1 REFRACTIVE SURGERY REVISITED Sightline Ophthalmic Associates February 22, 2015 Louis J. Phillips, OD, FAAO
2 INTRODUCTION History Of Laser Vision Correction And Optometry s Involvement. The Western Pennsylvania Experience The Vision for Optometry. The Evolution of Sightline Ophthalmic Associates. Refractive Surgery Today, Nationally and Locally. The Antagonists and Morris Waxler. The FDA Lasik Quality of Life Collaboration Project. What Are Your Colleagues Doing In Their Practices? What Should You Do?
3 THE TAKE AWAY Refractive surgery has only gotten better. Volume is drastically down for the last 6 years but could be climbing. valid. The early motivation to be involved in refractive surgery is We think you should be involved and we will help. still
4 HISTORY OF LASER VISION CORRECTION AND OPTOMETRY S INVOLVEMENT. First Laser Approved For PRK October 1995 Summit Limited Range myopia To And No Astigmatism Opening Aperture Eximer Laser Second Laser Approved March 1996 Visx First Parameter Expansion ( up to 4D of astigmatism) April 1997 Visx Expanded myopia to January Visx Lasik Approved 1999 Many More Approvals For Flying Spot, Expanded Parameters And Many Additional Lasers Since.
5 SUMMIT LASER
6 HISTORY OF LASER VISION CORRECTION AND OPTOMETRY S INVOLVEMENT. First Laser Approved For PRK October 1995 Summit Limited Range myopia To And No Astigmatism Opening Aperture Eximer Laser Second Laser Approved March 1996 Visx First Parameter Expansion ( up to 4D of astigmatism) April 1997 Visx Expanded myopia to January Visx Lasik Approved 1999 Many More Approvals For Flying Spot, Expanded Parameters And Many Additional Lasers Since.
7 VISX LASER
8 HISTORY OF LASER VISION CORRECTION AND OPTOMETRY S INVOLVEMENT. First Laser Approved For PRK October 1995 Summit Limited Range myopia To And No Astigmatism Opening Aperture Eximer Laser Second Laser Approved March 1996 Visx First Parameter Expansion ( up to 4D of astigmatism) April 1997 Visx Expanded myopia to January Visx Lasik Approved 1999 Many More Approvals For Flying Spot, Expanded Parameters And Many Additional Lasers Since.
9 HISTORY OF LASER VISION CORRECTION AND OPTOMETRY S INVOLVEMENT. Femtosecond Laser For Flap Creation Approved 2001 Intralase Wavefront Guided Ablation Approved 2002 Visx Complicated Treatment Took Prescription Decision Out of the Hands of Optometrist Became Too Confusing Changed ablation profile which was biggest improvement Aspheric Treatment Profile 2003 Allegretto
10 ALLEGRETTO LASER
11 OPTOMETRY S INVOLVEMENT Many Company s Came Forward To Start Laser Centers Most Involved Optometry In Some Way We Had The Young Myopes Some Optometrists Got Involved Starting Centers Was Threatening To Optometrists No One Knew How Big This Would Be Ophthalmology Would Be Coming For Our Refractive Patients
12 THE WESTERN PENNSYLVANIA EXPERIENCE THE VISION FOR OPTOMETRY. Ealy 1995 it became obvious LVC was going to work Four optometrists met to decide what should be done to shape LVC in Western PA. Decided to bring all the optometrists and ophthalmologists together to present a plan to start a center that would: deliver quality care share the care of the patient with the referring doctors (co-manage) not market against the referring doctors make the optometric office the entry point for LVC Asked for $50 from every doctor to do a search for a corporate partner to invite into Western PA (150 docs)
13 THE WESTERN PENNSYLVANIA EXPERIENCE THE VISION FOR OPTOMETRY. Invited corporations to town to be interviewed Found no one that had our model Went back to the doctors proposing to establish our own center Wanted no individual to control large shares of the corporation Proposed maximum investment be $11,000 Asked for $1,000 for first share and pledge for additional shares After establishing a business plan asked for remaining money 90 investors jointly owned the center AllSight Laser Center
14 THE WESTERN PENNSYLVANIA EXPERIENCE THE VISION FOR OPTOMETRY. Purchased a Summit laser and opened the center in 1996 Trained the referring doctors in how to co-manage PRK Over first two years continued to look for a corporate partner Partnered with TLC in 1998 Turned management over to TLC and retained 49% ownership (ultimately 30%) Retained a number of super majority rights TLC treated Tiger Woods Began to market to the public Board opposed but was rebuffed by corporate
15 THE EVOLUTION OF SIGHTLINE OPHTHALMIC ASSOCIATES. Left TLC in December 2000 Opened Sightline Laser Center in Early 2001 as a refractive referral center In 2004 began doing medical eye care on a referral basis only as SLOA In 2005 opened second location in Chippewa Beaver Falls Area and OD joined the practice Charlene Maloney,
