The LASIK Blog

Gene Therapy Shows Promise in Restoring Vision

There is an interesting article in this month's Lancet:  Age-dependent effects of RPE65 gene therapy for Leber's congenital amaurosis: a phase 1 dose-escalation trial.    Results were also reported in yesterday's New York Times.

According to the Lancet article:

Gene therapy has the potential to reverse disease or prevent further deterioration of vision in patients with incurable inherited retinal degeneration. We therefore did a phase 1 trial to assess the effect of gene therapy on retinal and visual function in children and adults with Leber's congenital amaurosis.

AAV2-hRPE65v2 was well tolerated and all patients showed sustained improvement in subjective and objective measurements of vision.  The greatest improvement was noted in children, all of whom gained ambulatory vision. 

The safety, extent, and stability of improvement in vision in all patients support the use of AAV-mediated gene therapy for treatment of inherited retinal diseases, with early intervention resulting in the best potential gain.

Leber congenital amaurosis (LCA) is an inherited retinal degenerative disease characterized by severe loss of vision at birth.  Scientists have identified 14 genes with mutations that can each cause LCA.  These genes account for approximately 75 percent of all cases of LCA.  This is the basis of this clinical trial.

According to the Times article:

The researchers injected into the eyes of the patients a virus with the normal version of the gene REP65 inserted into its genome. When the virus invaded the light-sensing cells in the eye and inserted its own DNA into the cells’ DNA, the crucial human gene was included.

Starting at about two weeks, “all 12 had significant improvement,” said Stephen Rose, chief research officer at the Foundation Fighting Blindness, which helped finance the study. That meant the inserted gene was functioning. “You’re not returning 20-20 vision, let’s be real,” Dr. Rose said, “but you’re returning a tremendous amount of vision.”

Dr. Jean Bennett, an ophthalmology professor at University of Pennsylvania who was a leader of the study, said participants could “read signs or see numbers on their cellphones, stripes on their clothes, patterns on furniture, wood on a violin or marble on a table.” Some read several more lines on eye charts.

Children improved the most, perhaps because fewer photoreceptors had decayed. But even the oldest patient, Tami Morehouse, 44, who was sometimes housebound, now walks to meet her children coming from school and “saw her daughter hit a home run,” Dr. Bennett said.

The Times article is accompanied by a video of a child treated in the trial.  The video shows a marked improvement in his ability to navigate an obstacle course.  It is well worth watching.

Although this is the early results of one clinical trial, it is exciting news.  Gene therapy may hold promise for many other retinal diseases, including Retititis Pigmentosa (RP)!

Umpires Again in Rare Form in World Series: Forget Instant Replay, "It's LASIK time!!"

Check out our LASIK the Refs caps

Well, I made it to Yankee Stadium last night to watch game 2 with my daughter.  It was a great game, won by the Yankees 3-1.  Once again the umpires reconfirmed their need for LASIK!  Lucikily the 2 bad, offsetting calls by 1st base umpire, Brian Gorman, did not affect the outcome of the game.

Reported in the New York Times:

The first disputed play occurred with the Yankees batting in the seventh. Ahead, 3-1, the Yankees had Melky Cabrera at second and Jorge Posada at first with one out. Johnny Damon pulled a low line drive to first. Howard scooped the ball with his glove on the ground and Gorman ruled an out. The Yankees thought the ball hit the ground.

Howard immediately threw to second base, where shortstop Jimmy Rollins applied the tag while Posada was standing on the base, and Posada was ruled out.

When asked about the play, Howard was evasive. “Did I catch it?” he asked. “Well, they called him out.”

Yankees Manager Joe Girardi argued vehemently and told his players not to take the field while the umpires conferred between innings, but none of the umpires saw the play differently, so the ruling stood.

I must have received 10 phone calls and texts from friends at home, watching on TV fuming over this call.  Unfortunately, they must have a policy in Yankee Stadium of not showing the instant replay of close calls.  This is probably wise, as there might have been a riot.

