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)!

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.

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??

Back to School: Vision Exams Recommended for Children

It's back to school time. Did you know, vision problems affect one in 20 preschoolers and one in four school-age children? Untreated eye problems can worsen and lead to other serious problems as well as affect learning ability, personality and adjustment at school.

 

The American Academy of Ophthalmology recommends timely vision and eye health screening for the detection and early treatment of eye problems in America's children. This includes institution of vision screening during the preschool years. Screening by lay people mainly detects reduced vision in one or both eyes from errors of refraction, amblyopia, and strabismus. Other eye health screening is carried out during infancy, and depends in large part on parental awareness as well as on detection of eye disease by primary care physicians. Very early detection of treatable eyes disease in infancy and childhood can have far reaching implications for vision and, in some cases, for general health.

The American Academy of Ophthalmology recommends that infants and children be screened as follows:

1. A pediatrician or family physician should examine a newborn's eyes for general eye health in the nursery. An ophthalmologist should be asked to examine all high risk infants, i.e., those at risk to develop retinopathy of prematurity (ROP), those with a family history of retinoblastoma, congenital glaucoma, cataracts, or diseases associated with eye problems, or when any opacity of the ocular media or nystagmus (purposeless rhythmic movement of the eyes) is seen. Examination of those infants should be repeated at appropriate intervals. No infant is too young for an eye examination by an ophthalmologist. An ophthalmological examination should be performed whenever questions arise about the eye health of a child at any age.
2. All infants by six months of age should be screened for ocular health by a pediatrician, family physician or an ophthalmologist.
3. Each child at age approximately 3 ½ should be screened for eye health by a pediatrician, family physician, or an ophthalmologist. Emphasis should be placed on testing of visual acuity.
4. Children at age 5 years should have vision evaluated and alignment assessed by a pediatrician, family physician, or an ophthalmologist. Those children who fail either test should be examined by an ophthalmologist.
5. Further screening examinations should be done at routine school checks or after the appearance of symptoms. Routine professional eye examination of the normal child has no medical benefit.

Most serious ocular conditions, which can be found at screening and are treatable, are identified in the preschool years. Many of these conditions are associated with a positive family history. Screening emphasis should, therefore, be directed to at risk infants and to those children in the early preschool years.

The A- B- C's of Good Vision

September is quickly approaching and it is soon time to send our children back to school.  Without good vision, a child's ability to learn about the world becomes increasingly more difficult. According to a recent study, vision problems affect one in 20 preschoolers and one in four school-age children. Since many vision problems begin at an early age, it is very important that parents make sure their children receive proper eye care. Untreated eye problems can worsen and lead to other serious problems as well as affect learning ability, personality and adjustment in school.

Good vision is essential for children as they develop physically and move though the process of education. Parents should be prepared by making sure their children receive timely vision and eye health screenings for the detection and early treatment of eye problems.

 

You can’t assume your child has 20/20 vision just because he/she never complains about not being able to see; children with vision problems may not realize the world isn’t blurry to everybody else. If your child often has headaches, tearing, tilts his head to one side to read schoolwork, or holds objects unusually close or far away to view them, it could be a sign he/she has a vision problem and should be checked out immediately.

 

Among the conditions which can be detected in children by vision screenings beginning in the preschool years are: reduced vision in one or both eyes from amblyopia, misalignment of the eyes (called strabismus), and uncorrected refractive errors or other eye defects, the most common form, nearsightedness (poor distance vision), is usually seen in school-age children and is treated effectively, in most cases, with glasses.

 

Amblyopia is poor vision in an otherwise normal appearing eye. Two common causes are crossed eyes and a difference in the refractive error between the two eyes. If untreated, amblyopia can cause irreversible visual loss. The best time for treatment is in the preschool years. Effective treatment after the child is 8 or 9 years of age is rarely achieved.

Strabismus is misalignment of the eyes whether the eye turns in, out up or down. If the same eye is habitually misaligned, amblyopia may develop in that eye. Early detection of amblyopia resulting in strabismus, followed up by treatment with patching and any necessary glasses, can be effective in restoring vision. The eyes can be aligned in some cases with glasses and in others with surgery, but neither of these treatment techniques replaces the need for patching when it is indicated.

