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Intraoperative Floppy Iris Syndrome: Pearls for Management and Prevention Senior Instructor: David F Chang MD Course: 214 Sunday, October 16, 2016 10:15 AM - 11:15 AM Room: E451A Published: 8-12-16 12:55 AM Join the conversation: #aao2016 © 2016 American Academy of Ophthalmology. All rights reserved.

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Page 1: Floppy iris Syndrome

Intraoperative Floppy Iris Syndrome:Pearls for Management and PreventionSenior Instructor: David F Chang MDCourse: 214Sunday, October 16, 201610:15 AM - 11:15 AMRoom: E451APublished: 8-12-16 12:55 AM

Join the conversation: #aao2016© 2016 American Academy of Ophthalmology. All rights reserved.

Page 2: Floppy iris Syndrome

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Intraoperative Floppy Iris Syndrome

David F. Chang, MD

Intraoperative floppy iris syndrome (IFIS) in association with current or prior tamsulosin (Flomax) use

was first described in 20051. Besides a tendency for poor preoperative pupil dilation, severe IFIS

exhibits a triad of intraoperative signs – iris billowing and floppiness, iris prolapse to the main and side

port incisions, and progressive intraoperative miosis. Numerous studies have confirmed our initial

suspicion that when such iris behavior is unexpected, the rate of cataract surgical complications is

increased2-7. Based upon parallel large retrospective and prospective clinical studies that John Campbell

and the author had conducted, we identified a strong association of IFIS with either current or prior use

of tamsulosin1. This systemic alpha-1 antagonist is the most commonly prescribed medication for the

symptomatic relief of benign prostatic hyperplasia (BPH). The association of IFIS with other systemic

alpha-1 antagonists such as doxazosin, terazosin, and alfuzosin has since been documented as well4.

Clinical Features

Although our original paper described a triad of signs with what we would now call severe IFIS, there is

a wide range of clinical severity seen in clinical practice. In a prospective study of 167 eyes in patients

taking tamsulosin, we classified IFIS as being mild (good dilation; some iris billowing without prolapse

or constriction), moderate (iris billowing with some constriction of a moderately dilated pupil), or severe

(classic triad and poor preoperative dilation)2. Using this scale the distribution of IFIS severity was -

10% no IFIS, 17% mild IFIS, 30% moderate IFIS, and 43% severe IFIS. The tendency for iris prolapse

often first appears during hydrodissection. Iris billowing may be seen when irrigation from the phaco tip

is introduced, followed shortly thereafter by iris prolapse to both the incision and side port paracentesis.

Progressive intraoperative pupil constriction may occur with our without accompanying iris prolapse.

The combination of progressive miosis and iris floppiness increases the likelihood of aspirating the iris

with the phaco tip.

When surgeons have not recognized or anticipated IFIS, the rate of reported intraoperative

complications has been increased. Multiple retrospective studies have published higher rates of capsular

rupture and vitreous loss1, 4-7. Complications of iris prolapse or aspiration include iridodialysis, iris

sphincter damage, hyphema, and significant iris stromal or transillumination defects. Such iris trauma

can cause permanent pupil deformity with glare or photophobia. In 2009, a retrospective Canadian study

of nearly 100,000 male cataract surgeries documented a doubling of the rate of serious postoperative

complications including retinal detachment, retained nuclear fragments, and severe inflammation in

tamsulosin patients7.

One important caution with IFIS is that partial thickness sphincterotomies and manual pupil stretching

are ineffective and can exacerbate iris billowing and prolapse1, 4. A medical history of systemic alpha-1

antagonist use should alert the cataract surgeon to anticipate IFIS and to consider alternative small pupil

management strategies. Our multicenter, prospective study of 169 consecutive cataract surgeries in

tamsulosin patients attained excellent outcomes with low surgical complications by employing four

specific operative techniques either alone or in combination2. Using Healon 5 viscomydriasis, iris

retractors, preoperative topical atropine administration, or pupil expansion rings, the incidence of

posterior capsule rupture and vitreous loss was less than 1% in this clinical trial. However, because these

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were highly experienced cataract surgeons, this study may not be representative of the general surgical

experience with IFIS. In a 2008 ASCRS membership survey, 95% of the respondents reported that

tamsulosin increased the difficulty of cataract surgery and 77% believed that it also increased the risk of

complications3. Specifically, during the prior two years, IFIS had increased the rate of posterior capsular

rupture for 52% of respondents and the rate of significant iris trauma for 23% of the respondents.

Pharmacology and Mechanism of IFIS

Alpha-1 antagonists relax smooth muscle in the bladder neck and prostate. This facilitates more

complete bladder emptying and thereby reduces the lower urinary tract symptoms of benign prostatic

hyperplasia (BPH). There are at least three common human alpha-1 receptor subtypes - alpha-1A, alpha-

1B, and alpha-1D. Doxazosin (Cardura), terazosin (Hytrin), and alfuzosin (Uroxatral) are considered

non-selective alpha-1 antagonists. Tamsulosin, however, is very selective for the alpha-1A receptor

subtype, which predominates in the prostate as well as in the iris dilator smooth muscle. Because it

theoretically should not block the vascular smooth muscle alpha-1D receptors, tamsulosin has a lower

risk of causing postural hypotension. Although BPH is by far the most common indication, both men

and women may take alpha-1 antagonists for other conditions. Tamsulosin is often briefly prescribed as

an adjunctive medication to faciliate renal stone passage following shock wave lithotripsy. It may also

be prescribed for urinary retention in women, and IFIS has been well documented in female patients

taking tamsulosin. Finally, alpha-1 antagonists, such as doxazosin, terazosin, and prazosin, have long

been prescribed for systemic hypertension. Ophthalmologists should also become familiar with two

newer drugs prescribed for BPH symptoms. Silodosin (Rapaflo) is a systemic alpha blocker that was

FDA approved for BPH in 2008. Like tamsulosin, it is also selective for the alpha-1A subtype, and is

similar to tamsulosin in its strong propensity to cause IFIS. Jalyn is the brand name for the combination

of dutasteride and tamsulosin, and was FDA approved in 2010. The combination of these two agents

was shown in a large prospective clinical trial to be more effective at reducing the progression of BPH

compared to either drug alone.