With all the bad calls this post season there has been a renewed interest in instant replay.  According to ESPN.com:

MLB commissioner Bud Selig said he has been soliciting outside opinion from managers and general managers the past few weeks and said no one offered a good explanation why the umpiring was so bad in the first rounds of the postseason.

"The more baseball people I talk to, there is a lot of trepidation about it and I think their trepidation is fair," Selig told reporters before Game 2 of the World Series on Thursday. "I've spent a lot of time [on this] over the past month and will spend a lot of time in the ensuing months as well. I don't want to overreact. You can make light of that but when you start to think you're going to have more intrusions -- and even if their good intrusions -- it's something that you have to be very careful about. Affecting the game on the field is not something I really want to do."

Personally, I don't think instant replay is the answer, sometimes the umps still get it wrong after a review:

“We looked at the replay and it looks like a catch,” said the crew chief Gerry Davis, who was the right-field umpire for Game 2.

Obviously the entire umpire crew got it wrong, both during the game and after the game as well!  I again make my offer to MLB:  Send your umps to me at the conclusion of the season, I will be happy to provide LASIK to them, free of charge..  anything to improve the officiating.  CALL ME!

Its off to Philly tomorrow nite, I will hopefully score some tickets, watch a better officiated game, and a Yankees win!

Medicare Appears to be Reversing Avastin Ruling

In my October 12 Blog post I wrote about Medicare's foolish decision to reimburse retinal specialists less than their costs for treating macular degeneration with the much- less expensive drug, Avastin.  This decision would cost our government millions of dollars annually.  I questioned how this system could ever manage healthcare.

I received an e-mail from both Dr. Joel Eichler (EyeCare 20/20's Retinal specialist) and the AAO today:

Kohl Indicates CMS Will Reverse Avastin Reimbursement Decision

The Academy is encouraged by an announcement today from Sen. Herb Kohl, D-Wis., chairman of the Senate Special Committee on Aging, who indicated CMS intends to reverse its Oct. 1 implementation of a new reimbursement code (Q2024) created for physicians (including ophthalmologists) who use smaller doses of Avastin for patient treatments. The Academy, along with the American Society of Retina Specialists, the Macula Society and the Retina Society, had challenged the new code’s implementation because it poses significant challenges for members’ practices and our patients’ access to care.

While the Academy is pleased by Kohl’s announcement, we await official word from CMS and details of its reversal, which are expected later this week.

I am hopeful this reversal will go into effect ASAP, the cost savings are enormous.  I will keep you all posted!

Who Should Implant Your Cataract Premium IOL?

There was an interesting presentation Sunday at the Annual AAO meeting in San Francisco given by Dr. Vinjay Shah.  EyeWorld Magazine summarized his findings:

Residents lacking in premium IOL, pediatric cataract procedure experience

Third year residents are not getting enough hands-on experience leading pediatric cataracts and implanting premium intraocular lenses (IOLs) according to Vinay A. Shah, M.D., University of Missouri, Kansas City, and his colleagues. Dr. Shah sent a survey to every third year resident accredited with the Accredited Council for Graduate Medical Education (ACGME) in the United States; 154 (35.5%) of the 434 residents completed the survey. Through this self-reported survey, residents responded that they were getting ample chances at extra-capsular cataract extraction (ECCE) with 40 residents having done more than 50 surgeries. But in terms of pediatric cataract surgery and premium IOL implantation, their experiences were lacking. For example, 102 residents never implanted a premium IOL, and all but seven residents had implanted premium IOLs in 10 patients or fewer. Similarly, 118 residents never performed a pediatric cataract surgery, and only three residents had done more than 10 procedures.

This interesting study leads me to ask two important questions:

1. Should residents even implant any premium IOLs?
2. Who should one go to if they want a premium IOL at the time of their cataract surgery?

