James P. McCulley, md, Chair




НазваниеJames P. McCulley, md, Chair
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PARTICIPANTS


James P. McCulley, MD, Chair

Mark A. Bullimore, MCOptom, PhD

Eve J. Higginbotham, MD

Marian S. Macsai, MD

Joel Sugar, MD

Jose S. Pulido, MD

Janice M. Jurkus, OD

Woodford S. Van Meter, MD

Alice Y. Matoba, MD

Frederick Ferris, MD

Ming X. Wang, MD, PhD

Mark J. Mannis, MD, FACS

Lynn Morris

Marcia S. Yaross, PhD


FDA PARTICIPANTS

Sara M. Thornton, Executive Secretary

A. Ralph Rosenthal, MD

Morris Waxler, PhD

CONTENTS


PAGE


OPEN SESSION


Call to order - James P. McCulley, MD, Chair 1

Introductory Remarks - Sara M. Thornton, Exec. Sec. 1

Conflict of Interest Statement 4

Appointment to Temporary Voting Status 5


OPEN PUBLIC HEARING 6


Karl G. Stonecipher, MD 7

Peter N. Arrowsmith, MD 13

Keith Liang, MD 17


OPEN COMMITTEE DISCUSSION - James P. McCulley,MD, Chair 28


PMA P990010

SPONSOR PRESENTATION

J. Charles Casebeer, MD 32

Guy M. Kezirian, MD 35


FDA PRESENTATION

Morris Waxler, PhD, Chief, Diagnostic and Surgical

Devices Branch 57

Jan C. Callaway, PMA Team Leader 57


Clinical Review: Bernard P. Lepri, OD, MS, M.Ed 58


COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Mark J. Mannis, MD 74

Mark A. Bullimore, MCOptom,PhD 78


PANEL DISCUSSION 83


30-MINUTE OPEN PUBLIC HEARING SESSION 162


FDA CLOSING COMMENTS 165

SPONSOR CLOSING COMMENTS 165


Voting Options Read 168


PANEL RECOMMENDATION TAKEN BY VOTE 169

POLLING OF PANEL VOTES 183

CONCLUDING REMARKS 186


CONTENTS (CONT'D)


OPEN COMMITTEE DISCUSSON PERIOD (Continued)


PMA980051

SPONSOR PRESENTATION

Douglas D. Koch, M.D. 187

R. Doyle Stulting, M.D., Ph.D.

Till Anschuetz


FDA PRESENTATION

Morris Waxler, Ph.D., chief, Diagnostic and 232

Surgical Devices Branch

Everette T. Beers, Ph.D., PMA Leader


CLINICAL REVIEW

Malvina B. Eydelman, M.D. 233


COMMITTEE DELIVERATIONS

Primary Panel Reviewers:

Marian S. Macsai, M.D. 250

Michael R. Grimmett, M.D. 258


Open Public Hearing Session 289


FDA Closing Comments 291


Sponsor Closing Comments 291

P R O C E E D I N G S 8:13 AM

DR. MC CULLEY: I will call the meeting to order. I would like to turn the floor to Ms. Thornton.

MS. THORNTON: Good morning, and I would like to welcome all the attendees. Before we begin with today's agenda, I have a few short announcements to make. I would like to remind everyone that you are requested to sign in on the attendance sheets in the registration area just outside the meeting room.

You may pick up an agenda and information about today's meeting, as well as tomorrow's meeting and how to obtain summary minutes or Panel transcripts. You should make a note that there is a Panel meeting tentatively scheduled for September 23, 1999.

Information will be on our web site as soon as it can be put up. Messages for Panel members and FDA participants, information or special needs should be directed through Ms. Amory Williams or Ms. Theresa Lewis who are available at the registration table.

For those of you with cell phones and pagers we ask that you turn them off or put them in the vibration mode. Lastly, will, not exactly lastly, will all meeting participants please speak into the microphone and give your name clearly so that the transcriber will have an accurate recording of your comments.

For those of you who will be making presentations at the presentation table, this includes FDA staff, there are name tents on the tables. You cannot see them, but pick out whatever name you like and put it up when you prepare to make your presentation.

