P R O C E E D I N G S

Time: 9:37 a.m.

CHAIRMAN WEISS: I would like to call this meeting of the Ophthalmic Devices Panel to order. We have a quorum present, and we will have introductory remarks by Sally Thornton.

MS. THORNTON: Sorry for the delay. Excuse me, please. Is Sandy Berman in the room?

CHAIRMAN WEISS: With a little bit of a delay for the usual introductory remarks Sally will make. So in the interest of time, what I will do is read you a financial disclosure comment that is required by the agency, and this will be in preparation for those of you who will be participating in the Open Public Hearing.

Both the Food and Drug Administration and the public believe in a transparent process for information gathering and decision making. To ensure such transparency at the Open Public Hearing session of the Advisory Committee meeting, FDA believes that it is important to understand the context of the individual's presentation.

For this reason, FDA encourages you, the Open Public Hearing speaker, at the beginning of your written or oral statement to advise the Committee of any financial relationship that you may have with the sponsor, its product and, if known, is direct competitors.

For example, this financial information may include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at the meeting. Likewise, FDA encourages you at the beginning of your statement to advise the Committee if you do not have such financial relationships. If you choose not to address the issue of financial relationships at the beginning of your statement, it will not preclude the Public Hearing speaker from speaking.

I will remind those of you who are speaking for sponsor, when you do come to the podium, aside from identifying yourself and giving your relationship with the sponsor, you also are required to disclose any financial relationships you may have.

If you can just remain in your seats, we will sort of take an informal break for a few minutes until we have the necessary information here. So you can talk among yourselves.

We will go out of order. As long as I have given the introductory statement for the Open Public Hearing, we will start with the Open Public Hearing. In interest of the 30 minutes that we have for this section, on each of the speakers we will have no more than seven minutes.

The first speaker is Mr. Glenn Hagele of the Council for Refractive Surgery Quality Assurance.

MR. HAGELE: Good morning, and thank you for the opportunity to address this Panel. My name is Glenn Hagele. I am the Executive Director and Founder of the Council for Refractive Surgery Quality Assurance which, from this point forward I will refer to by its acronym, CRSQA.

I have no financial interest in Refractec. My travel here is self-funded, and do not necessarily -- Sorry, I missed my notes. The comments that I make here are my own and not necessarily those of anyone affiliated with the Council for Refractive Surgery Quality Assurance.

CRSQA is a nonprofit consumer patient organization, and through its sister websites, USAEyes.org and ComplicatedEyes.org, receives over 800,000 visitors annually. We provide objective information about refractive surgery issues and resources for those unfortunate few who have encountered poor refractive surgery outcomes.

Additionally, CRSQA evaluates and certifies refractive surgeons based upon patient outcomes. In addition to research of public studies and case reports, my interaction with patients provides me with a unique accumulation of anecdotal information and the perspective of a patient.

The issues and concerns that I will raise today all relate to communications between physician and patient.

I wish to commend the sponsor for investing the time and money in seeking FDA approval of conductive keratoplasty for monovision correction. CK monovision is currently an appropriate off-label use of the approved device under scope of practice rules.

Seeking FDA approval for monovision correction is not a requirement. Yet sponsor has decided to subject itself to the rigors of the approval process. No matter what the final decision of this Panel regarding approval, the company should be recognized for this commitment.

While it could be argued that the motivation for seeking approval of CK monovision is primarily for purposes of marketing, that opinion would overlook the important asset that will be afforded the public by sponsor's decision to seek approval, the safety and efficacy data that will be evaluated by this panel, which will, of course, help patients make an informed consent.

Plano presbyopes seeking relief from the need for reading glasses inundate our organization with requests for information about techniques and technologies to rid themselves of what many consider a tolerable inconvenience. As you can see, I am sliding my glasses down to be able to see these papers.

Although we may be able to provide limited information about monovision correction with contacts, LASIK and other forms of refractive surgery, the information presented to this Panel by sponsor will provide prospective patients with hard data that they seek to be able to make an informed decision about CK monovision.