Let me answer these two questions by first defining my goals of different surgical procedures:

1. Cataract surgery is preformed on a patient when their cataracts are causing a decrease in vision that is interfering with their daily lifestyle.  The goal of cataract surgery is to improve the patient's best corrected vision.  If a patient has pre existing astigmatism, they will most likely still need distance glasses after cataract surgery.  All patients will also still need to wear reading glasses after cataract surgery, as the IOL does not focus for near objects.
2. Many patients would like to decrease their dependence on glasses.  This is the goal of premium IOLs.  A toric IOL will decrease pre existing astigmatism and improve distance vision without glasses.  A multifocal IOL will allow one to read without glasses.  Uncorrected vision after cataract surgery may be further improved with LASIK surgery.

In my opinion any surgeon who is offering premium IOLs MUST have the following attributes:

• Must be performing perfect, pristine cataract surgery, on a very consistent basis.  This only comes with experience and volume.  I would suggest going to a surgeon who does over 30 cataracts a month.
• Must fully understand refractive surgery.  One of the biggest complaints I get from patients who see me for second opinions after premium IOL implantation is that they are unhappy with some aspect of their vision.  Most of these patients have a residual refraction in their eyes.  A simple LASIK procedure will usually correct this problem.  Many times, their operating surgeon does not offer this as an option, as they do not provide LASIK services.
• Must have vast experience in premium IOL implantation.  There are many nuances that must be overcome to achieve success in the refractive cataract patient.  I would suggest going to a surgeon who does at least 20% premium IOL implantations of his cataract volume.

So, to answer the two questions I posed earlier:

1. I do not believe residents should be implanting premium IOLs.
2. If one is interested in reducing their dependence on glasses following cataract surgery, I would suggest going to a high volume surgeon with vast experience in both premium IOL implantation and refractive LASIK services.

Newest Trends in Eye Care From Annual AAO Meeting I

This week is the Annual Meeting of the American Academy of Ophthalmology (AAO).  Over the next few days I will report on a few of the latest trends being presented at the meeting in San Francisco.  Many of these short synopsises will be taken from "Academy Live" an e-mail; alert from the AAO.  Each synopsis will be followed by some of my personal commentary.

LASIK safe for Form Fruste Keratoconus?  Damien Gatinel, MD, went back and looked at outcomes after LASIK and PRK when they were performed inadvertently in patients with suspected keratoconus.  “Three years later, the results are so far satisfactory,” Dr. Gatinel said, “There was no topographical sign of ectasia in these patients.  Even if it’s not recommended, he concludes that refractive surgery seems safe in topographically diagnosed keratoconus suspect eyes with a good biomechanical profile. When the audience was polled as to whether they would perform surgery on patients with forme fruste keratoconus, 77 percent said they would not.  Even after hearing this evidence, I personally feel that it would be foolish to do LASIK on a suspected keratoconus patient, the risks are just too high!

New Phakic IOL from Alcon holds promise.  Ronald R. Krueger, MD, medical director of Refractive Surgery at Cole Eye Institute, evaluated safety outcomes from clinical trials of the AcrySof Phakic Angle-Supported IOL.  Vision increased by two or more lines for 20 percent of subjects, one line for 44.6 percent and unchanged for 33.8 percent.  Phakic IOLs are an excellent method of providing superb vision in high myopes.  I currently use the Visian IOL, a posterior chamber IOL manufactured by Starr.  The Alcon lens will allow more ophthalmologists to provide this technology to their patients once it is approved, as it will be a much simpler IOL to implant.

Avastin vs Lucentis Trials underway:  Avastin and Lucentis are competing in a hefty schedule of six head-to-head randomized clinical trials directly comparing their use in AMD patients, said Daniel F. Martin, MD.   Initial study results are expected to be available in early 2011.

Here’s the status of each of the studies:

• The NEI-sponsored CATT (Comparison of AMD Treatments Trial) study began enrolling an estimated 1,200 wet AMD patients at 44 sites in the United States in February 2008. The four-arm study comparing bevacizumab and ranibizumab on fixed and variable schedules is proceeding well, according to Dr. Martin, with one-year results targeted for 2011.