There will be possibly if time allows some network news filming during the open public hearing portion of the meeting and possibly a little bit further into the meeting. I just wanted you to be aware of that, and now, I would like to extend a special welcome to the Panel and to express FDA's appreciation to them for the time they have taken from their busy schedules to prepare for this meeting. This has been a pretty hefty load of documents for everyone to go through, and they have all done very well, I am sure, and I really want to thank them for the effort that they put forth to prepare for us today.

I would like to have the Panel now introduce themselves for the record, beginning with Dr. Marcia Yaross.

DR. YAROSS: Marcia Yaross. I am director of regulatory affairs at Allergan in Irvine, California and industry representative to the Panel.

MS. MORRIS: I am Lynn Morris, California State Department of Consumer Affairs, Deputy Director.

DR. FERRIS: I am Frederick Ferris, Director, Division of Biometry and Epidemiology, National Eye Institute.

DR. VAN METER: Woody Van Meter, private practice in cornea and external disease in Lexington, Kentucky.

DR. MACSAI: Marian Macsai, professor of ophthalmology, West Virginia University School of Medicine.

DR. JURKUS: Jan Jurkus, professor of optometry, Illinois College of Optometry.

DR. HIGGINBOTHAM: Eve Higginbotham, professor and chair, Department of Ophthalmology, University of Maryland, School of Medicine.

DR. PULIDO: Jose Pulido, professor and head, Department of Ophthalmology, University of Illinois.

DR. MC CULLEY: Jim McCulley, professor and chairman, University of Texas, Southwestern Medical School.

DR. SUGAR: Joel Sugar, professor of ophthalmology, University of Illinois, Chicago.

DR. BULLIMORE: Mark Bullimore, associate professor, Ohio State University, College of Optometry.

DR. MATOBA: Alice Matoba, associate professor of ophthalmology, Baylor College of Medicine.

DR. MANNIS: Mark Mannis, professor of ophthalmology, University of California, Davis.

DR. WANG: Ming Wang, Director of Refractive Surgery, Vanderbilt University.

DR. ROSENTHAL: Ralph Rosenthal, Division Director, Division of Ophthalmic Devices.

MS. THORNTON: Thank you, everyone. I would like to now read the conflict of interest statement for the Ophthalmic Devices Panel meeting for July 22. The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude even the appearance of an impropriety.

To determine if any conflict existed the agency reviewed the submitted agenda and all financial interests reported by the committee participants. The conflict of interest statute prohibits special government employees from participating in matters that could affect their or their employer's financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved is in the best interests of the government.

A waiver has been granted for Dr. Ming Wang for his interest in a firm that could potentially be affected by the Panel's deliberations. Copies of this waiver 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 certain matters regarding Drs. Mark Bullimore, Frederick Ferris, Janice Jurkus, Marian Macsai, Mark Mannis and Ming Wang. These individuals reported past and/or current interest in firms at issue but in matters not related to today's agenda.

Therefore the agency has determined that they may fully participate today. The agency, also, considered Dr. Michael Grimmet and Dr. Mark Mannis' reported involvement related to vision correction. In the absence of any financial interests the agency has determined that they may participate fully in today's deliberations.

In the event that the discussions involve any other product 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 interests 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, and I would like to now read the appointment to temporary voting status for today's meeting. Pursuant to the authority granted under the Medical Devices Advisory Committee charter dated October 27, 1990, as amended April 20, 1995 and October 10, 1997, I appoint the following individuals as voting members of the Ophthalmic Devices Panel for the duration of this meeting on July 22, 1999, Drs. Frederick Ferris, Mark Mannis, Woodford Van Meter, Alice Matoba, Ming Wang.

I, also, appoint Dr. Michael Grimmett as a voting member of the Panel for the discussion of the homium(?) laser for the correction of hyperopia. For the record these persons are special government employees and are consultants to this Panel or consultants or voting members of another Panel under the Medical Devices Advisory Committee. They have undergone the customary conflict of interest review and have reviewed the material to be considered at this meeting. This appointment order was signed by Dr. David W. Feigel Jr., Director of the Center for Devices and Radiological Health, July 21, 1999.

Thank you, Dr. McCulley.

DR. MC CULLEY: We will now begin the open public hearing. This is a 30-minute session. There have been three individuals who have stated prior to the meeting that they wished to speak and have been allotted time. Time allowing in this 30-minute session, others will be recognized to speak. I am not allowing, I will make note for you that there will be another 30-minute session for open public hearing near the end of the Panel's deliberations. So, the clock will be running.