All alpha-1 antagonists may inhibit pupil dilation and cause IFIS. A number of retrospective and

prospective studies, however, have shown that the frequency and severity of IFIS is much higher with

tamsulosin, as compared with non-selective alpha-1 antagonists3-10. For example, the large retrospective

Canadian study discussed earlier reported that tamsulosin significantly increased the rate of

postoperative complications, but that non-selective alpha antagonists did not7. A second Canadian

retrospective study found that 86% of patients taking tamsulosin developed IFIS compared to only 15%

of patients taking alfuzosin6. A prospective masked trial from Italy comparing phaco in patients taking

tamsulosin versus non-selective alpha blockers, and a large 2011 metanalysis of the literature reached

this same conclusion that IFIS is more common and severe with tamsulosin9, 10. Finally, a large

prospective masked and controlled multicenter clinical study found that severe IFIS was more likely in

patients taking tamsulosin, compared to those taking alfuzosin11. These and other studies were further

supported by the 2008 ASCRS survey finding that 90 percent of respondents with sufficient experience

believed that IFIS was more common with tamsulosin than with nonselective alpha-1 antagonists3. IFIS

may also occur in patients without any history of alpha antagonist use. In addition to confirming that

IFIS was strongly correlated with alpha-1 antagonists, one prospective study found that IFIS was also

associated with systemic hypertension in the absence of alpha blockers

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In our original publication, Campbell and I hypothesized that IFIS was a manifestation of decreased iris

dilator muscle tone and loss of intraoperative structural rigidity1. Two separate slit lamp OCT studies

have reported significant thinning of the mid iris stromal thickness in tamsulosin patients when

compared to control eyes. Another surprising but widespread finding is that IFIS can occur more than

one year after tamsulosin has been discontinued1-4. Ninety-five percent of ASCRS survey respondents

have experienced IFIS in patients with only a prior history of alpha-1 antagonist use3. Tamsulosin can

even be recovered from aqueous samples taken 1-4 weeks after discontinuing the drug, suggesting that is

has a very prolonged receptor binding time. One morphologic study of iridectomy samples from eyes

demonstrating IFIS showed vacuolar degeneration of iris smooth muscle cells12. A subsequent large

histopathologic study of autopsy eyes from patients taking tamsulosin (26 eyes) also showed atrophy of

the iris dilator muscle, which was consistent with a permanent drug effect on iris morphology13. In 2012,

Goseki and co-authors published their in vitro and histologic rabbit studies showing that in addition to

smooth muscle alpha-1 receptors, tamsulosin also binds strongly to pigment granules in the iris. Pigment

epithelial cells share nuclei with the adjacent smooth muscle cells, and this unique morphology may

explain the histopathologic finding of dilator muscle atrophy in tamsulosin treated rabbits. Clearly,

cataract surgical patients should be questioned about any prior alpha-1 antagonist use for this reason.

In conclusion, the mechanism of IFIS is not fully understood. There are several anecdotal reports of IFIS

occurring within days of initiating tamsulosin treatment, meaning that chronic drug use is not necessary

to cause this syndrome. However, the stronger association with tamsulosin compared to non-selective

alpha-1 antagonists and the occurrence of IFIS without any prior alpha blocker use suggests a more

complex mechanism than that simply mediated by blockade of the alpha-1A receptor. IFIS appears to

result from a combination of pharmacologic inhibition of iris smooth muscle contraction, and longer

term smooth muscle degeneration relating to drug accumulation in adjacent iris pigment epithelial

cells14. These permanent structural changes would explain the occurrence of IFIS long after tamsulosin

cessation. A stronger binding affinity to iris pigment granules and alpha-1A receptors might explain the

greater propensity for tamsulosin to cause IFIS compared to non-selective alpha antagonists. Finally,

the strong affinity for some systemic medications, such as psychotropic drugs, to bind to iris pigment

granules might explain the occasional occurrence of IFIS in patients who have never taken alpha

antagonists.

Clinical and surgical management of IFIS

Preoperative management

The possibility of IFIS increases the importance of taking the patient’s medication history prior to

cataract surgery. A history of systemic alpha antagonists may not be elicited without direct questioning

about current or prior use of prostate medication3.

As discussed earlier, stopping tamsulosin preoperatively is of unpredictable and questionable value.

With so many reported cases of IFIS occurring up to several years after the drug had been stopped, it is

clear that ophthalmologists cannot rely solely upon drug cessation to prevent this condition. In the

multicenter prospective trial mentioned earlier, tamsulosin was discontinued prior to surgery in 19% of

patients, but did not result in any significant reduction in IFIS severity in this subgroup of eyes2. In the

2008 ASCRS IFIS survey, 64% of respondents said that they never stop tamsulosin prior to surgery,

compared to 11% who routinely do3.

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Preoperative atropine drops (e.g., 1% t.i.d. for 1-2 days preoperatively) can enhance cycloplegia as a

means of preventing intraoperative miosis15. However, the multicenter prospective tamsulosin study

demonstrated that atropine, as a single strategy, is often ineffective for more severe cases of IFIS2. In the

ASCRS IFIS survey, 57% of respondents said that they never use topical atropine prior to surgery,

compared to 19% who routinely do3.

Surgical management

The inter-individual variability in the severity of IFIS makes it difficult to determine whether one

surgical strategy is superior to another. The severity of IFIS is likely to be greater in patients taking

tamsulosin. Poor preoperative pupil dilation and billowing of the iris immediately following instillation

of intracameral lidocaine are also predictive of greater IFIS severity2, 4, 9. In contrast, if the pupil dilates

well preoperatively, mild to moderate IFIS is more likely but the surgeon should still be prepared for iris

prolapse and miosis. Patients taking non-selective alpha-1 antagonists or who have already discontinued

these medications for several months are most likely to display mild to moderate IFIS.

Ideally, surgeons should be facile with several different approaches that may used alone or in

combination to manage the iris in IFIS. In general, one should make a constructed shelved clear corneal

incision, perform hydrodissection very gently, and consider reducing the irrigation and aspiration flow

parameters if possible. Partial thickness sphincterotomies and mechanical pupil stretching, are

ineffective for IFIS and may worsen the iris prolapse and miosis1, 4.

Intracameral alpha agonists

Intracameral injection of alpha agonists such as phenylephrine or epinephrine, as first reported by

Richard Packard and Joel Shugar respectively, is both a safe and inexpensive strategy for IFIS. By

presumably saturating the alpha 1-A receptors, these agonists can further dilate the pupil. It may take a

minute before the pupil slowly dilates further, but even if it does not, the alpha agonist will often

increase iris dilator muscle tone, reducing billowing and the tendency for prolapse or sudden miosis.

Because of the variable severity of IFIS intracameral alpha agonists work well in some eyes but may

have no detectable effect in others16-19, 4.

In the United States, 1:1000 epinephrine has been commercially available from several manufacturers.

