how conductive keratoplasty is impacting the presbyopic practice

6
1 Abstract CK has been commercially available in the United States for a little over 3 years. Refractec engaged SM 2 Consulting to field a research survey to assess how surgeons are integrating this technology into their treat- ment of presbyopia. Surgeons indicate that CK clinical outcomes have improved dramatically using the “LightTouch” technique, restoring their confidence and usage of the procedure. Also, the CK patient population is dramatically different from that in a typical refractive or cataract practice, and successful physicians have adjusted their protocols to better attract, counsel and manage these patients, significantly increasing patient satisfaction with the CK procedure. Perhaps more importantly, CK serves as the first entry point into med- ical eye care services for many of these patients. Some surgeons are using the opportunity to build a relation- ship with these patients now, as they will likely need more eye care services (IOL’s, Glaucoma treatment, etc.) over the next 10-20 years. Introduction Refractec (Irvine, CA) manufactures and sells a refractive treatment system that allows ophthalmologists to perform Conductive Keratoplasty (CK), a procedure which utilizes radio frequency waves applied via a hand-held probe to alter the shape of the cornea. The original application of CK was for hyperopia, with the goal of steepening the outer optical zone to induce a refractive change. Consequently, the Company has received additional FDA approvals to market the device for the improvement of near vision in emmetropic presbyopes and low hyperopic presbyopes, using similar methods. SM 2 Consulting (Pleasanton, CA) was retained by Refractec to conduct independent research interviews with surgeon cus- tomers to assess the impact the technology is having in the typi- cal customer practice and to help better understand the motivation and concerns of the patients for the CK procedure. Methods A set of research objectives, discussion guide and data collec- tion processes were developed and research interviews were con- ducted from a sample of 20 practices. Enrolled practices represent a wide distribution by geography and by practice type (see Table 1). Most of the surgeons interviewed have been using the CK device for several years (mean = 2.6 years), with a range that included a relatively new user (3 months) and two of the original clinical investigators (7 years experience each). Questions focused on their current clinical experience with CK, with the additional goal of understanding patient motivation and management with this procedure. Data were also collected on recent practice refractive procedure volume and pricing to understand where CK fits economically within the practice. Results CK Clinical Outcomes: Much Better with “LightTouch” 19 of 20 surgeons interviewed had experience with the new “LightTouch” technique. Physicians who use this new approach feel they are achieving significantly improved results over the conventional pressure technique. 18 of 20 had experience with both the new and original techniques and could draw direct comparisons between the treatment methods. LightTouch offers the surgeon the ability to treat with fewer spots in a single ring placed further outside the optical zone. More refractive effect is achieved and there is a near elimination of the induced cylinder commonly observed post-operatively with the conventional method. The LightTouch method has generated a high level of confi- dence in CK among the surgeons that were interviewed. How Conductive Keratoplasty is Impacting the Presbyopic Practice Shareef Mahdavi SM 2 Consulting Pleasanton, CA SM 2 Survey of CK Surgeons (N=20), June 2005 Table 1: Demographics of CK Practices in Survey (N = 20) 4 2 7 7 >450 301 to 450 151 to 300 0 to 150 Quarterly LASIK Volume (# of eyes treated in Q1 2005) 3 4 7 6 West South Central North Central East Location 5 3 6 6 Cornea Specialist General Refractive and Cataract Refractive Type of Practice

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Page 1: How conductive keratoplasty is impacting the presbyopic practice

1

AbstractCK has been commercially available in the United

States for a little over 3 years. Refractec engaged SM2

Consulting to field a research survey to assess howsurgeons are integrating this technology into their treat-ment of presbyopia. Surgeons indicate that CK clinicaloutcomes have improved dramatically using the“LightTouch” technique, restoring their confidence andusage of the procedure. Also, the CK patient populationis dramatically different from that in a typical refractiveor cataract practice, and successful physicians haveadjusted their protocols to better attract, counsel andmanage these patients, significantly increasing patientsatisfaction with the CK procedure. Perhaps moreimportantly, CK serves as the first entry point into med-ical eye care services for many of these patients. Somesurgeons are using the opportunity to build a relation-ship with these patients now, as they will likely needmore eye care services (IOL’s, Glaucoma treatment, etc.)over the next 10-20 years.