Something about the terminology that will be used will be really important. CK monovision is not a cure for presbyopia. Accommodation will not be restored. There will be no functional change to the crystalline lens.

For this reason, I am hopeful the language used in this labeling will reflect that CK monovision is a surgical process that attempts to compensate for the effects of presbyopia. It is not a cure.

It is very important that patients understand this difference, and I suggest that labeling reflect that presbyopia remains, even if CK monovision compensates for presbyopia's effects.

Regarding the learning curve, today you are going to see results from what can only be described as some of the best surgeons in the world. It is reasonable to assume that not every surgeon will be of the same caliber.

I have no reason to doubt that sponsor will provide significant training, and I am certain that this panel will insist on adequate training or proctoring. I believe, however, that it is in the best interest of the patient to be informed of the practical experience of the prospective surgeon.

From the results I have seen through direct patient interaction, it appears that the probability of successful outcome with CK for hyperopia is significantly dependent upon the surgeon's practical experience. Although we have received relatively few patient complaints regarding CK for hyperopia, they have been primarily from patients whose surgeons had limited CK experience.

I will quickly add that the sponsor was very responsive to our expressed concerns in these instances, but I will discuss that later.

Our organization provides a list of 50 tough questions for your doctor for patients to use as a guide in selecting their refractive surgeon. In our 50 tough questions we recommend that a patient seek a doctor who has performed at least 100 refractive surgeries of exact type intended to be used on the patient with the same equipment, the same refractive error, and significantly more practical experience with similar surgical techniques.

While this panel may find our recommendation of 100 a bit conservative and even restrictive, it does seem reasonable to assume that the patient would like to know if he or she is the doctor's first unsupervised CK monovision patient.

I respectfully request that this Panel include in the patient labeling an indication that training and practical experience of the surgeon may be an important factor in the probability of a desirable outcome.

Determining which eye is dominant and, thereby, which eye would receive CK monovision is an important factor in the success of the monovision effect. Surprisingly, I have found that a single best method for determination of dominant eye is not currently established in ophthalmology.

If I ask 10 doctors how to determine which is the dominant eye, I will receive six different answers, from asking which hand the patient writes with to having the patient hold a camera up to see which eye the patient uses to look through the viewfinder, to tossing an object at a patient to see which hand they use to catch it.

In researching the most appropriate technique to help advise patients on how to determine their dominant eye, I sought the counsel of those individuals who be very negatively affected if they did not use the correct eye as dominant, including SWAT team sharpshooters, hunters and, ultimately, members of the U.S. Olympic archery team. I can assure you that the members of the U.S. Olympic archery team do not throw objects at each other to determine eye dominance.

I do not wish to be so presumptuous as to suggest to this Panel the technique for determination of eye dominance that is considered most accurate by these other groups, but I do respectfully request that the labeling for the physician include an appropriate technique and subsequent information.

CK is currently approved as a temporary correction for hyperopia. This decision to approve CK as a temporary correction was predicated on CK's rate of regression. This is a very important consideration for a patient considering CK monovision, because it creates a unique situation after surgery.

If the patient, for any reason, decides after CK monovision that he or she does not like the monovision effect, surgical corrective measures are probably not appropriate.

If a myope has LASIK in one eye and one eye undercorrected for the monovision effect, then decides that he or she does not like the effect, additional LASIK enhancement surgery would be appropriate, because both the primary and the secondary procedures are permanent.

If the patient has CK monovision and--

CHAIRMAN WEISS: Excuse me, Mr. Hagele. I think you have had your seven minutes, and your time is up. I thank you for your comments.

We are going to go on to Dr. Milne. If I am mispronouncing your name, I apologize. In interest of time and the agenda, we are sticking to the allotted time. So just keep it in mind.

DR. MILNE: Thank you, and "Mill-ne" is correct. The Scots say "Miln," but "Mill-ne" is the way we say it over here.

CHAIRMAN WEISS: Good.

DR. MILNE: My name is Rick Milne. I am general ophthalmologist in Columbia, South Carolina. I am not a paid consultant of Refractec, and I had to pay my way here today and was glad to get here last night through all the winter weather.