The 30 ml bottle contains the preservative chlorobutanol and should not be used in the eye. Preservative-

free 1:1000 epinephrine is packaged in single use 1 ml vials (1 mg/ml) and comes in two forms - with

and without 0.1% bisulfite as a stabilizing agent. Bisulfite improves the stability of the solution by

delaying oxidation of the active substance, but is toxic to the corneal endothelium due to its high buffer

capacity. In addition, epinephrine taken directly from the vial has a low pH of approximately 3.0.

Therefore, direct intracameral injection of undiluted 1:1000 epinephrine should be avoided. Instead, a

1:4000 epinephrine solution can be easily constituted by adding 0.2 mL of commercially available

1:1000 epinephrine to 0.6 mL of plain balanced salt solution (BSS) or BSS Plus in a 3-mL disposable

syringe. This dilution raises the pH to a physiologic level and appears to sufficiently dilute the bisulfite

stabilizing agent.

Although bisulfite-free 1:1000 epinephrine (American Regent) is theoretically preferred for intracameral

injection, there has been a nationwide shortage in the United States. The 1:4 dilution of bisulfite-

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containing epinephrine has been safely used by the author, and was endorsed in a 2013 ASCRS clinical

alert whenever bisulfite-free epinephrine is unavailable. Adding bisulfite-containing epinephrine to a

500 ml BSS irrigation bottle (off label) will not cause corneal endothelial toxicity because of the

significant dilution. However, shortages of even bisulfite-containing 1:1000 epinephrine are now being

reported in the United States. The author has noted an increased incidence of IFIS despite the absence of

systemic alpha antagonists whenever epinephrine is omitted from the BSS irrigation bottle.

Several publications report the safety and efficacy of unpreserved 1.5% intracameral phenylephrine for

both IFIS prevention and routine surgical mydriasis 17-19. One of these studies found no significant

reduction in endothelial cell counts compared to non-treated eyes.19 Preservative-free phenylephrine

2.5% (Minims) is only commercially available outside the United States. Because these preparations still

contain bisulfite, a 1:4 dilution with BSS, BSS Plus, or preservative-free lidocaine is also recommended.

Lacking a commercial source in the United States, many surgeons (including the author) obtain

bisulfite-free intracameral phenylephrine 1.5% prepared by compounding pharmacies. To avoid

potential toxicity from preservative-containing phenylephrine, ophthalmologists should specify that only

the unpreserved (raw) drug should be used as a compounding source. Prudent precautions for any drug

compounded for intracameral injection include appropriate testing for pH, osmolality, and sterility.

Ophthalmologists should check to see if the compounding pharmacy is accredited by the Pharmacy

Compounding Accreditation Board (PCAB).

When bisulfite-free epinephrine became unavailable, many surgeons questioned whether adding

epinephrine to the BSS irrigating solution was actually necessary. A 2014 study subsequently reported

that omitting epinephrine from the irrigating solution was associated with a 12-13% rate of moderate to

severe IFIS in patients who had previously never taken any systemic alpha antagonists11. Omidria

(Omeros) received FDA approval in 2014. This commercial combination of phenylephrine and ketorolac

is added to the irrigation solution.

As first suggested by Bob Osher and Doug Koch, Healon 5 (Abbott Medical Optics) is a maximally

cohesive ophthalmic visco-surgical device (OVD) that is particularly well suited for viscomydriasis and

for blocking iris prolapse in IFIS. If mydriasis is still suboptimal after injecting epinephrine, Healon 5

can then be used to further mechanically expand the pupil. Viscomydriasis facilitates the capsulorhexis

and combines with the epinephrine-induced iris rigidity to block iris prolapse. However, to avoid

immediately aspirating Healon 5 one must employ low flow and vacuum parameters (e.g. < 175-200

mmHg; < 26 ml/min). This strategy is therefore less suitable if high vacuum settings are desired for

denser nuclei. At higher aspiration flow rates, others have suggested that more dispersive OVDs, such as

DisCoVisc (Alcon) or Viscoat (Alcon), may persist for longer periods within the eye. Finally,

combining Healon 5 with Viscoat has been advocated as a combination strategy whereby the Viscoat

will better resist aspiration and delay the evacuation of Healon 520.

Mechanical pupil expansion with iris retractors or devices such as the Malyugin ring assures a reliably

wide pupil diameter that cannot abruptly constrict during surgery21. Mechanical devices also permit

surgeons to use their preferred OVD, phaco technique, and fluidic parameters. It is easier and safer to

insert these devices prior to creation of the capsulorrhexis. If the pupil dilates poorly preoperatively (e.g.

3 – 5 mm diameter), or billows during injection of intracameral lidocaine, one should consider

proceeding directly to mechanical devices because of the likelihood of severe IFIS. If the pupil dilates

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well preoperatively, but begins to constrict or prolapse after hydrodissection or during phaco combining

intracameral epinephrine and Healon 5 can be an excellent rescue technique that may avoid the need to

insert mechanical devices. If iris retractors are used, one should retract the pupil margin with a second

instrument to avoid hooking the capsulorrhexis margin with the retractors.

Pupil Expansion Rings

Pupil expansion rings are disposable devices that mechanically expand and maintain the intraoperative

pupil diameter. Disposable PMMA rings, such as the Morcher 5S Pupil Ring and the Milvella Perfect

Pupil, have grooved contours are threaded alongside the pupillary margin with dedicated metal injectors.

Eagle Vision’s Graether disposable silicone pupil expansion ring is inserted with a single use plastic

injector. All of these rings are relatively difficult to position if the pupil is less than 4 mm wide or if the

anterior chamber is shallow. They will fail to engage the iris if the pupil diameter is larger than 7 mm.

Most surgeons find the Malyugin ring (Microsurgical technologies, Redmond WA) to be the easiest and

fastest pupil expansion device to insert and remove21. This is a 5-0 polypropylene single use device that

is introduced with a disposable injector. The way in which the iris drapes over the sides of the device

creates a round 6 mm or 7 mm pupil diameter, depending on which of the two available sizes is used.

The disposable injector tip fits through a 2.5 mm incision and is used to both place and extract the ring.

Compared to bulkier and rigid plastic expansion rings, the thin profile of the Malyugin ring reduces the

risk of accidental corneal or incisional trauma and does not impede instrument access to the cataract.

The avoidance of multiple paracentesis sites, is advantageous in the presence of a bleb, a pterygium, and

multiple RK scars, and avoids the problem of iris hooks being pushed against the lid speculum with a

tight palpebral fissure. Finally, the smooth coils are very gentle on the pupil margin, and generally

minimize iris sphincter damage. A similar iris expander device has been introduced by Oasis Medical.

