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Patient Advocacy Treatments

Avastin is Safe | Study Shows No Link to Infection

Avastin is SafeAs reported this week in Jama Ophthalmology , the chance of contracting endophthalmitis from Avastin is no different than with the case of Lucentis.

Both are equally safe.

Several outbreaks of endophthalmitis (infection inside the eye) have occurred over the past few years questioning the safety of Avastin vs. the practices of compounding pharmacies.

What are Compounding Pharmacies?

A compounding pharmacy is NOT Walgreen’s, CVS or Rite Aid.

Compounding pharmacies can make, or “compound.” individualized specialty medications.  In the case of Avastin,  a compounding pharmacy will purchase large amounts of Avastin and divide them into smaller doses for use by retina specialists.

Both a compounding pharmacy and a pharmaceutical company are responsible for packaging and distributing drugs using approved sterile techniques.

Avastin is Repackaged

Avastin is only supplied in massive doses from the manufacturer.  As Avastin is an FDA approved anti-VEGF treatment for certain types of cancer, it is distributed only for chemotherapy treatments.  Genentech, the manufacturer, does not sell the smaller doses used for intravitreal injections (IVT).

Compounding pharmacies purchase the Avastin and re-package the drug in smaller doses for sale to the ophthalmologists.

Lucentis is Directly Shipped

In contrast, Lucentis is sold directly from Genentech to the practicing retina specialist.  As Lucentis is FDA approved for eye treatments, the Lucentis is manufactured, packaged and shipped directly to the ophthalmologist.

In 2011, an outbreak of endophthalmitis caused concern over the practices of compounding pharmacies.  Similar suspicions developed in 2012 over an outbreak of fungal meningitis – caused by contaminated steroid injections, but processed at a compounding pharmacy.

In 2013, the FDA released the Compounding Quality Act offering guidelines to reduce the chance of endophthalmitis.

Study Shows Avastin is Safe

The retrospective study just published in Jama Ophthalmology compared the rates of endophthalmitis between Avastin and Lucentis from 2005 to 2012, in essence, studying the two drugs BEFORE the Compounding Quality Act was created.

The authors found that there was no statistical differences in the rates of infection!  In other words, Avastin itself, does not cause infection.

What Does this Mean?

Historically, the threat of blinding infection (endophthalmitis) is the biggest concern with administering intravitreal injections (IVT).  It doesn’t matter if we are injecting Avastin, Lucentis, Ozurdex, etc.

In 2011, 12 cases of endophthalmitis were reported to have occurred in Florida.  Though all the injections emanated from the same compounding pharmacy, it questioned whether it was the Avastin versus the pharmacy itself.

Similar concerns were noted in cases of endophthalmitis from a compounding pharmacy in Tennessee.  Finally, an outbreak of meningitis, causing many fatalities, was linked to contamination from a single compounding pharmacy.

This study should alleviate concerns over use of Avastin causing blindness from endophthalmitis.  Concerns over the cause of endophthalmitis are limited to the  practices of the compounding pharmacies and not to the actual drugs.

Patients should find relief as Avastin continues to provide excellent treatment results from diseases such as macular degeneration and diabetic retinopathy.

 

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How I Practice My Opinion Surgery

When to Call After Your Retinal Surgery

When to call your doctor after retinal surgery.  Randall Wong, MD.  I want my patients to call me after retinal eye surgery if they develop pain and/or  loss of vision.  These two symptoms can be signs of either infection or retinal detachment, the two most dreaded complications of retinal surgery .

Eye Infection Can Blind

The most concerning post-operative complication of retinal eye surgery would be infection inside the eye.  Infection inside the eye, called endophthalmitis, often leads to blindness.

The most frequent symptoms of endophthalmitis are pain and loss of vision.  (Unfortunately, these symptoms are not 100% so please call your own doctor if you are concerned.)

I tell my patients to call if they develop pain that is not relieved by Tylenol, Advil or whatever usually works for headache.  Incidentally, I rarely need to give an prescription pain relief for any of my surgeries.  An advantage of this is the ability to monitor pain.

Pain can develop for other reasons other than infection, say increased eye pressure, but potentially blinding eye infection is obviously the most concerning.

Fortunately, endophthalmitis is very, very uncommon in retinal surgery.

Signs of Retinal Detachment

Signs of retinal detachment following retinal surgery are not as obvious as compared to naturally occurring retinal detachments (I couldn’t think of a better term.)  The usual signs of retinal detachment are flashes, floaters and loss of peripheral vision.

After retinal surgery, vision is usually poor so that the normal signs may be missed.

My advice for may patients is that they call if the vision gets worse, in any way, compared to the first day when the patch comes off.

Compared to cataract surgery, retinal surgery usually does not restore the vision quickly, if at all.  I ask my patients to distinguish between actual worsening vision versus vision which fails to improve as quickly as hoped.

In general, if the vision improves or stays the same after the patch is removed…things are fine.

What Does This Mean?

These are my own recommendations for my patients.  While I feel these are very good guidelines and have worked well for my patients over the past 20+ years, please follow the directions and recommendations of your personal doctor.

I try to practice medicine as practically as possible.  My biggest fears following retinal surgery are infection and retinal detachment.  Your doctor may have other concerns or you may have a specific condition or situation where these recommendations don’t apply.