I am here because I have a sincere desire to see CK approved for the correcting of -- or the recovery of near-vision in the presbyopic patient.

I have performed over the last two years over 800 CK procedures in my practice. I have a general ophthalmology practice that does more cataract surgery than refractive surgery.

Interesting, over the last year over 80 percent of the patients I am doing CK on are having the procedure for the off-label use of regaining their near vision, and they are presbyopic. That seems to be the true niche and the true great benefit this procedure is bringing to my patients.

Now I am speaking not only as a provider of CK, but I am also speaking as a 47-year-old microsurgeon who has chosen to have CK to recover my near vision. I had CK about two months ago. Pre-CK I was a +.65 hyperope, and I was Jaeger 10 vision, and my life had become quite frustrating.

As an ophthalmologist, we go from a slit lamp to chart work, speaking to patients. Reading glasses were not a very good option for me there, and also contact lens wear -- I did try the monovision contact lens, and I have basically genetically dry eyes. My father had dry eyes. I have dry eyes, and really, contact lens wear was uncomfortable to me and something that was just really not very doable for me.

So I chose CK. It is interesting. Maybe it is because I am now a 47-year-old presbyope or maybe it is because there's so many baby boomers who are becoming presbyopic, but over the last several years I have really noticed how frustrated our society and how intolerant our society is becoming over presbyopia.

I will give you one example. A few weeks ago I was traveling and was in a Hertz van in the late evening, and I was in a van full of a bunch of presbyopes, and we were heading out to get our cars, and everyone had their Gold Medallion car selections. So the manifesto was passed around so people could see where their car was parked.

Well, our driver was a presbyope. All of our people in the van were presbyope, and person after person cannot read to find out where their car manifesto was. To tell you the van was getting frustrated is a minor statement. You know, it was a long travel, and there was a lot of anxiety going on there.

Finally, there was one presbyopic myope that took his glasses off and read the manifesto for everyone. Interestingly, I had had CK and I was just quietly waiting for my time to see the manifesto to help people. I didn't want to be braggadocious or anything. But anyway, of interest, my wife leaned forward. She was sitting across from me, and she learned forward and she looked at me, and she said something very profound. She said, "You could help these people."

You know what? She had it exactly right. I had personally come to realize that presbyopia is really quite disabling in a lot of situations, and there really is a need to help people.

Also just in general in our culture, I don't know if you have seen the movie, "Something's Got to Give," where Jack Nicholson and Diane Keaton play a great role. But that movie identifies two things of becoming aged and infirm.

The one is Jack's need for Viagra, and the other is both he and Diane's need for reading glasses, over and over again throughout the movie. It was portrayed in a way that most of us baby boomers don't like to be portrayed. So it is something baby boomers -- we are definitely frustrated with our situation, and we are looking for good options.

It has been interesting. I chose CK for a number of reasons, and I find my patients choose it for the same reasons. Number one, the option of reading glasses, as I said, were not a good option. Contact lens were not a good option for me, and a lot of patients over the age of 40-45 are beginning to have problems with their tear functioning.

I found the procedure to be a very safe procedure after doing it on 800 people. Even now, looking through the literature, and I will call John Hayashida from time to time to make sure I am correct about this, there has not been one serious complication from CK worldwide to this date.

Now as a microsurgeon who makes my living needing to see things with fine detail, I wanted a very safe procedure. I wanted one where I was not taking a risk, because I lose a few lines of vision and I don't get to do what I do and my family is very unhappy with me. But I chose it, and I'm very glad I did.

Also of interest, the stability of my patients, anecdotally -- I have not had one patient in two years have to return and say, you know, I'm beginning to lose the effect of this. I'm hoping, if I get five to ten years from this procedure, I'll be thrilled. At that time I may need something else down the road; maybe not. We may find this to be quite stable.

In fact, just as another anecdote, my hyperopic LASIK patients, I find that they seem to have more regression than this procedure does, just anecdotally.