Iris Retractors

The author prefers reusable 4–0 polypropylene retractors (available from Katena Products, Inc.,

Denville, NJ, and FCI Ophthalmics, Inc., Marshfield Hills, MA) to disposable 6–0 nylon retractors

(available from Alcon Laboratories, Inc., Fort Worth, TX). Measuring 0.15mm in diameter, the 4–0

retractors are the same size and stiffness as the polypropylene haptic of an IOL. This greater rigidity,

when compared to 6–0 nylon retractors, makes 4–0 retractors more durable and easier to manipulate.

Furthermore, the 4-0 polypropylene hooks can be repeatedly autoclaved in the manufacturer supplied

storage case, which makes them more cost effective than disposable hooks or pupil expansion rings.

Before initiating the capsulorrhexis, 1-mm limbal paracenteses are created in each quadrant, including a

separate stab incision just posterior to the temporal clear corneal incision. In this way, the phaco tip

passes through a separate incision directly alongside and above the track for the subincisional retractor.

As originally advocated by Oetting and Omphroy, placing the hooks in this diamond configuration has

several advantages. The subincisional hook retracts the iris downward and out of the path of the phaco

tip. This not only provides excellent access to subincisional cortex, but also avoids tenting the iris up in

front of the phaco tip, such as occurs when the retractors are placed in a square configuration. This

configuration also maximizes temporal exposure directly in front of the phaco tip as well as nasal

exposure for placement of the chopper tip. Following IOL implantation, the iris retractors are removed,

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rinsed in balanced salt solution, and gently dabbed with an instrument wipe to remove any viscoelastic

residue. They are then stored in the autoclavable storage container.

Iris retractors both enlarge and maintain an adequate pupillary size throughout the course of surgery.

They provide sufficient tension to the iris stroma so that no prolapse can occur with IFIS. If the pupil is

fibrotic, such as with chronic pilocarpine use or longstanding posterior synechiae, overstretching the iris

can cause bleeding, tear the sphincter, and result in permanent mydriasis. It is therefore advisable to start

with a smaller target diameter than needed with the expectation that the pupil opening will widen further

during phaco. The likely reason for this is that the hydrostatic irrigation force propels the iris posteriorly

against the four-point restraints of the anchored retractors. This effectively acts to mechanically stretch

the pupil margin resulting in microscopic sphincter muscle tears. The exception is the IFIS pupil, which

tends to be elastic and stretches maximally without tearing. Maximal widening with iris retractors can be

employed with IFIS eyes.

Eliciting a history of current or prior alpha-1 antagonist use should alert surgeons to anticipate IFIS and

to employ these strategies either alone or in combination. Because of the variability in IFIS severity,

many surgeons use a staged management approach4, 18. Pharmacologic measures alone may be sufficient

for mild to moderate IFIS cases. Even if they fail to enlarge the pupil, intracameral alpha agonists can

reduce or prevent iris billowing and prolapse by increasing iris dilator muscle tone. If the pupil diameter

is still inadequate, viscomydriasis with Healon 5 can further expand it for the capsulorrhexis step.

Finally, mechanical expansion devices assure the best surgical exposure for severe IFIS, and should be

considered when other risk factors, such as weak zonules or a brunescent nucleus are present.

References:

1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin (Flomax). J Cataract Refract Surg 2005; 31: 664-673.

2. Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin

(Flomax). Ophthalmology 2007;114:957-964.

3. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with

intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201-

1209. 4. Chang DF, Braga Mele R, Mamalis N, et al. for the ASCRS Cataract Clinical Committee. ASCRS White Paper:

Intraoperative Floppy Iris Syndrome – A Clinical Review. J Cataract Refract Surg 2008;34:2153-2162.

5. Chadha V, Borooah S, Tey A, et al. Floppy iris behaviour during cataract surgery: associations and variations. Br

J Ophthalmol. 2007; 91:40-42.

6. Blouin M, Blouin J, Perreault S, et al. Intraoperative floppy iris syndrome associated with Alpha-1

adrenoreceptors. Comparison of tamsulosin and alfuzosin. J Cataract Refract Surg 2007; 33:1227-1234.

7. Bell CM, Hatch WV, Fischer HD, Cernat G, Paterson JM, Gruneir A, Gill SS, Bronskill SE, Anderson GM, Rochon

PA. Association between tamsulosin and serious ophthalmic adverse events in older men following cataract surgery. JAMA 2009; 301:1991-1996.

8. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of

isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J

Cataract Refract Surg 2008; 34: 489-496.

9. Chatziralli IP, Sergentanis TN. Risk factors for intraoperative floppy iris syndrome: a meta-analysis. Ophthalmology

2011;118:730-735.

10. Casuccio A, Cillino G, Pavone C, et. al. Pharmacologic pupil dilation as a predictive test for the risk of

intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454.

Page 9: Floppy iris Syndrome

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11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome

severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834 12. Goseki T, Shimizu K, Ishikawa H, Nishimoto H, Uga S, Nemoto N, Patil PN. Possible mechanism of intraoperative

floppy iris syndrome: a clinicopathological study. Br J Ophthalmol. 2008; 92: 1156-1158

13. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin

(Flomax) on iris dilator smooth muscle anatomy. Ophthalmology. 2010;117:1743-1749.

14. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented

rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649. 15. Masket S, Belani S. Combined preoperative topical atropine sulfate 1% and intracameral nonpreserved

epinephrine hydrochloride 1:4000 [corrected] for management of intraoperative floppy-iris syndrome. J Cataract

Refract Surg. 2007; 33:580-582.

16. Shugar, JK. Intracameral Epinephrine for Prophylaxis of IFIS [letter]. J Cataract Refract Surg 2006; 32: 1074-

1075.

17. Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris syndrome during cataract surgery in

patients on tamsulosin. Eye. 2007; 21:331-332.

18. Manvikar S, Allen D. Cataract surgery management in patients taking tamsulosin. J Cataract Refract Surg 2006; 32:

1611-1614

19. Lorente R, de Rojas V, Vázquez de Parga P, et al. Intracameral Phenylephrine 1.5% for Prophylaxis against

Intraoperative Floppy Iris Syndrome: Prospective, Randomized Fellow Eye Study. Ophthalmology. 2012 Jun 16.

[Epub ahead of print] 20. Arshinoff SA. Modified SST-USST for tamsulosin-associated intraocular floppy iris syndrome. J Cataract Refract

Surg 2006; 32: 559-561.