• In April 2008, researchers in the United Kingdom began enrolling an anticipated 600 patients at 17 sites in the IVAN (Inhibit VEGF in Age-related choroidal Neovascularization) study. This four-armed study compares monthly bevacizumab 1.25 mg and ranibizumab 0.5 mg injections given over two years with three monthly injections followed by PRN dosing.
• The four-site German VIBERA study started enrolling 360 AMD patients in 2008 to receive three monthly bevacizumab 2.0 mg or ranibizumab 0.5 mg injections and additional injections as needed.
• The Austrian MANTA study began assigning an anticipated 320 AMD patients in June 2008 to three monthly bevacizumab or ranibizumab injections, with additional treatment as needed.
• Researchers in Norway began enrolling an anticipated 450 patients in the 12-site LUCAS study in March. Subjects receive bevacizumab 1.25 mg or ranibizumab 0.5 mg monthly as needed until dry, with intervals between doses decreasing over time.
• French investigators opened enrollment this fall in the 600-patient, 20-site GEFAL study. Subjects are randomized to receive three initial monthly injections of one of the two drugs.

I am anxiously awaiting the results of these studies, as I am a strong advocate for the use of Avastin as a primary therapy in the treatment of SMD.

Free LASIK Again Offered to Major League Umpires

Three bad calls in Game 3 and several in Game 4 of the ALCS between the Yankees and Angels have again brought attention to the inconsistent officiating in baseball.  Hats off to third base umpire, Tim McClelland, who admitted to his bad calls  in a post game interview.  "After looking at replays..  obviously there were two missed calls, not obviously, there were two missed calls...  I'm out there trying to do my job the best that I can.."  Once again EyeCare 20/20 is offering to aid the umpires in doing their job better.  Forget instant replay.  Tim McClelland, or any major league umpire, give us a call.  We would be happy to improve your vision free of charge with LASIK! 

This is what our LASIK the Refs program is all about.  Here is a copy of a recent press release:

LASIK THE REFS!

EAST HANOVER, NJ - Due to the spate of recent blown calls in professional sporting events, including last night’s American League Championship Series, local ophthalmologist Dr. Cary Silverman is offering free LASIK surgery to any major league umpire or referee.  As Medical Director of EyeCare 20/20, Cary M. Silverman, M.D., oversees one of the premier vision care facilities in the tri-state area, and the first practice in New Jersey to offer treatment using custom wavefront LASIK with the ALLEGRETTO WAVE® laser.

 “This is maddening,” Silverman said, “These are the greatest athletes on the biggest stage in the world and they deserve to have the games officiated correctly.  Frankly, so many of the errors from this baseball post-season and the NFL regular season could have been avoided if the officials had better eyesight.  LASIK is the best way to achieve that and I make an open offer to any official from the major league sports to utilize our service, for the good of the game.”

There have been several calls in the Twins/Yankees and Angels/Yankees playoff series that officials admitted were incorrect after viewing replays post-game.

LASIK uses a computer-controlled laser to reshape the cornea and correct refractive errors such as nearsightedness, farsightedness, and astigmatism. Dr. Silverman employs the latest advances in LASIK surgery to provide patients with the highest level of vision correction possible. With the ALLEGRETTO WAVE® laser technology, he is able to customize the LASIK procedure to the vision needs of each individual patient.

Silverman was recently in the news for providing free LASIK to eight current members of several United States Olympic teams, including medal contending speedskaters Chad Hedrick and Katherine Reutter.  For more information on Dr. Silverman’s Olympic initiative, go to: www.lasikforthegold.com.  For more about EyeCare 20/20, go to: www.eyecare2020.com. For more information on recent blown calls and the LASIK THE REFS program, go to: http://facebook.com/lasiktherefs.

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VISION HARVEST 2009: Free Cataract Surgery Offered For Those Patients Who Are Uninsured And In Need Of Treatment

Here is a copy of a press release that went out today announcing Vision Harvest 2009.  Several of the surgeons at my surgical center and I have decided to provide free cataract surgery to patients without insurance and unable to pay for the procedure.  The date of this event will be the day before Thanksgiving, November 25, 2009.  All patients interested in this program may contact the Vision Harvest 2009 hotline at 973-200-8250 or my ofice at 973-560-1500.

