery. On the other hand, I now have multiple and pseudophakes are excellent first cases. Inform the canaloplasty patients who give me a hug every time I see patient that you might need to do a trabeculectomy so that them. That is a difference you will not see in the published they are psychologically prepared for that possibility. literature but should. Dr. Vold: Combined procedures are a great place to start. Canaloplasty is an excellent alternative to standard filtra- In early cases, I recommend surgeons follow what I call the tion surgery in the vast majority of OAG patients. Prospective “5-minute rule” when attempting to cannulate Schlemm studies demonstrate IOP outcomes comparable to those associ- canal. If a surgeon spends more than 5 minutes on it, I have ated with trabeculectomy.2 Skilled anterior segment surgeons found the prognosis for the surgical outcome generally to can successfully adopt canaloplasty in a timely fashion. With be more guarded. Failure to cannulate Schlemm canal, how- the appropriate selection of patients and proper surgical plan- ever, does not necessarily mean surgical failure. ning, surgeons should be encouraged by their early results with canaloplasty. More importantly, patients’ surgical care and What advice would you give to surgeons who say quality of life should be significantly enhanced. For these rea- they are struggling to find patients for their first sons, the use of canaloplasty continues to grow among both canaloplasty cases? glaucomatologists and comprehensive ophthalmologists in the Dr. Richardson: Open your eyes and ears. What I mean United States. Ultimately, patients will be the primary benefac- by that is take a look at what the topical glaucoma treat- tors of this significant change in the glaucoma treatment para- ments are doing to your patients’ corneal surfaces and con- digm. junctivae. Refractive surgeons have learned the value of a 1. Heijl A, Bengtsson B, Hyman L, et al. Natural history of open-angle glaucoma. smooth corneal surface in relation to quality of vision. If, Ophthalmology. 2009;116(12)2271-2276. after all, our primary goal is to optimize our glaucoma 2. Lewis R, Von Wolff K, Tetz M, et al. Three-year results of circumferential viscodilation and ten- sioning of Schlemm canal using a microcatheter to treat open-angle glaucoma. J Cataract Refract patients’ vision (and not just preserve vision limited by a Surg. 2011;37(4):682-690. beat-up corneal surface), then the exacerbation of ocular 3. Gedde SJ, Schiffman JC, Feuer WJ, et al. Three-year follow-up of the tube versus trabeculec- tomy study. Am J Ophthalmol. 2009;148(5):670-684. surface disease by topical medical therapy needs to be rec- 4. Tam D, Calafati J, Ahmed I. Non-penetrating Schlemm’s canaloplasty versus trabeculectomy. ognized and addressed. Also, listen to what your glaucoma Paper presented at: The American Society of Cataract and Refractive Surgery Annual Meeting; April 6, 2009; San Francisco, CA. patients are saying. What do they complain about the most? I will bet you dollars to donuts it is related to (or exacerbated by) the use of their glaucoma drops. Every time a glaucoma patient on topical therapy complains about the cost of his or her drops, the difficulty he or she has remem- bering to use them (alongside his or her dozen or so other medications), tearing, transient blurring, hyperemia, sore eyes, etc., he or she is pleading with you both to listen and to solve the cause of his or her suffering. We now have a rel- atively safe surgical option that can address the very source of our glaucoma patients’ suffering. I think we owe it to them to at least consider the possibility that they would be better served by canaloplasty than by our ignoring their 8 I INSERT TO GLAUCOMA TODAY AND CATARACT & REFRACTIVE SURGERY TODAY I NOVEMBER 2011