21. Chang DF. Use of Malyugin pupil expansion device for intraoperative floppy iris syndrome: Results in 30

consecutive cases. J Cataract Refract Surg 2008;34:835-841.

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Intraoperative Floppy Iris Syndrome Associated with Systemic Alpha-1 Antagonists

2014 ASCRS and AAO Educational Update Statement for Prescribing MDs

In 2005 the U.S. Food and Drug Administration issued a new label warning about the association of α1-

antagonists and intraoperative floppy iris syndrome (IFIS). Characterized by sudden intraoperative iris

prolapse and pupil constriction, IFIS increases both the difficulty and the risk of cataract surgery1. Some

complications of IFIS have been sight threatening, including retinal detachment, lost lens fragments,

endophthalmitis, and severe iris defects associated with permanent pupil deformity, glare, and

photophobia1-3. Tamsulosin is the most commonly prescribed α1-antagonist for benign prostate

hyperplasia (BPH) in North America. Until the approval of silodosin, tamsulosin was the only systemic

α1-antagonist that is selective for the α1-A receptor subtype that predominates in the prostate. Because

vascular smooth muscle receptors are α1-B, the theoretical advantage of such receptor subtype

selectivity is reduced risk of postural hypotension. Although initial blood pressure monitoring may be

recommended when prescribing older non-selective α1-antagonists, such as terazosin and doxazosin,

another non-selective α1-antagonist, alfuzosin, rarely causes postural hypotension and is associated with

fewer cardiovascular adverse events 4-6.

It is well recognized that simply discontinuing oral α1-antagonists does not prevent IFIS1. Studies of

rabbit and human cadaver eyes have shown that tamsulosin is associated with atrophy of the iris dilator

smooth muscle, and that this may be due to concentration of the drug in iris pigment granules7,8. In

2008, the American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy

of Ophthalmology (AAO) jointly issued an educational update advisory on IFIS asking prescribing

physicians to consider involving the cataract surgeon prior to initially prescribing non-emergent, chronic

α1-antagonists in patients with known cataracts. Prescribing physicians were also asked to encourage

patients to report any prior or current history of α1-antagonist use to their ophthalmic surgeon prior to

undergoing any eye surgery.

Since the 2008 advisory statement, additional evidence has emerged showing that severe IFIS is more

likely to occur with tamsulosin compared to non-selective α1-antagonists. A 2011 meta-analysis of 17

published studies found that tamsulosin had a 40-fold higher pooled odds ratio for IFIS compared to

alfuzosin and terazosin9. A subsequent prospective, masked single surgeon study found severe IFIS

more commonly with tamsulosin compared to non-selective α1-antagonists as a group10. Finally, a

newly published multicenter prospective study found that severe IFIS was statistically more likely with

tamsulosin than alfuzosin11. This was the first prospective, masked and controlled study to specifically

compare two α1-antagonists with a low reported incidence of cardiovascular adverse events. In a 2008

survey, nearly two thirds of ophthalmologists said that if they themselves had a mildly symptomatic

cataract they would either avoid tamsulosin or have their cataract removed first 12.

A newly published survey of primary care physicians from the University of California, San Francisco

showed that only 35% were aware that α1-antagonists can cause cataract surgical complications; only

half (17%) factored this into treatment considerations13. Less than 10% inquire about a history of

cataract prior to initiating α1-antagonist treatment and only 31% regularly advise patients to inform their

ophthalmologist about taking these drugs. Most respondents (96%) desired more information on this

topic.

Page 11: Floppy iris Syndrome

10

We are issuing this updated educational statement for prescribing physicians based on these two newly

published reports. Patients with symptomatic cataracts may wish to consider cataract surgery prior to

initiating non-emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of

IFIS, patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment.

References:

1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris

syndrome. J Cataract Refract Surg 2008;34:2153-2162.

2. Bell CM, Hatch WW, Fischer HD, et al. Association between tamsulosin and serious ophthalmic adverse events

in older men following cataract surgery. JAMA 2009;301(19):1991-1996. 3. Chang DF. Floppy Iris Syndrome: Why BPH can complicate cataract surgery. Am Fam Physician 2009; 79:

1051, 1055-1056.

4. McVary KT, Roehrborn CG, Avins AL, et al. Update on AUA guideline on the management of benign prostatic

hyperplasia. J Urol 2011; 185:1793-1803.

5. Buzelin JM, Delauche-Cavallier MD, Roth S, et al. Clinical uroselectivity: evidence from patients treated with

slow-release alfuzosin for symptomatic benign prostatic obstruction. Br Journal Urol 1997;79:898-906.

6. Roehrborn CG. Alfuzosin: overview of pharmacokinetics, safety, and efficacy of a clinically uroselective alpha-

blocker. Urology 2001;58:55-63.

7. Santaella RM, Destafeno JJ, Stinnett SS, et al. The effect of alpha1-adrenergic receptor antagonist tamsulosin

(Flomax) on iris dilator smooth muscle anatomy. Ophthalmology 2010;117:1743-1749.

8. Goseki T, Ishikawa H, Ogasawara S, et al. Effects of tamsulosin and silodisin on isolated albina and pigmented rabbit iris dilators – Possible mechanism of IFIS. J Cataract Refract Surg 2012;38: 1643-1649.

9. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis.

Ophthalmology 2011; 118:730-735.

10. Casuccio A, Cillino G, Pavone C, et al. Pharmacologic pupil dilation as a predictive test for the risk of

intraoperative floppy-iris syndrome. J Cataract Refract Surg 2011;37: 1447-1454.

11. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome

severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121:829-834

12. Chang DF, Braga-Mele R, Mamalis N, et al., for the ASCRS Cataract Clinical Committee. Clinical experience with

intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg. 2008;34:1201-

1209. 13. Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of IFIS. J Cataract Refract Surg

2014;40: 685-686

Page 12: Floppy iris Syndrome

11

New studies on IFIS prompt ASCRS/AAO Educational Update for Prescribing Physicians

(EyeWorld, April 2014) David F. Chang MD

Two new studies on intraoperative floppy iris syndrome (IFIS) that I was involved with will be

published this month, and they have prompted a renewed joint effort by ASCRS and AAO to educate

prescribing physicians about the potential adverse effects of systemic α1-antagonists on cataract surgery.

The first study (Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of

intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology 2014;121

(April):829-834) adds to the mounting evidence that tamsulosin creates a higher risk of severe IFIS,

compared to non-selective α1-antagonists.