So far the release has been picked up by NJNewsRoom.com.  I will keep you all up to date with regards to the program.

I would like to take this opportunity to thank Nancy Lord, Administrator at River Drive Laser & Surgery Center; Jay Tendler, MD, our anesthesiologist who will be providing free anesthesia services; Gene Maresca of Alcon Labs, who will providing the surgical supplies; Steve Kramaritsch of Alcom Pharamceuticals, who will be supplying eye drops for post op care; Kerri Muli, administrator of EyeCare 20/20, for organizing the program; and Alana Tendler, who will be assisting us in scheduling patients for the event.

FOR IMMEDIATE RELEASE

 

Contact: Keri Muli @ 20/20 Communications, Inc.

P: 973-560-1500

F: 973-560-0419

info@eyecare2020.com

 

VISION HARVEST 2009

Local Area Eye Surgeons Will Be Giving Back This Thanksgiving Season

    Free Cataract Surgery Offered For Those Patients Who Are Uninsured And In Need Of Treatment

 

Elmwood Park, NJ, October 20, 2009- On November 25, 2009, doctors at the River Drive Surgery and Laser Center of Elmwood Park, New Jersey, will perform FREE cataract surgery during Vision Harvest 2009, for those that are uninsured and can’t afford to pay for the procedure.  In 2008, the United Status Census Bureau reported, that there is an estimated 46.3 million Americans without health insurance. “With so much emphasis in the news discussing the current recession and those Americans who have been affected by unemployment and loss of health insurance, my colleagues and I believe it is the perfect time to give back to our community. We all agree no one should go without needed cataract surgery due to finances,” said East Hanover ophthalmologist, Cary M. Silverman, M.D. who organized the event. “We want to make sure that any vision impaired person in New Jersey without insurance or financial resources learns about this remarkable program.”

 

Over the next few weeks, participating eye physicians will be evaluating prospective cataract patients and scheduling them for their free procedure.  Eligible patients will have all eye examinations, testing, medications, and surgery provided to them free of charge.

 

Participating ophthalmologists in this year’s Vision Harvest program include:

 

·       Anthony D’Amato, M.D.- Advanced Eye Surgeons of North Jersey, Bloomfield, NJ/ Dover, NJ

·       Phillip Eichler, M.D.- Eye Institute of Essex, Belleville, NJ

·       Michael Farbowitz, M.D.- Short Hills Ophthalmology, Short Hills, NJ

·       Orazio Giliberti, M.D.- Giliberti Eye and Laser Center, Totowa, NJ

·       Scott Pomerantz, M.D.- Metropolitan Eye Care, Paramus, NJ

·       Cary M Silverman, M.D.- EyeCare 20/20, East Hanover, NJ

For more information, interested patients should call 973-200-8250 to set up a free evaluation to determine their candidacy.

 

Cataracts are a progressive condition that cause the eye's lens to become cloudy, and eventually opaque leading to a progressive dimming of your vision. The exact cause of cataracts is unclear, but they occur in everyone as they age. Cataracts may be the result of a lifetime of exposure to ultraviolet rays, and other factors such as cigarette smoking, diet, and alcohol consumption. Cataracts can also occur at any age as a result of other causes such as eye injury, exposure to toxic substances or radiation, certain medications or as a result of other diseases such as diabetes.

 

About River Drive: Located in Elmwood Park, New Jersey, River Drive Surgery and Laser Center was created as an ophthalmic ambulatory surgery facility dedicated to providing patients with excellence in eye care in a warm and caring environment. The center is designed as a facility which is planned and administered to render a safe, comfortable, effective environment for patients and personnel, and to give assistance to the medical staff in meeting certain restorative health needs of patients without regard to race, color, religion, sex, age, or national origin.