16 THE EVOLUTION OF SIGHTLINE OPHTHALMIC ASSOCIATES. In 2006 opened third location in Pleasant Hills In 2008 Dr. Paul Phillips, MD joined the practice and added corneal surgery In 2011 opened New Castle office In 2013 Chris Carver, OD joined the practice In 2014 Dr. Valliammi Muthappan, MD (Dr. Valli) joined the practice
17 THE EVOLUTION OF SIGHTLINE OPHTHALMIC ASSOCIATES. With the addition of Dr. Valli we are committed to being the and anterior segment practice in Western Pennsylvania. Refractive surgery is an integral part of an anterior seg. Practice. premier cornea We are committed to continuing and building our refractive surgery in support of the optometric community. We believe that optometry should be involved in refractive surgery will help in that regard. practice and we
18 QUARTERLY US LASIK/PRK PROCEDURES Q1 01 THROUGH Q1 14 Over 1,200,000 procedures Sx/qt 600,000 since 2008 Source: Market Scope May 2014
19 REFRACTIVE SURGERY TODAY--LOCALLY. Same trend locally Even with the reduction in volume approximately 6,000 procedures done per year in Western Pennsylvania. Some of these patients are yours whether you refer them or not. If the upward trend continues, then you could be loosing more patients
20 REFRACTIVE SURGERY TODAY WHAT ARE YOUR COLLEAGUES DOING? Interviewed 10 offices, all of which were in practice in 1996 The doctors Not marketing as much Not mentioning it to patients Too busy EHR, PQRS Better contact lenses Surprisingly, only one doctor had concerns about the risks other one or no patients with only minor problems Target has narrowed Patients are not interested doctors had
21 REFRACTIVE SURGERY TODAY WHAT ARE YOUR COLLEAGUES DOING? Patients They don t ask anymore Cost Fear maybe Shopping for care elsewhere didn t think so Doing well with current refractive correction Not the in thing to do External forces Economy does upturn reflect that? The market place/internet negative stories
22 WHO IS MORRIS WAXLER?
23 THE NEGATIVE INFORMATION Morris Waxler Constant critic of LVC and the FDA Former official at the FDA when the first lasers were approved There was a great deal of turmoil with first approvals Uses his past employment at the FDA as credibility or is it a conflict Has filed suit and requested the withdrawal of all laser device approvals He is the poster child for the active patient groups against LVC His activity has caused the FDA to conduct a review of LVC (LQOLCP)
24 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT Began in 2009 Important accomplishment was developing and validating a questionnaire Then did a preliminary study on 534 patients two prongs Naval air station group, PROWL patients 482 eyes -7.8 to +4.0 Myopia mean to 51 yoa (mean 29.1) Five private practices PROWL patients 584 eyes to +4.1 Myopia mean -4.0 Ages not reported Results reported at AAO meeting in October 2014
25 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 NAVY RESULTS AT 6 MOS POST OP VISUAL SYMPTOMS 32% gained 1 or more lines of BCVA 2% lost 1 line 1 patient 20/16 to 20/25 98% 20/16, 99.5% 20/20, 100% 20/25 Patients with Pre-op BCVA visual symptoms achieved a 70% reduction post-op Patients with no Pre-op visual symptoms had 20% post-op symptoms
26 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 NAVY 242 PATIENTS, -7.8 TO +4.0 (MEAN 4.0), 21 TO 52 YOA(29.1 MEAN) RESULTS AT 6 MOS POST OP VISUAL SYMPTOMS Overall, 40% of the patients had pre-op BCVA visual symptoms compared with 20% post-op UCVA. 5% of pre-op patients with corrected vision compared with 1% of patients post- op UC had significant difficulty at least one daily activity. 97.0% of the patients were satisfied with their UC vision post-op.
27 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 NAVY RESULTS AT 6 MOS POST OP DRY EYE 90% had no post-op dry eye symptoms and 100% had minimal or less 19% of patients had dry eye symptoms pre-op and 10% post-op 21% of patients who had no pre-op symptoms had symptoms post-op 65% of patients who had symptoms pre-op had no symptoms post-op Oxford objective scale of dry eye stain showed similar results
28 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 2 FIVE PRACTICES RESULTS AT 3 MOS POST-OP VISUAL Pre-op 45% satisfied with corrected vision though only 20% were VERY satisfied. At 3 mos 96% satisfied with vision uncorrected and 91% were VERY satisfied. Pre-op with correction 5% of patients had difficulty or were unable to do usual activities while post-op only 1% uncorrected reported the same.
29 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 2 FIVE PRACTICES 292 PATIENTS, TO +4.1 (MYOPIC MEAN 4.0), DIDN T REPORT AGE RESULTS AT 3 MOS POST-OP VISUAL symptoms. Graph shows larger corrected pre-op visual symptoms than post-op uncorrected No one lost more than one line of corrected visual acuity. 96% of the patients had 20/20 UCVA.