Of the α1 receptor sub-types, the α1A receptor predominates in both the iris dilator and prostatic smooth

muscle. Among α1-antagonists prescribed for benign prostatic hyperplasia (BPH), only tamsulosin and

silodosin are sub-type selective and demonstrate the highest affinity for the α1A-receptor. Such receptor

uroselectivity reduces the risk of postural hypotension due to blockade of the α1B receptors in vascular

smooth muscle. All of the α1-antagonists can impair pupil dilation and cause IFIS. However, a number

of prospective and retrospective studies have suggested that the frequency and severity of IFIS is greater

in patients taking tamsulosin compared to the non-selective α1-antagonists, such as terazosin, doxazosin,

and alfuzosin1, 2. A 2011 meta-analysis of 17 published studies reported that tamsulosin had a 40-fold

higher pooled odds ratio for IFIS compared to alfuzosin and terazosin2. In vitro experiments

demonstrated that tamsulosin is a much stronger antagonist of rabbit iris dilator muscle contraction than

alfuzosin3. Finally, a 2008 survey of ASCRS members indicated that 90% of respondents (with enough

personal experience) felt that IFIS was more common with tamsulosin than with non-selective α1-

antagonists4.

Because many of the prior studies were retrospective and were not masked, my co-investigators and I

decided to conduct a multicenter prospective, masked, controlled comparison of tamsulosin and

alfuzosin - the two α1-antagonists with the fewest reported cardiovascular adverse events. Undoubtedly

one of the reasons that tamulosin became the most prescribed treatment for BPH was its theoretical

uroselectivity and reduced incidence of postural hypotension. Although it is a non-selective α1-

antagonist, alfuzosin is often referred to as “clinically uroselective”. The reduction in postural

hypotension with alfuzosin is not due to receptor specificity, but rather to pill reformulation to slow

release of the molecule in the GI tract.

The study was conducted in France, where alfuzosin is more commonly prescribed than in most other

countries. Sanofi Aventis, the manufacturer of alfuzosin (Uroxatral) is a French pharmaceutical

company. Eight study surgeons from four sites enrolled 113 consecutive patients taking either

tamsulosin or alfuzosin. Each time a study patient was enrolled, a control patient with no prior history of

α1-antagonist use was enrolled by the same cataract surgeon on the same day. All 226 cases were

videotaped and two masked ophthalmologists (John Campbell and myself) then graded every video for

the presence and severity of IFIS. Severe IFIS—defined as iris billowing and prolapse with ≥ 2 mm of

pupil constriction— was more common with either α1-antagonist compared to control eyes. However,

severe IFIS was noted in 34.3 percent (24/70) of the tamsulosin eyes and 16.3 percent (7/43) of the

alfuzosin eyes (P< 0.05). Therefore, if an α1-antagonist with a lower risk of cardiovascular side effects

is indicated, patients with cataracts may want to try alfuzosin first.

Page 13: Floppy iris Syndrome

12

Unfortunately for cataract surgeons, tamsulosin continues to be the most frequently prescribed

medication for BPH, and its use will surely rise now that it is generic in the United States. As an

alternative to α1-antagonists, 5-α reductase inhibitors (dutasteride and finasteride) are also effective and

approved as medical monotherapy of BPH. However, a large multinational randomized trial

demonstrated that the combination of dutasteride and tamsulosin was superior to either drug alone in the

prevention of BPH progression. Ophthalmologists must therefore recognize that Jalyn is the brand name

for this specific drug combination. Finally silodosin (Rapaflo) is the most recent α1-antagonist to be

approved for BPH and most resembles tamsulosin in its α1A receptor sub-type specificity.

The second study (Doss EL, Potter MB, Chang DF. Primary Care Physicians Still Lack Awareness of

IFIS. J Cataract Refract Surg 2014;40 (April): 685-686) was a survey of primary care physicians from

the University of California, San Francisco (UCSF) designed to assess their α1-antagonist prescribing

patterns and their awareness of IFIS. A brief questionnaire was emailed to 350 health care providers in

the UCSF Collaborative Research Network and 133 responded. Forty percent initiate BPH medical

treatment at least twice a month. Overall, only 35% were aware that α1-antagonists can cause cataract

surgical complications; only half (17%) factored this into treatment considerations. Less than 10%

inquire about a history of cataract prior to initiating α1-antagonist treatment and only 31% regularly

advise patients to inform their ophthalmologist about taking these drugs. Most respondents (96%)

desired more information on this topic.

Based on the new information from these two studies, the ASCRS Cataract Clinical Committee decided

that a renewed effort to educate prescribing physicians treating BPH should be initiated. We have

collaborated with the AAO in writing a joint educational document that was formally issued in early

April. This new document updates the 2008 joint ASCRS/AAO IFIS educational statement which asked

1) prescribing physicians to consider involving the ophthalmologist prior to initiating α1-antagonists in

patients with known cataracts and 2) reminding patients taking systemic α1-antagonists to report this

medication history prior to having any eye surgery. The newly issued educational statement states,

“Patients with symptomatic cataracts may wish to consider cataract surgery prior to initiating non-

emergent α1-antagonist therapy. Because tamsulosin is associated with the highest risk of IFIS,

patients with cataracts may wish to consider a non-selective α1-antagonist as initial treatment”. We

have communicated with the American Academy of Family Physicians, the American College of

Physicians, and the American Urological Association who will each help to disseminate this information

to their respective memberships. In addition, this document is a concise, referenced summary that

ophthalmologists can share with prescribing doctors in their communities on an individual basis. It can

be downloaded from the ASCRS web site www.ascrs.org

1. Chang DF, Braga-Mele R, Mamalis N, et al. ASCRS white paper: clinical review of intraoperative floppy-iris syndrome. J Cataract Refract Surg 2008;34:2153-2162.

2. Chatziralli IP, Sergentanis TN. Risk Factors for intraoperative floppy iris syndrome: A meta-analysis. Ophthalmology 2011; 118:730-735.

3. Palea S, Chang DF, Rekik M, et al. Comparative effect of alfuzosin and tamsulosin on the contractile response of

isolated rabbit prostatic and iris dilator smooth muscles. Possible model for intraoperative floppy iris syndrome. J

Cataract Refract Surg 2008; 34: 489-496.

4. Chang DF, Braga-mele R, Mamalis N, et al. Clinical experience with intraoperative floppy-iris syndrome. Results of the 2008 ASCRS member survey. J Cataract Refract Surg 2008; 34:1201-1209.

Page 14: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

1

Managing Flomax IFIS (with OVDs*) A Step Ladder Approach

*Arshinoff Steve A. Modified SST-USST for tamsulosin-associated intraocular floppy-iris syndrome. JCRS 2006; 32: 559-561. April.