So I am thrilled with my CK procedure. I am thrilled with what it has done for me. I am very thrilled with what it has done for my patients. I have a lot of happy people out there, and I would highly recommend you to approve CK for the recovery of near vision in the frustrated presbyopic patient. Thank you very much.

CHAIRMAN WEISS: Thank you very much. Barbara Jo Morley.

MS. MORLEY: Good morning. My name is Barbara Morley, and I am from Overland Park, Kansas. I am a teacher by education and a homemaker, and I have come here today as a recipient of the keratoplasty monovision procedure.

My mother once said to me that, be thankful you have long arms, because they will come in handy one day. And they did, I found out, because the older I got, the further away I had to hold my piece of paper to read it. But eventually my arms were not long enough.

So I resorted to other measures like buying glasses at WalMart, and I had them in every room in the house, bathroom, kitchen, bedroom and, then when I couldn't find mine, I would use my husband's, because he had the same problem.

As an educator, I tutor now out of my home, and I tutor on an individual basis. So I was constantly having to put my glasses on to see the text of the students, and then take my glasses off to actually talk to the student. I'm sure that was very distracting for the student, as it was for me.

I also lead a Bible study with a group of 16 women, and the Bible that I have is very small print, and I would be doing the same thing, reading the verses in the Bible, taking my glasses off to speak to the ladies in the group, and putting them back on. It came to be quite the joke.

At a certain point when you can't find the glasses, when you are tired of doing that, you look to other options. About the first time that I thought that I needed to have something done was -- Really, it wasn't a funny situation. It was dangerous.

I had been on Mapquest, and I needed to go to a place, and I didn't know how to get there. So I printed the directions out, and as I was driving to the place, I don't drive with my glasses, but I actually needed my glasses to read what the Mapquest said.

So I thought this is dangerous. So I had to pull over to the side of the road and read the directions and then get back on the road, and remember the directions, which is a whole 'nother problem, to get where I was going. I thought that's just not good.

I have never worn glasses before. I have always had perfect vision. So it was hard for me to identify people with glasses. So what's the big deal. But as I aged and I saw it was a big deal, especially when you only need them a portion of the time.

So at that point, my husband had had eye surgery, but he had had not had this eye surgery. So I was familiar with the clinic, the Hunkeler Eye Clinic in Overland Park, and was presented with the opportunity to have this done.

I am not a person who takes risks at all, although you wouldn't believe that if you heard the story of how we got here. But I decided that I wasn't liking my lifestyle as it was. It was too much of a hassle and, if there was something that I could have done that would eliminate that, that I would be willing to do that.

I did a lot of reading that was presented to me by the clinic, and talked to several people and Dr. Durrie has an awesome reputation in our city. So I decided that I would do that.

The procedure itself takes such a minuscule amount of time. I think I was in the chair and out of the chair in less than five minutes. There was no pain at all associated with the procedure. I was able to read immediately afterwards when they took me into the little recovery room there, and they gave me the after-procedures that I would need to do. I could read the sheet right away. So there was no time to adjust.

The only inconvenience of the surgery itself was -- I think it was after the numbness, the anesthetic, wore off that your eye feels like it has sand in it or a little gritty for about a day. Then after that, it's fine.

I had the surgery -- it will be two years this August, and I can still read the phone book. I have thrown all the glasses away in my house. That's how confident I am. It has been a huge blessing to me and my lifestyle for that.

Just to end, Charlene, the other lady and I that came together to testify -- We feel so blessed that we had this that we were sitting in the Kansas City airport when the flight that we were supposed to take to come here ran off the runway. So they came on and they say, Flight 5454 is no longer in existence.

So Charlene and I sat there and, you know, what do we do now. But we were determined to come and speak with you, because we are both so thankful for this procedure.

My affiliation with the sponsor is none other than they did pay my travel expenses here. However, I think they still owe me, because that was some harrowing trip. Thank you very much.

CHAIRMAN WEISS: Well, you can do your negotiations with the sponsor. Charlene Myers. Thank you.