IntroductionRefractec (Irvine, CA) manufactures and sells a refractive

treatment system that allows ophthalmologists to performConductive Keratoplasty (CK), a procedure which utilizes radiofrequency waves applied via a hand-held probe to alter theshape of the cornea. The original application of CK was forhyperopia, with the goal of steepening the outer optical zone toinduce a refractive change. Consequently, the Company hasreceived additional FDA approvals to market the device for theimprovement of near vision in emmetropic presbyopes and lowhyperopic presbyopes, using similar methods.

SM2 Consulting (Pleasanton, CA) was retained by Refractecto conduct independent research interviews with surgeon cus-tomers to assess the impact the technology is having in the typi-cal customer practice and to help better understand themotivation and concerns of the patients for the CK procedure.

MethodsA set of research objectives, discussion guide and data collec-

tion processes were developed and research interviews were con-ducted from a sample of 20 practices. Enrolled practices

represent a wide distribution by geography and by practice type(see Table 1). Most of the surgeons interviewed have been usingthe CK device for several years (mean = 2.6 years), with a rangethat included a relatively new user (3 months) and two of theoriginal clinical investigators (7 years experience each).Questions focused on their current clinical experience with CK,with the additional goal of understanding patient motivationand management with this procedure. Data were also collectedon recent practice refractive procedure volume and pricing tounderstand where CK fits economically within the practice.

ResultsCK Clinical Outcomes: Much Better with “LightTouch”

19 of 20 surgeons interviewed had experience with the new“LightTouch” technique. Physicians who use this new approachfeel they are achieving significantly improved results over theconventional pressure technique. 18 of 20 had experience withboth the new and original techniques and could draw directcomparisons between the treatment methods. LightTouch offersthe surgeon the ability to treat with fewer spots in a single ringplaced further outside the optical zone. More refractive effect isachieved and there is a near elimination of the induced cylindercommonly observed post-operatively with the conventionalmethod.

The LightTouch method has generated a high level of confi-dence in CK among the surgeons that were interviewed.

How Conductive Keratoplasty is Impacting the Presbyopic Practice

� Shareef Mahdavi • SM2 Consulting • Pleasanton, CA �

SM2 Survey of CK Surgeons (N=20), June 2005

Table 1: Demographics of CK Practices in Survey (N = 20)

4277

>450301 to 450151 to 3000 to 150

Quarterly LASIK Volume(# of eyes treated in Q1 2005)

3476

WestSouthCentral

NorthCentralEast

Location

5366

CorneaSpecialistGeneral

Refractiveand

CataractRefractive

Type of Practice

Page 2: How conductive keratoplasty is impacting the presbyopic practice

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As shown in Figure 1, the average confidence was 8.6 (on a 1 to10 scale, 10 being highest) and no surgeon rated their confi-dence below a 7. Although not directly asked, surgeons indi-cated that the reason for their high confidence was directlyattributable to the LightTouch method. Had they been askedthis question a year ago, confidence levels would have beenrated much lower.

Many surgeons have noticed a difference in the immediacyof the effect of CK, with LightTouch providing a stronger“WOW! Factor” based on the statements of patients who havehad the new procedure. Although LightTouch has been in use alittle more than one year, surgeons indicate that the incidence ofretreatment is already significantly less than what they experi-enced with the original technique.

