Contact lens solutions will soon be required to have two new additions to their labeling. Although most manufacturers no longer label solutions “no rub” the F.D.A. will require rubbing lenses as part of disinfecting cycle on labeling for all multipurpose contact lens solutions. The other change will be to add a discard after opening date in addition to the expiration date already required..
Two separate incidences of outbreaks of serious eye infections the last several years have prompted theses changes. While the evidence points to non compliance with manufacturer recommendations of product use, it is felt that a higher error of margin needs to be built into the solutions regimens.
Testing of solutions is not as simple as you would think at first glance. Historically, the FDA has required two different methods of testing. Simplifying the process it can be viewed as primarily two different tests. The first is adding bacteria and fungal microorganisms to samples of the solutions and after the manufacturers specified time period for disinfecting they must reduce the number of bacteria by 99.9% and the fungi by 90%. The second method of testing involves soaking the contact lenses in the microorganisms and then being disinfected as the manufacturer recommends. The lenses are then used to grow the bacteria and fungus on a special type of growth media. After a specific time period the number of live organisms are counted. These are referred to as colony forming units and less than 10 gives a passing grade. Tests must also be done to show that the solutions are not toxic or irritating to the eyes.
Bacteria chosen for testing in the past include Pseudomonas aerginosa, Serratia marcescens, and Staphylococcus aureus. The first two are in a category called gram negative bacteria and the third is gram positive. Bacteria can be classified gram negative or positive by how their cell wall retains dye, and gram negative bacteria tend to be responsible for more serious infections. While most tropical and semi tropical climates show gram negative bacteria and fungal eye infections are more prevalent, temperate northern climates tend to have more gram positive bacterial infections associated with contact lens related eye infections. Pseudomonas is present almost everywhere in humid climates. While these three bacteria do cause a high incidence of contact lens related eye infections, there are numerous other bacteria that cause infections. While fungal eye infections are rare, Candida albicans and Fusarium solani are the two tested for. One of the recent outbreaks was caused by Fusarium.
We can’t test for every possible microorganism, the time and cost would be prohibitive. This is the best mix determined in the past. With Acanthamoeba being the organism resulting in the other recent outbreak it may be added to testing procedures in the future.
Reducing microorganisms to a level that the eyes immune system can handle is one assumption for test requirements. Bacteria are present at low levels at any given time in most peoples eyes. Many variables are left out of the testing protocols. The age of a lens may effect how well bacteria adhere. The condition of the contact lenses case, the wearers personal hygiene and individual variation in immune response, all factor in bacterial growth. The therapeutic dose of a disinfecting agent shows individual variation. Some bacteria mutate and become resistant to disinfectants, and also can develop coatings on the lens to render the solutions less effective. Some microorganisms may become more common, virulent, or our daily exposure to them may increase for various reasons. For example, hot tubs have increased our exposure to acanthamoeba. The use of antimicrobial hand soaps may result in mutations to bacteria that were not a problem for the eyes in the past. Incomplete use and under dosing of antibiotic treatment may result in the same problem. The microorganisms used for testing are standardized and not necessarily representative of the current existing strain of that microorganism. Even the culture media used is standardized and different from the eye contact lens environment presented for the bacteria to develop in.
Rubbing a contact lens helps remove surface films and debris and allows the disinfecting solutions to work better. In the imperfect world of solution testing it is expected to help reduce eye infections.
The second change is more questionable. Solutions do have a lifespan when the disinfecting action drops below an effective level. They also could remain unopened until close to this date and then be used, resulting in usage past the time the solution was effective. Alternatively, once opened, the solution is subject to environmental contamination from bacteria that could exceed its capacity over time. The problem is putting two different dates on a bottle can be confusing. Proper wording can help, but one glance in any refrigerator will likely reveal we all aren’t very good at the two date dilemma. Time will tell, but short expiration dates on all solutions might be a better approach. Best of all would be a solution that changes into a horrible color after it has been open for a month. Of course with teenagers, that unfortunately might be an incentive to continue using it.
Contact lens solutions will soon be required to have two new additions to their labeling. Although most manufacturers no longer label multipurpose solutions “no rub” the F.D.A. will soon require adding a rubbing step to the care instructions. The other change will be to add a discard after opening date in addition to the expiration date for multipurpose contact lens solutions.