Refractive errors cause decreased vision visual discomfort ("eye strain"), and/or amblyopia. The most common form, nearsightedness (poor distance vision), is usually seen in school-age children and is treated effectively, in most cases, with glasses. Farsightedness (poor near vision) can cause problems in seeing close work and is also treated with glasses. Astigmatism (imperfect curvature of the front surfaces of the eye) also requires corrective eye glasses if it produces blurred vision or discomfort. Uncorrected refractive errors can cause amblyopia in some cases. 

In conclusion, an ophthalmologic examination should be performed whenever questions arise about the eye health of a child at any age. Early detection of defective vision provides the best opportunity for effective, inexpensive treatment and will work to cease any vision-related learning problems in school.

Free Summertime Cookbook: Feast Your Eyes On This!

Did you know eating foods rich in vitamins and antioxidants such as beta carotene, lutein and zinc may help prevent Age-Related Macular Degeneration or slow its progression in some people?

 

EyeCare America has teamed up with celebrity chefs to create a cookbook filled with eye-healthy summertime recipes. Simply click the following link to download the complete cookbook for free.

 

Established in 1985, EyeCare America, the public service program of the Foundation of the American Academy of Ophthalmology, is committed to the preservation of sight, accomplishing its mission through public service and education. EyeCare America includes programs for seniors, glaucoma, diabetes, AMD and children, and is the largest program of its kind in American medicine.

 

 

 

Taking the Sting Out of Pool Water

Are you experiencing eye irritation after swimming in a pool? Irritation is typically not caused by high levels of chlorine, as most people suggest, it is often caused by poor pH levels, or water that is not chemically balanced. The human eye carries a pH of about 7.2. Exposure to pH levels significantly lower or significantly high than 7.2 will irritate the eye. That is why citrus fruits that are acidic and soaps and shampoos that are alkaline sting our eyes as well. A pool water pH of between 7.2-7.8 is recommended for ideal eye comfort and disinfection.

By testing the swimming pool water and correcting these levels daily, the problem should disappear. To keep from experiencing eye irritation while swimming, always wear goggles or a mask.

Safely Celebrating The Total Solar Eclipse

On Wednesday, July 22, 2009 there will be a total solar eclipse of the Sun. It is the longest eclipse that any of us may ever witness in this lifetime at 6 minutes and 39 seconds and will not be exceeded again until 2132. Although no part of the eclipse will be visible from the continental United States, China will be provided with the best view. The path of the totality will begin in Eastern India and will end about 2,000 miles south of Hawaii. This is the second in a series of three eclipses in one month. There was a lunar eclipse on July 7, and now the solar eclipse on the 22nd and a lunar eclipse again on August 6.

Whenever a solar eclipse is expected, there is much concern over risk of eye damage while watching the event. Danger to the eye is from heat, UV and excessive blue light. There is no damage to the eye in looking directly at the total solar eclipse, however the risk is greatest just prior to its totality or during its partial phases when the disk is present. The 1 percent of the Sun's surface that is just visible before the eclipse is 10,000 times brighter than the full moon. Staring at the sun under these circumstances can damage the retina. According to Dick Land, of the Schepens Research Institute at Harvard, the danger comes from the fact an eclipse changes the circular, too bright disk, into something interesting. The brightness is the same and still too great, but in eclipse there is a shape, a black part, and the crescent remaining of the sun. Now the normal safety feature of eye motion is defeated by the cognitive event of having a point to fixate. The two sharp cusps are points that the eye may focus upon and now the damaging image on the retina is stopped on the most sensitive neural tissue. This short stoppage begins damage from all mechanisms, too much blue light, too much UV, and too much heat. This damage is not recoverable. To observe the bright phases of the eclipse, a projected image is the safest. There are filter options, but caution should be used advises Mr. Land.

Total solar eclipses can be frightening events for people unaware of their astronomical nature, as the Sun suddenly disappears in the middle of the day and the sky darkens in a matter of minutes. According to Yahoo News Sourced, Indian astrologers are predicting violence and turmoil across the world as a result of this week's total solar eclipse, which the superstitious and religious view as a sign of potential doom.

Whatever your views, a total solar eclipse is a once in a lifetime opportunity to enjoy the beauty and spectacle of nature's wonder.