 

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FDA Announces Plans for LASIK Quality of Life Project

In an October 15 press release, The FDA announced its plans to implement a 3 pronged initiative to evaluate "quality of life" issues associated with LASIK.  This study will be implemented in collaboration with the National Institute of Health and the US Department of Defense.  The goal of this initiative is to "determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems."

The 3 phases of the initiative will be:

1. Design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.
2. Evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.
3. A national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are under.

According to the release: "The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery."

I think that this FDA initiative is a wonderful idea.  An organized study such as this can only improve our understanding and outcomes for this incredible procedure.  Once the online survey is made available, EyeCare 20/20 intends to forward the link to all our past LASIK patients so that they may participate in it.  We will also implement a "modified" online survey of our own to compare national results with those of EyeCare 20/20.

Avastin vs Lucentis: Why our Gov't Will Never Manage Healthcare Efficiently!

There have been several articles in the New York Times discussing how the current health care proposals currently being debated will do little to control health care costs.  In my opinion government control of health care and health care cost control are mutually exclusive!  A case in point:  the Avastin vs Lucentis controversy.

I have previously discussed the Avastin vs Lucentis controversy in this blog.  Basically, there are 2 medications used to treat certain types of macular degeneration: 

• Avastin, a cancer medication, is used as an of label use to treat macular degeneration at a cost of about $50 per injection

• Lucentis, approved for the treatment of macular degeneration at a cost of about $2000 per injection

These drugs need to be used every 2 to 3 months to control macular degeneration.  Both drugs are made by a Roche subsidiary, Genentech.  In my opinion, both drugs are equally efficacious in the treatment.  In the past a doctor could make more money by using the more expensive Lucentis, as the law allows a percentage mark up on injectables.

The New York Times reported on October 1 a change in the Medicare rule concerning these medications.  Medicare will continue to fully reimburse the doctor who uses the $2000 Lucentis , but will only reimburse the doctor $7.20 for using Avastin, which costs the doctor $50!  So now there is a double incentive for using the $2000 treatment every few months:

1. Ability to make more money ( a percentage of the more expensive medication)
2. Using the less expensive medication will cost the treating doc $42.80 out of his own pocket.

Do the math, with over 1.7 million people suffering from macular degeneration, this myopic policy will cost the tax payer hundreds of millions of dollars annually.  It will also cost the patients an additional $400 per treatment, the 20% that Medicare does not cover.

In the past I have stopped referring my patients to retinal surgeons who use Lucentis before Avastin.  Now, with this change in policy, I can't blame them for not wanting to "pay" to treat these patients!

What I do know is that our health care system is a mess.  I don't trust the Democrats, I don't trust the Republicans, I don't trust Obama, and I don't trust the insurance industry!  Who do you trust??

LASIK the Refs: Thank-you Phil Cuzzi!

Mark Teixeira's walk off home run in the 11th inning ended one of the most exciting baseball games this long time Yankees fan has seen in a while.  This game will more likely remembered for another blown call.  In the top of the 11th, Umpire Phil Cuzzi called a ball hit by the Twins' Joe Mauer foul.  Replays show that the ball landed in fair territory, costing Mauer a double.  He ended up with a single instead.  The Twins did end up loading the bases with no outs and still failed to score a run, so who knows if this bad call really made any difference in the game's outcome.

There is an excellent article in today's Star Ledger, "An ump's life means living on a fine line".  This article discusses Cuzzi's journey to become a MLB ump.  What I like about Cuzzi is that he is a stand up guy who admitted his mistake Friday night. 

"There is no excuse.  I missed the play.  It's a terrible feeling.  As badly as everyone on that field may have felt, I don't think any of them had a worse night's sleep than me."

It turns out that Cuzzi is a Jersey guy.  He lives in Nutley, no more that 20 minutes from EyeCare 20/20!  Once more extend my offer to a ref in need.  If Phil Cuzzi wears glasses or contact lenses, and if LASIK could improve his performance on the field, I would be more than happy to provide the LASIK free of charge.  Even if that call did benefit my Yankees!