Two separate incidences of outbreaks of serious eye infections the last several years have prompted theses changes. While the evidence points to non compliance with manufacturer recommendations of product use as the cause, it is felt that a higher error of margin needs to be built into the solutions.
Testing of solutions is not as simple as you would think, with multiple requirements specified by the Food and Drug Administration. Simplifying the process it can be viewed as primarily two different tests. The first is adding bacteria and fungal microorganisms to samples of the solutions and after the manufacturers specified time period they must reduce the number of bacteria by 99.9% and the fungi by 90%. The second method of testing involves soaking the contact lenses in the microorganisms and then being disinfected as the manufacturer recommends. The lenses are then used to grow the bacteria and fungus on a special type of growth media. After a specific time period the number of live organisms are counted. These are referred to as colony forming units and less than 10 gives a passing grade. Tests must also be done to show that the solutions are not toxic or irritating to the eyes.
Bacteria chosen for testing in the past include Pseudomonas aerginosa, Serratia marcescens, and Staphylococcus aureus. The first two are in a category called gram negative bacteria and the third is gram positive. While most tropical and semi tropical climates show gram negative bacteria and fungal infections are more prevalent, temperate northern climates tend to have more gram positive bacterial infections. Pseudomonas is present almost everywhere in humid climates. While these three bacteria do cause a high incidence of contact lens related eye infections, there are numerous other bacteria that cause infections. While fungal eye infections are rare, Candida albicans and Fusarium solani are the two tested for. One of the recent outbreaks was caused by Fusarium.
We can’t test for every possible microorganism, the time and cost would be prohibitive. This is the best mix determined in the past. With Acanthamoeba being the organism resulting in the other recent outbreak it may be added in the future.
Reducing organisms to a level that the bodies immune system can handle is one assumption for test requirements. Many variables are left out. The age of a lens may effect how well bacteria adhere. The condition of the contact lenses case, the wearers personal hygiene, individual; variation in immune response, all factor in. The therapeutic dose of a disinfecting agent shows individual variation. Some bacteria mutate and become resistant to disinfectants and also can develop coatings on the lens to render the solutions less effective. Some microorganisms may become more common, virulent, or our daily exposure to them may increase for various reasons. This is probably the case with acanthamoeba. The use of antimicrobial hand soaps may result in mutations to bacteria that were not a problem for the eyes in the past. Incomplete use and under dosing of antibiotic treatment may result in the same problem. The microorganisms used for testing are standardized and not necessarily representative of the current existing strain of that microorganism. Even the culture media used is standardized and different from the environment the eye contact lens environment presents for the bacteria to grow in.
Rubbing a contact lens help remove surface films and debris that allow a the disinfecting solutions to work better. In the imperfect world of solution testing it is expected to help reduce eye infections.
The second change is more questionable to me. Solutions do have a lifespan when the disinfecting action drops below an effective level. They also could remain unopened until close to this date and then be used, resulting in usage past the time the solution was effective. Alternatively, once opened, the solution is subject to environmental contamination from bacteria that could exceed its capacity over time. The problem is putting two different dates on a bottle is confusing. Proper wording can help, but one glance in any refrigerator will likely reveal we all aren’t very good at the two date dilemma. Time will tell, but short expiration dates on all solutions might be a better solution (pardon the pun). Best of all would be a solution that changes into a horrible color after it has been open a month. Of course with teenagers, that unfortunately might be an incentive.
A number of years ago an outbreak of pink eye in a elementary school had all the moms frantic and half of the school would be missing in action shortly after the announcement was sent home. Those days were prior to the education parents and health care providers have been receiving in current times about preventive measures to help in ceasing the spread of pink eye. In the past if one child was infected by pinkeye it was not long before half the class ended up with it too. Now that personal hygiene is taught more extensively in the schools at an earlier age parents are becoming more aware of how to prevent further infection of pink eye at home. This has helped seclude outbreaks so they occur less frequently than previously. It is still not unheard of to occasionally see a major outbreak spread rapidly through a school. Pink eye can cause any parent concern when they see their child come home from school with a pink to extremely red eye. Hemorrhagic forms of pinkeye cause small amounts of blood to spread out over the white part of the eye and the appearance exceeds their actual capacity to damage eyesight. The first scare is eye damage. Thankfully, pink eye rarely causes any long-term eye vision damage and some types of pink eye can resolve without any treatment in a week or so.