The leading indication for CK use is for primary treatment ofplano presbyopes (100%), followed by 11 of 20 surgeons (55%)who use CK for post-LASIK refinement. Thirty percent of thoseinterviewed will also treat mild hyperopes bilaterally, and 25%indicate they are using it for refinement of IOL implant results

(cataract and/or refractive implants). See Figure 2.CK Candidates: A Different Audience

The patient wanting CK is not likely to be found in thewaiting room of a typical ophthalmic surgeon’s practice. Theyfit somewhere between the typical LASIK patient (younger,myopic, haven’t enjoyed unaided vision for years) and the typi-cal IOL patient (older, having other aging and health issues).Many patients that choose CK have never had a relationshipwith an eye care professional and only now are in need of helpwith their vision. Blessed with good distance vision all theirlives, they reach their late 40s and find themselves increasinglyfrustrated and even angry at their inability to perform near andintermediate visual tasks. The frustration can be classified interms of the physical and emotional context of getting older.When paired with the view that there is nothing redeemingabout wearing reading glasses, the CK candidate comes in say-ing, “I feel old and I look old.” All surgeons reported the aver-age CK patient age is from 48 to 52 years of age, which can beamong the most active and financially productive years of aperson’s life. The motivation for CK is simple: reduce depend-ency on reading glasses.

Similar to research conducted about motivation for LASIK,the CK patient also wants to improve performance. In the con-text of presbyopia, performance means being able to read thecell phone, price tags, restaurant menu, and newspaper withoutthe need for reading glasses.

Surgeons also reported that many of their CK patients wouldnever have had LASIK, either because they didn’t need it for dis-tance correction or due to perceived risk. In contrast to usinglasers and keratomes, CK allows surgeons to offer a less invasiveapproach which serves as a “stepping stone” before more dra-matic procedures will be required (or desired) later on in life.CK can be compared to other less invasive self-improvementoptions available at midlife: Botox before a facelift, teethwhitening before veneers, and collagen injection before kneereplacement.

This low level of invasiveness resonates very deeply withsomeone who has had “perfect eyes” for 50 years. The moreconservative and mature profile of this age group is a good fitwith a procedure that gives back capability they previouslyenjoyed.

CK Surgeons: Setting ExpectationsHow the surgeon sets expectations with patients is perhaps

the single most critical factor in achieving success with CK.These patients have emotional needs that differ greatly from thatof the typical LASIK or cataract patient. Sometimes described as

0

1

2

3

4

5

6

7

1 2 3 4 5 6 7 8 9 10

Confidence Rating (1 = lowest, 10 = highest)

Figure 1: As a surgeon, how would you rate your confidence in the CK procedure?

SM2 Survey of CK Surgeons (N=20), June 2005

Mean Rating =8.6

# o

f P

ract

ices

100%

55%

30%

25%

0 % 20% 40% 60% 80% 100%

PlanoPresbyopes

Post-LASIKRefinement

Mild Hyperopes(Bilateral CK)

Post-IOLRefinement

Figure 2: Percentage of Practices Using CK by Indication (Multiple responses allowed)

SM2 Survey of CK Surgeons (N=20), June 2005

Page 3: How conductive keratoplasty is impacting the presbyopic practice

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“high maintenance,” these patients are often dealing with visionproblems for the first time in their lives and are unaccustomedto needing any help to function. Our interviews found that theprocess begins with the surgeon and how he views (and ulti-mately presents) his expectations of the procedure.

Surgeons who do best with this procedure are able to sepa-rate CK from LASIK in their minds. Objectively, they feel it isnot as “good” a procedure as LASIK; with a deficiency similarto how hyperopic LASIK is viewed when compared to myopicLASIK. That is, CK does not enjoy the same level of predictabil-ity or stability. However, they recognize this procedure serves adifferent purpose for a different audience. These surgeons areable to view CK in its own right as a solution that fills the gapbetween LASIK and IOLs. While imperfect, it is a solution thatis much better than what all of eye care has been doing for yearsto this audience, namely turning them away and sending themto drug stores for reading glasses.

CK and the Patient EvaluationThere are 3 critical steps in evaluating a patient for CK, and

surgeons were adamant that they cannot be skipped in theprocess.

First, surgeons employ a wide variety of analogies to helpeducate the CK patient, generally focusing around giving backcapability that has been lost. With experience, these surgeonshave determined what words and phrases best describe the pro-cedure and set proper expectations. “The procedure works wellbut you will continue to age,” is a statement that captures thissentiment. Surgeons believe it is essential that patients under-stand that they will be given a “reprieve” until their accom-modative needs increase beyond what can be successfullymanaged via CK.