30 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 2 FIVE PRACTICES RESULTS AT 3 MOS POST-OP DRY EYE 14% of patients had their dry eye symptoms worsen while 45% had them improve. (41% stayed the same) 78.7% of the pre-op patients showed no staining on the Oxford Scale compared to 83.5 post-op. 30% of the patients with no dry eye symptoms had them at 3 mos 23% were listed as mild.
31 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 AND 2 CONCLUSIONS My biased summary Similar results for both arms Outcomes can only be described as positive Shows that many patients even with correction have significant pre-op problems It is likely that many of the post-op symptoms would be eliminated with enhancements Study mirrors the results of a meta analysis by Kerry Solomon in % satisfaction Both sides of this debate will use the information to their advantage The conclusions reported by the authors of these studies is proof of that difference
32 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 AND PROWL 2 CONCLUSIONS ELIZABETH M. HOFMEISTER, MD, CAPT, MC, USN PROWL 1 showed excellent objective clinical results. While some patients reported new visual symptoms, more patients reported resolution of their pre-op visual symptoms. Very few patients were dissatisfied with their Lasik surgery at 6 mos. Very few patients were dissatisfied with their Vision at 6 mos.
33 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 AND PROWL 2 CONCLUSIONS ELIZABETH M. HOFMEISTER, MD, CAPT, MC, USN Oxford score 1 mos. then improved. While some patients developed worsening dry eye symptoms, more patients dry symptoms improved. eye The prevalence of patients with normal OSDI scores increased over time for the cohort.
34 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 AND PROWL 2 CONCLUSIONS MALVIN B. EYDELMAN, MD, FDA DIRECTOR OF OPHTHALMIC DEVICES Up to 30% developed new dry eye symptoms. Up to 4% of subjects were dissatisfied with vision. Overall prevalence of visual symptoms did not increase post-operatively. 45% of subjects who were symptom-free pre-operatively developed at least one new symptom.
35 FDA LASIK QUALITY OF LIFE COLLABORATION PROJECT PROWL 1 AND PROWL 2 CONCLUSIONS MALVIN B. EYDELMAN, MD, FDA DIRECTOR OF OPHTHALMIC DEVICES Visual symptoms were very or extremely bothersome in up to 4% of subjects not wearing correction. Visual symptoms caused a lot of difficulty with or resulted in inability to do visual activities in up to 1% of subjects not wearing correction. Much larger study needed to reach statistical significance because of low complication rate.
36 THE SURVEY Mode of practice Private optometric Corporate affiliated Private optometric/ophthalmologic Other Doctors who co-manage? % LVC should: Not be done at all Reserved for a select group of patients Should or could be offered to all qualified patients
37 THE SURVEY For my patients who want LVC I: refer to a specific center give them the names of multiple centers and let them choose give patients my opinion and allow them to find a center Compared to 10 years ago there is: more less about the same amount of laser vision surgery in the practice. Been in practice less than 10 years.
38 THE SURVEY Patients in practice who have problems which negate the gains made. yes no Number The biggest barrier to laser vision correction in your practice: I do not bring it up as often opposed to LVC too busy just not thinking about LVC as much Patients are not interested Patients fear of the procedure Improvements in CL technology have resulted in fewer candidates Patient affordability of the procedure
39 THE SURVEY I have referred a patient for a refractive procedure other than LVC yes no If patients presented who were a candidates I would refer for: phakic IOLs (ICL) clear lens exchange multifocal or accommodating IOLs for cataract surgery toric IOLs for cataract surgery none of the above. number responding
40 WHAT SHOULD YOU DO ABOUT REFRACTIVE SURGERY? The decision is yours that s why people come to you Must decide for yourself and your practice But do offer an opinion Some of your patients will have refractive surgery Help them with their decision Research and refer to a center
41 WHAT SHOULD YOU DO ABOUT REFRACTIVE SURGERY? My personal bias is that refractive surgery should be in your armamentarium. Must develop a strategy to efficiently present it in your practice Don t need to market externally Patients must know you do it so they will come to you Most effective marketing is one on one with patient The intake questionnaire approach
42 WHAT SHOULD YOU DO ABOUT REFRACTIVE SURGERY? The intake questionnaire approach Know patients interest level before starting the exam Mention it to everyone also contacts We want to help revitalize your refractive surgery practice
LASIK Quality of Life Collaboration Project (LQOLCP) FDA/NIH/DOD Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices ODE/CDRH/FDA Financial Disclosures I do not have
When To Laser, When To Implant, When To Do Both Scott MacRae, MD Professor of Ophthalmology Professor of Visual Sciences StrongVision Refractive Surgery Center University of Rochester Eye Institute Refractive
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Page 1 of 5 VA high quality, complications low with phakic IOL Use in keratoconus will continue, one surgeon predicts; another ponders long-term safety Nov 1, 2007 By:Nancy Groves Ophthalmology Times Several
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