Course 418

Oct. 20, 2014

Incision

1. Viscoat filled space (injected 1st)

2. Viscoadaptive filled space (injected 2nd)

3. BSS filled space (injected 3rd)

I F I S S S B r i d g e

Steve A. Arshinoff MD FRCSC Eye Associates, Humber River Hospital University of Toronto, Toronto, ON, Canada McMaster University, Hamilton, ON, Canada

Financial Disclosures: Alcon Laboratories Inc. - C Abbott Medical Optics - C Bausch & Lomb – C Anteis – C iMed Pharma - C Arctic Dx. - C

Two physical components of Phaco:

Phaco power modulations Rheology

= Control of flow in, & maintenance of, the AC.

OVDs are pseudoplastic fluids used to create an AC surgical environment optimized for surgery.

Creative use of OVDs reduces complication rates.

“Phaco is Rheology”

TSST Arshinoff SA, Norman R. JCRS 2013; 39: 1196-1203.

Tri-Soft Shell Technique (TSST)

logical system of unification of soft

shell techniques to make them easier

to understand & perform.

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Page 15: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

2

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Warn    Flomax    pts:    

Flomax  pa=ents  are  asked  to  

have  their  doctor  change  them  to  a  different  BPH  α  blocker    

before  surgery.    

(  This  may  not  make  much  difference.  )  

Step  1:    Carefully  examine  iris  &  pupil  

�  See  all  small  pupil  cases  ≤  2  weeks  preop!    

-­‐  Is  it  IFIS  or  “pseudo  IFIS”?          Iris  atrophic?    post  synechiae?  

   Fibro=c  pupillary  ring?    

�  Preop  pupil  dila=on  test:  1.   tropicamide  1%  gDs  x  2,  

phenylephrine    2.5%  x  1  2.   wait  20  min:    observe  …  

Flomax  effect  is  variable!!    Blue  eyes  much  worse  than  brown.  

> 6.5 mm = no problem - 2x adrenaline in bottle

- intracam. Xylo-phe.

~ 6.0 mm = minor problems - tight incisions !! - IFIS Soft Shell Bridge

< 5.5 mm = serious IFIS - expect trouble. - ? + Malyugin Ring

no dilation = not likely Flomax – stretch pupils

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Page 16: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

3

Step  2:    Preparing  the  AC  for  IFIS  

1.  Use  IC  xylo-­‐phe  &  2  x  adrenaline  in  the  boZle.  -­‐  1cc.  intracardiac  1:1,000  adrenaline  /  500  cc  BSS      

2.  Long,  =ght  incisions    -­‐  prevent  iris  prolapse.  

*Arshinoff Steve. Cataract Surgery in Compromised Endothelium. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013.

*

Intracameral    Sympathomime=c    Agents  

                                   Agent:        Source    “stabilizer”  

1.  Irrigant  boZle  Epinephrine  1mg/ml        Hospira                        metabisulfite  -­‐  1:500  dilu=on  in  irrigant  BSS  

2.  *Non-­‐preserved  Epi  injec=on,  USP  1:1,000  American  Regent              none  1  ml  ampules:  **dilute  1:3  with  BSS  –  J  Shugar  

3.    +Phenylephrine  10%  minims  diluted  in  5  cc  BSS                    Chauvin  (B&L)  metabisulfite      -­‐  1st  proposed  by  David  Allen,  Richard  Packard        Na2EDTA      

* Slack JW, Edelhauser HF, Helenek MJ. A bisulfite-free intraocular epinephrine solution ** Shugar J. Epinephrine for IFIS prophylaxis. JCRS 2006: 32; 1074-1075 + Manvikar S, Allen D. cat surg in pts taking tamsulosin. JCRS 2006. 32: 1611-14. Packard R. CRST 2007. May.

Xylocaine –Phenylephrine to facilitate cataract surgery

INTRACAMERAL MYDRIATICS IN PHACOEMULSIFICATION

The mean corneal endothelial cell loss at 1 monthwas 2.3% ! 6.1% in the intracameral group and4.1% ! 6.0% in the topical group (P " .25) (Table1). The postoperative cell counts were not significantlydifferent from the preoperative values (P " .19 andP " .17, respectively). In contrast, cells were moreirregular and elongated postoperatively in both the in-tracameral group and the topical group as assessed byHSF (P " .0092 and P " .0010, respectively) and byDE (P " .0037 and P#.001, respectively); there wereno significant differences between the groups (Table 1).

A significant decrease in pulse rate occurred in thetopical group (P " .0055) but not in the intracameralgroup (P " .15). The difference in pulse decelerationFigure 1. (Lundberg) Pupil size (mean ! SD) after injection of intra-

cameral mydriatics (s " seconds). was significant between the groups (Table 1). Theslightly increased postoperative MAP did not differ sig-nificantly from the preoperative values in either the

sure $ 1/3 % diastolic blood pressure $ 2/3. Finally, all intracameral group or the topical group (P " .072 andpatients graded their subjective sensation of pain and glare P " .10, respectively).during the procedure using a visual analog scale from 0 to 10.

Complications in the intracameral group were 1A binary logistic regression model was used to evaluatecase of slight damage to the capsulorhexis and in thewhether preoperative differences existed between the groups

in BCVA, IOP, pseudoexfoliation, iris color, cataract classifi- topical group, 1 case each of iris prolapse and posteriorcation, corneal endothelial cell count, pupil size, corneal capsule rupture without vitreous loss. Mechanical pupilthickness, pulse, MAP, age, or sex. There were no significant dilation was performed in 3 eyes in the intracameraldifferences in the preoperative parameters between the 2 groups

group and 1 eye in the topical group.(P " .72). The Mann-Whitney U test was used to evaluatepain, glare, and cell and flare data, and the Student2-tailed t test was used for all other statistical comparisons. A DiscussionP value less than 0.05 was considered statistically significant.Mean values are given with their standard deviations. This study shows that mydriatics can be safely in-

jected into the anterior chamber before phacoemulsifi-cation cataract surgery in sufficient doses to allow theResultsprocedure to be performed without topical mydriatics.In the intracameral group, the pupils reachedMixing intracameral mydriatics with lidocaine 1% sim-95% ! 3% (SD) of their maximum size after 20 secondsplifies their administration and is probably why patients(Figure 1). The mean pupil size after viscoelastic injec-in the intracameral group reported less discomfort thantion was smaller in the intracameral group (6.7 !patients in the topical group, in whom only lidocaine1.0 mm) than in the topical group (7.7 ! 1.0 mm)was injected. Patients in the intracameral group reported(P#.001), but the pupils in the intracameral groupless discomfort from glare, probably because a normal-often continued to enlarge throughout the proceduresized pupil at the initiation of the procedure allows(%4.5% ! 8.1%), whereas the pupils in the topicalmore gradual adaptation to the microscope light. It isgroup tended to contract (&2.1% ! 7.8%) (P "likely that direct action of lidocaine on the pupil sphinc-.0020). The between-group difference in pupil size be-ter contributes to the mydriasis after the intracameralfore IOL implantation was therefore smaller (7.0 !mydriatic injections. On the other hand, the anesthetic0.9 mm versus 7.5 ! 0.9 mm) but still significanteffect of lidocaine on the iris may partially counteract(P " .040). At 1 day, the pupils in the intracameralthe effect of the active mydriatic (phenylephrine). Wegroup were significantly larger than in the topical group