Second, surgeons ask detailed and probing questions aboutprofession and hobbies. They describe this process as a form of apsychological profile or personality test, looking for indicatorsthat a patient might not be happy with anything less than 100%crisp vision for the distance. Pilots, engineers, attorneys, and thosewho are fanatical golf or tennis players probably won’t toleratewhat they may have to give up at distance to achieve betterunaided vision for near and intermediate. These simply are notgood candidates. However, patients with less demanding visualneeds who express high frustration with reading glasses (example:“these just aren’t for me”) are ideal candidates for CK.

Third, surgeons perform one or more tests to determinecompatibility with a mono- or blended- vision procedure. Allsurgeons employed a loose lens test followed by a contact lenstrial (if doubt persists) for one to two days. The critical decision

CK Patients: How do you find them?

The ideal CK candidate is one who says, “I’ve had greatvision my whole life. I’m only 50 – I’m not old. I’m in theprime of my life and have the money to spend on things thatcan help me. I want to feel better, look younger and performat the top of my game.”

Because they’ve had good vision, many ideal CK patientsare not native to the practice. Nor are they being referred ingreat numbers by optometrists who co-manage, presumablybecause they have not had a strong need for primary eyecare services in their youth and younger adulthood. As withLASIK referrals patterns, word-of-mouth seems to be thedominant means of acquiring patients. This is especially truenow with the LightTouch method, with a greater initial“WOW! Factor” that is helping spur increased referrals.

“You need to make me and my friends aware of what youcan do to help me get rid of these reading glasses, which Ifind truly annoying.”

Advertising and news stories are essential sources of CKpatients, and 16 of the 20 surgeons interviewed conductexternal marketing; they spend an average of $12,650 permonth total on their advertising (range $2,000 to $45,000).This equates to anywhere from 5% – 12% of their monthlyrefractive revenue (one exception is a surgeon who marketsand performs CK as his only refractive procedure; marketingexpenditures are at 30% of revenue).

Most surgeons believe that “cross promotion” of proce-dures in their marketing has been effective. In other words,advertising for CK generates more LASIK business andvice-versa. Further analysis was done by looking at thereported percentage of the marketing and advertising message devoted to CK (as opposed to LASIK, IOLs, orrefractive surgery in general). All but one of the surgeonswho advertise had some portion of their advertising dedi-cated to CK, with a mean of 22% (range 5% to 100%).Comparing advertising dollars invested towards CK to theamount of revenue generated by CK yielded a mean ratio of5.7 to 1. Because the spread of this ratio in this interviewsample is so large (from 1.2 to 13.3), we believe it is moremeaningful to express the average by using the median(3.8) rather than the mean (5.7) value. Using the median,for every dollar spent on CK messaging, an average of$3.80 was generated in CK revenue.

“Reach out and find me today and help me improve myvision. I will stay with you for the rest of my life.”

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point here is whether or not the patient can “psycho adapt” tothe reduction in binocularity, the key factor in predicting thepatient’s likelihood for success with this change in their vision.

Following the CK procedure, successful surgeons employ adifferent protocol for post-op management than is required forLASIK. The initial “WOW! Factor” experienced on the first dayfor near tasks is often followed by a temporary worsening ofdistance vision that lasts from 1 to 2 weeks and graduallyimproves. Thus, the postoperative Day 1 visit is often viewed asa wasted effort as long as the patient is not experiencing someatypical symptom. CK’s safety profile affords this luxury, in con-trast to the post-op requirement for LASIK. However, what CKpost-op management does require is a form of “psychologicalhand holding” that is not generally present with the typicallyyounger LASIK patient. Fortunately, the lack of instant gratifica-tion is well-matched to the more tolerant, more mature patientthat needs CK.

CK As An InvestmentAs with all technology, CK also needs to be measured on its

ability to provide a return on investment for the surgeon. Whatis unique about CK is that there is a three-tier rationale thatneeds to be considered; we will describe these one at a time asfollows and how they support investment into this technology.