Each of the individuals who has been allotted time has been allotted 10 minutes maximum.

Dr. Stonecipher?

Please identify yourself and any interests, financial interests, ties that you might have?

DR. STONECIPHER: Good morning. I am Dr. Carl Stonecipher. I feel very honored to have this opportunity to speak before this Panel with regard to data for laser in situ keratomileusis. It has been a pleasure to work with this group of individuals over the past 3 years and finally see these endeavors come to fruition. I have no vested interest in either the company's laser technologies that we are looking at nor other industry-related conflicts that I think would interfere with my presentation to this Panel.

I do serve as a clinical adviser to Laser Vision Center's, but I am not currently paid consulting fees from them other than travel reimbursement to and from meetings regarding those consultations.

I have been associated with refractive surgery since its inception in the US with the National Eye Institute's initial radial keratotomy trials. As a medical student, I helped collect data for these trials for one of the investigators. I have had the opportunity to work with the Excimer laser starting with bench-top models back in the late eighties. I was first exposed to the VISX and Summit lasers in clinical trials in the late eighties as well. I have participated in a peripheral role in data collection for these trials, as well as watched these lasers come to approval in 1995.

I started my research career as a student at Southern Methodist University. My first exposure to FDA-oriented trials was as a medical student. Through my fellowship and my residency, we continued many of these trials, as well as their data collection and clinical monitoring.

The number of FDA trials that I participated in as a primary investigator, associate investigator or peripheral data collector is many. These trials have included pharmaceuticals, techniques, technology and at present laser vision correction. Today at my center we are actively involved in seven different FDA trials. It is with this background that I come to you today to try to present one person's opinion with regard to this data collection set.

I have submitted data, both for the Summit and VISX laser arms in this trial. I have participated in this trial since its inception when roughly 20 surgeons came together and decided that we needed to validate laser assisted in situ keratomileusis. We felt that our techniques and technologies were evolving toward LASIK and the laser manufacturers had no incentive to go and try to get approval for these techniques and technologies. With the brainstorming of several individuals these trials were put together. I applaud their efforts because they have not been easy.

With our support, both physically and financially the data is now being reviewed after 3 years. Some have chosen to criticize the feasibility of a surgeon-funded study. As a participant in many FDA trials, I can assure you that the rigors that I went through with this trial were equal to that of any other FDA trial. These included site visits as well as clinical monitoring and clinical monitoring of the data collection sets.

Although we did not have the economics to promote the fanfare of meetings and publications of our early work, the participants paid to hold regular meetings to present the clinical data in controlled forums. This allowed us to monitor the data and monitor our progress as a group and as individuals.

An FDA approval of LASIK will improve my delivery of medical care. At present I cannot discuss LASIK with the laser manufacturers. That creates a problem with application of the technology and techniques using the laser that has been approved for photorefractive keratectomy but is used by the majority of the ophthalmic community for laser-assisted in situ keratomileusis. The development of LASIK nomograms are definitely surgeon dependent; however, as with PRK we see that those laser nomograms can be improved when the laser companies and the surgeon are in direct communication. The inability to freely exchange ideas did not originate with the surgeons and the manufacturers. It extends from the restraints imposed by limited approval. Today we have manufacturers making lasers for photorefractive keratectomy that are in fact used for laser-assisted in situ keratomileusis. They should be able to make lasers that are specific for laser-assisted in situ keratomileusis. The difference may not be major but there will be some differences in the computer software programs for the use of these lasers with regard to specific patients and patient treatments.

Although clinical trials have never been a problem to me, they are foreign to many individuals in the general ophthalmic community. I think using a device as an off label is the choice of the surgeon, but it would be better if we had the process approved so that discussions among the laser manufacturers and surgeons could take place.

At present my patient population is confused as to what we are really doing. Why are we performing LASIK when the FDA has labeled the lasers for PRK? I do not think that sends a good message to the general population. The informed patient is a better candidate. At present when I advertise laser-assisted in situ keratomileusis I do it as a clinical treatment trial. There is always an asterisk that labels the FDA protocols we are going through. I know it is a better procedure. I have done both PRK and LASIK, but PRK has the official standing of FDA labeling. It would be much better to send a consistent message to the patient population as a whole.
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