Randy

Randall V. Wong, M.D.
Retina Specialist
Fairfax, Virginia
www.RetinaEyeDoctor.com

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How I Practice My Opinion Surgery

Emergency, Elective and Cosmetic Surgery

Elective Eye Surgery.  Randall Wong, M.D., Retina Specialist, Fairfax, VirginiaThere are different types of surgery; emergency, semi-elective, elective and cosmetic.  The differences lie between the timing (immediate), loss of life or function…or cost.  Emergency surgery must be completed immediately to avoid death, loss of a limb or organ providing a specific function.

Emergency Eye Surgery

There are two situations where retina surgery is an emergency; intraocular infection (endophthalmitis) and a retinal detachment where the macula is attached, but the retina immediately above the macula is detached.

Intraocular infection can permanently blind within hours.  A retinal detachment above the macula may spread below and detach the macula, potentially causing permanent loss of (some) vision.  If the macula is re-attached successfully, there is no guarantee full vision will return.  Thus, we try to operate before the macula detaches.

Semi-Elective Retina Surgery

Repair of an old retinal detachment, removal of ERM, closure of a macular hole are examples of semi-elective surgery.  In my opinion, the visual prognosis worsens the longer you wait.  In other words, the longer you wait to have surgery, even if performed successfully, the worse your resultant vision may be.

Cataract Surgery is Elective Eye Surgery

Cataract surgery and removal of floaters are great examples of “elective” surgery.  Elective means the timing of the surgery is up to the patient and is optional.  The timing has no effect on the outcome or results.  In both situations, there is loss of function, that is, patients can not see.

Elective procedures, however, can be covered by insurance.  Elective simply means the timing of the surgery doesn’t matter.  Insurance usually provides coverage for health problems which can be corrected.  In this example, vision is restored.

Elective Surgery is Covered

Cosmetic surgery and elective surgery are both time independent, both are optional, but cosmetic does not involve loss of function.

There is no retinal cosmetic surgery example, but other examples of purely cosmetic surgery include facelifts, breast augmentation, liposuction, etc.

Cosmetic surgery, or aesthetic surgery, does not deal with conditions related to loss of function.  It is elective and in most cases, not covered by insurance.

What Does This Mean?

I wrote this due to the many questions I receive about insurance coverage.  Emergency and Semi-Elective surgery seem pretty intuitive, but I found the differences between elective and cosmetic surgery were less clear.

If you classify surgery by the function intended to cure, you’ll have a much easier time understanding the utility, purpose and insurance ramifications.

Categories
Diabetic retinopathy Macular Degeneration Retina Treatments

The Risks of Eye Injections

The risks and complications of  injections into the eye are low.  The most dreaded complication of intravitreal injections is infection inside the eye (aka endophthalmitis).  The risk of endophthalmitis is reported to be about 0.09%.  Endophthalmitis can cause blindness.

As more and more intravitreal injections are delivered for the treatment of diabetic retinopathy and wet macular degeneration, the concern for causing blinding infection becomes greater.  The rates of infection have always been low, in fact, so low, it is difficult to estimate and study.

Intraocular Injection, Randall V. Wong, M.D., Retina Specialist, Fairfax, Virginia
Intraocular Injection

Complications of intraocular injections include;

  • Subconjunctival hemorrhage – bleeding outside the eye (scary looking), but benign
  • Pain/Discomfort
  • Cataract
  • Vitreous Hemorrhage – bleeding inside the eye
  • Retinal Detachment
  • Endophthalmitis – infection inside the eye

Retinal Detachment and Infection are the biggest concern.  The other “complications” are rather soft and either don’t cause damage or are reversible (cataract and vitreous hemorrhage).

Retinal detachment can occur if the needle enters the eye in the wrong spot and causes a hole/tear in the retina.  Additional surgery may be needed depending upon when this complication is diagnosed.  Retinal detachments can potentially cause permanent loss of vision depending upon timing.

Endophthalmitis is a nightmare.  It may occur in any intraocular procedure where the eye is penetrated by a surgical instrument.  It happens so infrequently, that it is difficult to really measure the rate at which it occurs and to study just how it occurs.  In theory, bacteria on the outside of the eye gets inside.  Does this happen during surgery, or, after?  We don’t really know.

You Have a Dirty Mouth – The eye, nose and mouth are all connected.  This is why you blow your nose after crying.   Your eye is as dirty as your mouth and nose.  There is a lot of bacteria that can cause an infection.

Pre-Operative Antibiotics are controversial.  In theory, it makes sense to treat the eye with antibiotics prior to anticipated surgery or injection.  Many cataract surgeons prescribe antibiotic drops prior to surgery, but many don’t.  The rate of infection is so low, it is hard to measure.  Many retina specialists prescribe antibiotic drops prior to intraocular injection, but many don’t (I do).

A study was just published that found no difference in the rate of infection between using antibiotics before (and after) injection compared to no antibiotics.  Over 3800 injections were studied.  What is crucial; however, is the use of a lid speculum (small wire device that keeps the eyelids spread apart) and the application of a topical iodine/povidone antiseptic.

What Does This Mean? My point is to highlight that the risk of blindness due to infection is low in intraocular injections.  As injections become more widely used for diabetic retinopathy and macular degeneration, we’ll be able to better define the rate and causes of this potentially blinding complication.  Incidentally, as the use of sustained release technology is emerging, infection will become less of a concern as fewer ‘injections” will be necessary.

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax, Virginia

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