1) Positive ROI - Ability to do enough procedure volume topay for the device

At approximately $60,000, the up-front investment for a CKdevice is nominal when compared with a laser (either excimer orfemtosecond), yet has a disposable component of $175 or moreper eye that is roughly equivalent to that charged for use of alaser. Additionally, the time required to perform the procedure isminimal and does not require a special room or dedicated tech-nicians. Some surgeons find it quick enough that they can add itto an existing appointment or squeeze it in, eliminating the needto burden the schedule with CK-specific appointments. A con-servative approach would factor in one-half of a full time equiv-alent employee to assist with the additional hand holdingrequired with CK patients.

The average collected fee per CK treatment among these sur-geons was $1,637 (range: $1,250 to $2,000) and it is typicallyperformed in only one eye. Surgeons who perform a bilateraltreatment (for low hyperopes) tend to charge a discounted feefor the second eye resulting in $2,500 collected OU.

An analysis of the distribution of the number of CK eyestreated during Q1 2005 in this sample follows a normal distri-bution (see Figure 3), with the largest group of surgeons (35%)

doing between 20 and 49 eyes. The mean among all surgeonswas 32.1 eyes for the quarter and the median (half of surgeonsabove, half below) was 18.6 eyes for the quarter. The rangeincludes one surgeon who did not perform CK in Q1 2005 andanother who did 120 CK procedures during the same timeperiod. There was no correlation between high-volume LASIKand high volume CK; both the highest and lowest volume CKsurgeons interviewed were the highest-volume LASIK surgeonsin this sample. Importantly, surgeons also indicated that theirvolumes are increasing at a rapid rate due to the improvedresults from the LightTouch technique.

Using these figures, doing just several eyes per month costjustifies the CK device and all but one of the surgeons inter-viewed met this criteria.

2) Part of the refractive toolkit - Surgeons indicated that CKwas also effective at building other sources of revenue; LASIKprocedure volume benefits from offering CK. This makes senseintuitively when viewed from the perspective of the eye careconsumer. The consumer knows he is bothered by having towear glasses and wants to get rid of them, yet has no clue as towhich vision solution will best meet his needs. News stories oradvertising about any form of visual performance benefit islikely to generate interest from these consumers. Inquiries aboutCK can often lead to a LASIK procedure and vice-versa. it is thesurgeon’s job to properly educate and steer patients to the rightsolution. As a result, all twenty surgeons interviewed believethat CK is an essential tool and would purchase the systemagain if given the choice today.

0

1

2

3

4

5

6

7

0 <10 10 to 19 20 to 49 50 to 75 120

# of CK Eyes

Figure 3: # of CK Eyes Treated Per Quarter (Q1 2005)

Mean = 32.1 eyesMedian = 18.6 eyes

SM2 Survey of CK Surgeons (N=20), June 2005#

of

Pra

ctic

es

Page 5: How conductive keratoplasty is impacting the presbyopic practice

3) Building the patient base - Strategic significance forfuture eye care services

The third rationale, described by several surgeons as key totheir long-term strategy, was the use of CK as a way to begin arelationship with patients that they would not otherwise see foranother 10 to 15 years. Leveraging the less invasive and lessexpensive aspects of the procedure (relative to an IOL), CKallows the surgeon to form a bond with a patient and begin adialog that will continue for many years down the road whenmore invasive and expensive eye care services are needed orrequired. As one physician noted, the reasoning is simple: “If I don’t begin this relationship now, that patient will neverknow I exist and will just as likely choose another surgeon whenit comes time for a cataract or refractive IOL.”

Thus, CK serves as an entry point for the patient into med-ical eye care, and for the surgeon to develop a long-term rela-tionship with that patient.