(5.7 ! 1.1 mm versus 3.7 ! 0.8 mm) (P#.001). are performing a study to separately quantify the effects

J CATARACT REFRACT SURG—VOL 29, DECEMBER 20032368

Xylo + 0.1% Phe

1st proposed: Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. JCRS 2003; 29: 2366-71. used 0.1%phenylephrine

Intracameral Phenylephrine �  Dose response: Behndig A, Lundberg B.

Mydriatic response to different concentrations

of intracameral phenylephrine in humans.

JCRS 2010; 36:1682-86.

≥ 1.5% phenylephrine yields superior dilation.

�  IFIS: Gurbaxani A, Packard R. Intracameral phenylephrine to prevent floppy iris

syndrome during cataract surgery in patients on

tamsulosin. Eye 2007; 21: 331-2

Diluted phenylephrine B&L minims 2.5%: Add 0.25 ml + 1 ml BSS è 0.5%

�  Bill Myers (Chicago) – IC phenylephrine obtained from Leiter’s in US.

�  Ramon Lorente (Spain) – 1.5% phenylephrine IC for IFIS. Ophthalmology 2012; 119: 2053-8.

Figure 1. Mean pupil sizes over time after intracameral injection of 0.15 mL phenylephrine at different concentrations

≥ 1.5%

< 1.5%

Phe

Page 17: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

4

IC xylo-phe 1.  Add minim (0.3 cc) 10% phenylephrine to 5 cc BSS in 6 cc

syringe (è 0.57%, diluted 17.7x).

2.  Add 3-4 drops of above phenylephrine solution to xylocaine (Astra 1% non-preserved insotonic xylo polyamp) on scrub tray (è0.05%, diluted ≥200x).

3.  Inject 0.1 cc IC xylo-phe thru side port. (1.) �  Almost all pupils dilate to 8-9 mm in 10 seconds.

4.  Inject 0.1 cc IC xylo-phe under OVD. (2.) �  1 more mm of pupil dilation.

IC xylo-phe: Why it works so well.

�  Xylocaine: Completely paralyzes sphincter.

�  Phenylephrine: Aggressively stimulates dilator.

* Benefits: 1. Maximally enhances iris tone.

2. Great for all cataract cases.

3. Adequate for 90+ % IFIS cases.

4. Safe

IC xylo-phe

If you would like this

xylo-phe formulation

& use sheet, please

email me at:

[email protected]

Page 18: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

5

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Step 3: Create IFIS Soft Shell Bridge

1.  Tamponade  peripheral  Iris  with  Viscoat.  

2.  Blockade  &  Bridge  central  AC  with  Healon5.  

3.  LiF  H5  away  from  ant.  capsule  with  BSS,  or  xylo-­‐phe.  

4.  Keep  capsulorhexis  smaller  than  pupil.  

Incision

1. Dispersive filled space (injected 1st)

2. Viscoadaptive filled space (injected 2nd)

3. BSS or xylo-phe filled space (injected 3rd)

I F I S S S B r i d g e

TSST & SSB

Tri-Soft Shell Technique Soft Shell Bridge Arshinoff SA, Modabber M. Cataract Surgery in Intraoperative Floppy Iris Syndrome (IFIS) Eyes. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013.

Arshinoff Steve. Cataract Surgery in Compromised Endothelium. In Chakrabarti A. Cataract Surgery in Diseased Eyes. Jaypee Brothers Ltd., New Delhi. 2013.

è

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Page 19: Floppy iris Syndrome

Steve A Arshinoff MD FRCSC OVD Stepladder Approach to IFIS AAO 2014

6

Step  4…    Performing  Phaco  with  IFIS  SS  Bridge  

1.  Use  low  flow  →  low  turbulence  (Ozil).  

1.   Asp  flow  rate  ~  15-­‐25  cc/min.  

2.  Vacuum  <  250  mm  Hg.  

3.  BoZle  height  ~  75  cm  above  pt’s  head  

2.  Keep  phaco  and  I/A  =ps  deep  to  ‘rhexis.  

3.  Reinject  H5  (rarely  Viscoat)  as  needed:  (e.g.  aFer  hydrodissec=on)  

Incision

1. Dispersive filled space (injected 1 s t)

2. Viscoadaptive filled space (injected 2 nd ) 3. BSS or xylo-phe

filled space (injected 3 rd )

Successfully  Managing  IFIS  with  OVDs  �  Step  1:    Study  the  eye  &  warn  pa=ent.    

   Perform  preop  dila=on  test.    

�  Step  2:  Prepare  the  AC.    

�  Step  3:  Create    IFIS  SoF  Shell  Bridge      (SSB)          

�  Step  4:  Perform  low  flow,  low  turbulence  surgery.    

�  Step  5:  Malyugin  Ring      (or  iris  retractors)  rarely  needed  

Summary: IFIS SS Bridge

1.  Considerable  varia=on  in  sensi=vity  to  Flomax.  �  Preop  dila=on  test,  IC  phenylephrine  

2.  IFIS  SS  Bridge  enables  safe,  easy  management  of  most  IFIS  cases.  

3.  Reestablish  the  IFIS  SSB  structure  when  necessary  (H5).  

4.  Boris  Malyugin’s  ring  (MST)  (Fyodorov  Ins=tute  Moscow).  

*Arshinoff Steve A. Modified SST-USST for tamsulosin-associated intraocular floppy-iris syndrome. JCRS 2006; 32: 559-561. April.

Incision

1 Dispersive filled space (injected 1 st )

2. Viscoadaptive filled space (injected 2 nd ) 3. BSS or xylo- phe

filled space (injected 3 rd )

STEVE A. ARSHINOFF MD FRCSC [email protected]