MS. MYERS: Hi. I am Charlene Myers, and I am from Kansas City, Kansas. I just want to say that -- I'm very nervous -- that I had the procedure done about -- It will be three years in August, and I have been absolutely thrilled with it.

My job -- I work in the travel industry, and I have to read the computer a lot, and I have to read a lot of tickets and a lot of papers, and it is frustrating when you have to take your glasses off and on to be able to look at someone, that they are not blurred. Then you have to tote them on to be able to read. So that was an absolutely wonderful thing there. I can also read to my grandchildren without my glasses, which is even better.

How I got into it was two of my daughters had surgery, but for a different type of vision. They made a comment, saying that it's too bad they didn't have something for you to be able to read better. Well, they were speaking to someone there at the clinic, and they did say there was.

So I went in and was, I guess you might say, a candidate. So I did the procedure, which was very scary, but I did it, and I am so happy that I did.

I really don't know what else to say except it's just absolutely wonderful, and I would recommend it to anyone to have done if they cannot read without having glasses. Thank you.

CHAIRMAN WEISS: Thank you very much. Your sincerity overweighed your nervousness.

Are there any other speakers for the open public hearing? If not, the open public hearing portion is closed.

We will now have introductory remarks by -- or semi-introductory remarks by Sally Thornton before we go on to the open committee session.

MS. THORNTON: I would like to read at this time the conflict of interest statement for this date.

The following announcement addresses conflict of interest issues associated with this meeting and is made part of the record to preclude even the appearance of an impropriety. To determine if any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.

The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. The agency has determined, however, that the participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved, is in the best interest of the government.

Therefore, waivers have been granted for Doctors Michael Grimmett, Oliver Schein, and Woodford Van Meter for their interest in firms that could potentially be affected by the Panel's recommendations.

Dr. Grimmett's waiver involves a past imputed interest, a grant to his institution for the sponsor's device, which is not the subject of this meeting. He had no involvement and received no compensation.

Dr. Oliver Schein's waiver involves two consulting arrangements, one pending for a competitor's unrelated device for which he had not received any compensation, and the second with a competitor's unrelated device for which he receives an annual fee between $10,000 and $50,000.

Dr. Van Meter's waiver involves an imputed interest, a stockholding in the parent of a competing technology firm in which the value is greater than $100,000.

The waivers allow these individuals to participate fully in today's deliberations. Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

We would like to note for the record that the agency took into consideration other matters regarding Doctors Anne Coleman, Arthur Bradley, Michael Grimmett, Andrew Huang, Marian Macsai-Kaplan, Oliver Schein, and Jayne Weiss. Each of these panelists reported past or current interests involving firms at issue, but in matters that are not related to today's agenda. The agency has determined, therefore, that the panelists may participate fully in all discussions.

In the event that the discussion involves any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement, and the exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon.

Thank you, Jayne.

CHAIRMAN WEISS: Thank you. With that, we will open the Open Committee Session for PMA P010018/S005. The sponsor can come to the podium. You have one hour for your presentation. If you can please identify yourself when you speak into the microphone, what your relationship to the sponsor is, and any financial interests you have in the company or any other financial relationship you have with the sponsor.

DR. HAYASHIDA: Good morning. My name is Dr. Jon Hayashida, Vice President of Clinical Affairs for Refractec.

I have the pleasure of introducing for consideration by this Panel our pre-market application, P010018 Supplement 5 for the ViewPoint CK System used for the improvement of near vision in presbyopes.

I will be joined by Dr. Mark Bullimore who will present some background information on monovision, and Doctors Marguerite McDonald and Dan Durrie, clinical investigators in the PMA clinical trial. Dr. Judy Gordon will facilitate our discussion in response to questions from the Panel.

Please note that Doctors Bullimore, Durrie, Gordon and McDonald are paid consultants to Refractec.

We appreciate the opportunity to present to this Panel and hope that our presentation elucidates the clinical data presented in this PMA.