CK’s Role In The FutureRefractive surgery is a rapidly advancing field, and the future

is filled with other developments, many of which are gearedtowards alleviating presbyopia. These include accommodating,multifocal and phakic IOLs, corneal inlays and onlays, and pres-byopic LASIK. Even with these potentially more advanced devel-opments on the horizon, 80% of surgeons interviewed (16 of20) believe that CK will still be important over the next 3-5years (see Figure 4). This majority is impressed with CK’s safetyprofile and what it offers to patients who are risk averse. Halfof this group (8) believe CK will grow into a “big player” in therefractive field. They view market adoption as only a matter oftime, allowing for growing awareness and acceptance of CK by

both surgeons and their patients. The other half (8) see CKremaining an important “niche player” much as it is today, withits role limited to a step between the full refractive correctionoffered by LASIK for pre-presbyopes and by an IOL for presby-opes both with and without a cataractous lens.

The remaining 20% of surgeons interviewed (4 of 20) feelthat CK will become obsolete once presbyopic LASIK or acorneal inlay becomes available. They are hopeful that a differ-ent solution will provide better predictability with less risk thanan intraocular implant. Admittedly, however, they do not haveenough data to evaluate whether or not a multifocal approachvia ablation or inlay will be good enough in real world clinicalpractice. Only time will tell. While these surgeons are expectingadvancements beyond CK, this is still an important tool in theirrefractive practice today.

SummaryThis survey yielded several key findings that should prove

helpful to surgeons who are considering adopting the technologyas well as current CK users who are looking to expand their useand success with this device:

� Not unlike other eye care technologies such as phacoemulsi-fication or excimer laser ablation, Conductive Keratoplasty hasundergone an evolution in its approach that has refined thetechnique and improved outcomes.

� The patient that is ideal for CK is different than otherpatients currently seen by the ophthalmologist; it will take timeto make them aware of, interested in and educated about CK.This was also true of laser vision correction in its early days.

� Surgeons need to approach CK differently than LASIK.From their own mindset through counseling patients pre- andpost-operatively, the expectations for CK and the managementof those expectations are indeed different.

� The low acquisition cost of the CK device makes it easy tocost justify, with breakeven procedure volumes that are a frac-tion of what is required to breakeven with LASIK. CK has anadditive effect to existing LASIK procedure volume and can beused as a tool to build the future growth of the practice fromadvanced IOLs.

� Even with more advanced technology on the horizon, CK isdestined to have a role within the ophthalmic practice. This is

SM2 Survey of CK Surgeons (N=20), June 2005

Figure 4: Where do you believe CK will be in 3 to 5 years?

Niche Player40%

Obsolete20%Big Player

40%

5

Page 6: How conductive keratoplasty is impacting the presbyopic practice

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largely attributable to its strong safety profile relative to exist-ing and emerging technologies designed for the presbyopicpopulation.

DiscussionTo date, CK has struggled to find where it best fits in the

ophthalmic practice. LightTouch has helped solve some of thisequation, as the improved results from this technique are havinga definite and positive impact on the surgeons’ confidence in theprocedure and willingness to recommend it to patients.

Although many surgeons and industry participants naturallycompare CK to LASIK, that comparison is not truly appropri-ate. While LASIK is a more refined procedure than CK, CK’svalue is in its ability to offer a solution not previously availableand to appeal to those who would never have even considered alaser procedure. LASIK has been so dominant in part because ithas and likely will continue to be the best solution for myopia.CK addresses a different problem – presbyopia - one that ismuch more difficult to solve.

LightTouch has changed the dynamic of this process and cre-ated a positive cycle that was previously broken by the wide-ranging results of the original technique. Better outcomes lead tofewer post-op issues (under response, induced cylinder, need toenhance), which leads to a happier patient and a more confidentsurgeon. Patient and surgeon are then working in tandem topositively promote the procedure and attract future patients.

The intent of this research was to understand the benefitsand barriers to adoption of CK within the practice. The clinicalresults from CK are sufficient to justify the investment, one thatpays off both today and in the future. Surgeons who have suc-cessfully integrated CK in their practice believe that creating arelationship with this new group of patients now solidifies theirposition to provide more services for them in the future. CKoffers a means to building a high trust level with patients.Given future trends in ophthalmology, we view this to be a mostcompelling reason to get involved with the technology.

In short, CK should be viewed as an essential tool in therefractive armamentarium if the practice is willing to reach acurrently under-served patient base.

© Copyright 2005, SM2 Consulting. All rights reserved.