I will begin our presentation with a brief discussion of the indication for use. The ViewPoint CK System indicated for the temporary treatment of hyperopia was approved by the FDA in April 2002. Since that time, approximately 25,000 cases of conductive keratoplasty have been performed in the U.S., and to date the safety profile of the procedure has been excellent.

The subject of the current PMA being considered by this Panel is the use of the ViewPoint CK System for the temporary induction of myopia, from -1.00 to -2.00 diopters, for improvement of near vision in the non-dominant eye of presbyopic hyperopes and presbyopic emmetropes with a successful preoperative trial of monovision or history of monovision wear.

The improvement in near vision is provided by the clinical technique of monovision in which the non-dominant eye is targeted for a myopic endpoint, and the dominant eye provides distance vision.

To present some pertinent background on monovision, I would now like to introduce Dr. Mark Bullimore.

DR. BULLIMORE: Thank you, Jon. Good morning, ladies and gentlemen. My name is Dr. Mark Bullimore, and as previously mentioned, I am paid consultant to Refractec.

Now the clinical technique of monovision is widely accepted and has a long history of use. In their comprehensive 1966 review, Jain and colleagues concluded that monovision is an effective and reasonable therapeutic modality for correcting presbyopia. They also noted that proper patient selection and clinical screening are essential for monovision success.

Currently, monovision may b achieved in our practices by means of contact lenses, intraocular lenses or refractive techniques such as PRK or LASIK.

Nonetheless, monovision is not without its limitations. Even in satisfied, successful monovision patients, it is common to find decreased contrast sensitivity and reduced stereopsis in selected patients, and this is, of course, due to the monocular blur.

It has also been widely reported in the published literature that patients can experience glare and other night vision difficulties. There are also a few case series and case reports of patients having more severe binocular vision anomalies associated with monovision.

Now these monovision related issues serve to emphasize the need to balance good near visual acuity with maintenance of comfortable binocular vision. In essence, the goal or the challenge is to provide or to attain some intraocular blur suppression. It is well known that the quality of this suppression is associated with a number of factors, in particular, the magnitude of the reading addition.

Now a number of factors contribute to a successful monovision patient. Careful pre-screening of patients is important, along with a contact lens monovision trial or a history of successful monovision contact lens wear.

As mentioned previously, it is important to maintain an appropriate level of binocularity, and this can be achieved by limiting the add power. It has been documented that add powers higher than 1.5 to 2.0 diopters can result in a loss of binocular summation and associated problems.

Finally, patient education is critical. Patients need to understand, of course, that monovision is a compromise between distance vision and near vision. There are potential for symptoms well documented and, most importantly, there may be a need for continued spectacle use, even though, hopefully, in a successful monovision patient, that dependence on spectacles would be substantially reduced.

At this point, I would like to introduce Dr. Marguerite McDonald who will describe the technology and begin the presentation of our clinical trials results.

DR. McDONALD: Good morning. I am Dr. Marguerite McDonald, and I am going to first present information on the ViewPoint CK System, then describe the study design and review the safety results.

Monovision treatment performed with conductive keratoplasty or CK is the same procedure as was approved for hyperopia treatment, using the same device, same energy, same spot pattern and the same range of correction, but with a refractive target of -1.00 to -2.00 diopters.

As shown in this photograph, the ViewPoint CK System consists of a portable console that generates the radiofrequency energy, a lid speculum and a handpiece in which a small tip called the Keratoplast Tip is held. The Keratoplast Tip is used to deliver the energy for treatment, while the lid speculum serves as the return.

CK involves the controlled intra-stromal delivery of radiofrequency energy to a depth of approximately 500 microns in the corneal periphery. Radiofrequency energy passes from a generator to a probe tip into the corneal stroma, and returns via the lid speculum. This provides a homogeneous and uniform cylinder of optimally constricted collagen to a depth of approximately 80 percent of the peripheral corneal thickness.

The CK treatment applications are of constant power, with an increase in the number of rings of applications to achieve greater levels of corneal steepening. The procedure spares the visual axis, offering an important potential safety feature. Application of treatment spots in a circular pattern at fixed radii results in steepening of the central cornea with a range of correction from +0.75 to +3.00 diopters, since some patients required up to 3.00 diopters of intended change to reach a refractive target of -2.00 diopters.

As shown, the optical zone marks of 6, 7 and 8 millimeters act as a template for the treatment application. Once the optical zone marks are applied, the surgeon begins applying treatment spots until all of the rings of treatment are complete, resulting in steepening of the central cornea.

I will now present the study design and the safety results for the prospective multi-center clinical trial of the ViewPoint CK System for improvement of near vision in presbyopes.

The clinical trial that is the subject of our PMA was conducted at five clinical sites with investigators who are experienced refractive surgeons. All but one of the study investigators participated in the hyperopia clinical trial of CK.

The study protocol called for enrollment of 150 consecutive subjects who met all eligibility criteria. To enroll in the study, prospective candidates were required to be presbyopes at least 40 years of age, requiring a near add of +1.00 to +2.00 diopters.

Hyperopes with cycloplegic refraction spherical equivalence of up to +2.00 diopters and emmetropes were eligible for enrollment. Patients were required to be successful monovision contact lens wears prior to enrollment or to successfully complete a contact lens monovision trial.

To this end, a documented history of successful contact lens monovision or a successful contact lens monovision trial was required. A contact lens monovision trial lasting an average of one week was conducted to carefully screen patients with no prior monovision experience.

The treatment goal in this study was to improve near vision by targeting a myopic endpoint of -1.00 to -2.00 diopters in the non-dominant eye. Distance vision was provided by the patient's dominant eye. It should be noted that, because this study was initiated prior to approval of the CK procedure for hyperopia, dominant eyes of presbyopic hyperopes requiring distance correction were enrolled and treated under the study protocol.

The target correction for the non-dominant eye was determined by first performing a subjective refraction with add determination. This was followed by addition of plus lenses until the best clarity was achieved at 14 inches.

Patients had the option of selecting a partial near correction to meet individual preferences for near vision, such as reading or computer work, to ensure clinically acceptable anisometropia, the refractive target was limited to -2.00 diopters.

Safety parameters included measurement of best correct visual acuity, induced cylinder, contrast sensitivity, patient symptoms, and as for any clinical trial, complications and adverse events.

Following the CK procedure, all FDA limits for safety with regard to preservation of best corrected distance acuity were met in the study population. No more than one percent of eyes lost more than two lines of best corrected distance acuity at anytime during the course of the study, and no eyes were worse than 20/40 post-operatively.

The key effectiveness parameters in this clinical trial of CK for improvement in near vision are the same as those reported for all refractive surgery studies, but with a primary endpoint of improvement in uncorrected near acuity rather than uncorrected distance acuity.

The data we will be presenting differ from the standard refractive surgery outcomes in that we will be presenting monocular and binocular, uncorrected near acuity, as well as combined uncorrected distance and near acuity.

Please note that in this summary of effectiveness parameters 14 eyes treated for uncorrected near acuity at distances greater than 14 inches are excluded. As you can see from this slide, FDA targets for predictability of the refractive outcome are approximated or exceeded at all follow-up intervals.

The improvement in uncorrected near acuity from baseline is particularly impressive when considering that only five percent of eyes were J3 or better preoperatively, and this increased to approximately 80 percent after treatment with CK.

Clinical results: A total of 188 eyes of 150 subjects were enrolled in this study, and demographic information for the study population is shown here. Consistent with other clinical trials of refractive surgery procedures, a larger number of women than men were enrolled. However, this is a slightly older population with a mean age of approximately 53 years.

As mentioned earlier in our presentation, the study population included 38 hyperopic eyes treated for distance. These eyes were included in the study protocol, since the study was initiated prior to approval of the hyperopia PMA. However, since the results of these distance corrections were consistent with the approved PMA outcomes, they will not be discussed further.

Accountability in the study was excellent, with 97 percent of all eyes enrolled available for analysis at six months. This level of accountability and availability for analysis was discussed with FDA prior to submission of the PMA, and is consistent with the data presented in the approved hyperopia PMA.