Pinkeye, otherwise known as conjunctivitis is an inflammation of the conjunctiva that can be caused by infections, allergies, viruses, colds, bacteria, or a substance that irritated the eye leading to an infection. Just because some pink eye types will fade away without intervention, never risk a your childrens sight with that thought process; always seek out medical eyecare from your family Optometrist immediately. Some forms of pinkeye can be debilitating for up to a year. Other more serious eye diseases may look like pinkeye but indeed may be a very serious type of eye disease. Most schools will not let your child return to school unless you can show proof that you have seen one of the Eye Doctors in your area. Your Optometrist can give your child a clean bill of health when they feel like they are no longer contagious. Unfortunately, this is not an exact science but a reasonable enough guess to significantly reduce the spread of pinkeye today. Typically a child will need to be out of school for 3-4 days.
Newborns born with pink eye is generally due to the mother passing on an STD (sexually transmitted disease) to the infant through the birth canal and can be serious if not caught at onset. Doctors have become more then vigil in checking birth mothers prior to birth for STDs that can cause serious side effects in their newborn well prior to delivery and treat those conditions during her term. Pinkeye presents with symptoms of eye discomfort, commonly relayed as feeling as if sand is in the eye. It can commonly cause the child to wake in the morning with a thick crust that seals the lids together resulting in the need of a warm towel to soften the mucus to be able to open the eye comfortably. Other common symptoms are sensitivity to light, itchiness, and excessive tearing. Pinkeye caused by bacteria or a virus are highly contagious and can be passed through touching an infected child, touching something an infected child has touched, coughing, and sneezing.
To prevent the spread of pink eye keep your child out of school or daycare until your doctor or Optometrist give the go ahead for them to return. Teach your children to wash their hands frequently and explain to them why it is so important. Washing hands while singing the happy birthday song twice to themselves is a good way to teach them correctly. Also, teach your children not to share personal care items with another student or child as well as if they are aware that another child is ill or has a case of pink eye. Do not use or touch anything belonging to that child until they have been given a clean bill of health. This is especially true in young contact lens wearers; your child should never try on another persons lenses or borrow their case or contact lens solutions. In your home, wash pillowcases regularly, especially anytime your child is ill as well as other bedding and linens. If your child has a case of the pink eye, separate their towels and washcloths items from the rest of the families and wash their items in hot water. If your child is at risks of coming down with pinkeye due to allergies, limit their pollen contact by keeping your child inside on heavy pollen days, keep your home closed up during them periods, dust and vacuum daily, and avoid subjecting your child to any other free radicals in the air such as cigarette smoke, smog, car exhaust, etc. If you suspect your child may have a case of the pinkeye or a school nurse has sent your child home, contact a qualified Optometrist to get treatment as needed for your child.
Alternative treatments for pinkeye in under developed countries include topical povidone-iodine (betadine) which is effective against most bacterial conjunctivitis at a fraction of the cost of standard antibiotic prescription eye drops. Povidone is sometimes used by optometrists to treat EKC, a special severe from of viral conjunctivitis. However, it does not appear to be a treatment for most viral forms of conjunctivitis. Homeopathic remedies include Similasan Pink Eye Relief eye drops. Similasan 2 Allergy Eye Drops have had one small study showing effectiveness and they do seem to work well for some patients with milder forms of allergic conjunctivitis. Any over the counter eye drop treatments should be used under medical supervision as some drops can induce angle closure glaucoma in susceptible patients. There have been cases where individuals have gone blind from self treating with over the counter eye drops. Chronic dry eyes can make you susceptible to recurring bouts of conjunctivitis. Treatment of dry eyes may be a very good preventative measure for chronic pinkeye
Red eyes and swollen eyelids upon awakening in the morning are common eye problems that many people suffer from with vague diagnoses usually of dry eyes or eye allergies. Sometimes just having the eyes dilate in the darkness can precipitate attacks of angle closure glaucoma in patients who have risk factors for this type of glaucoma. Frequently eye allergies are the cause, aggravated by a low level of tears in dry eyes. The lower level of tears means allergens your eyes are exposed to at night are not as diluted as a normal eye and they have a greater effect. Open windows in allergy season allow more pollen inside, and pets sleeping on pillows during the day can also add to the problems. Sleep apnea along with floppy eyelid syndrome can cause your eyes to be open and dehydrate while you sleep. A low-grade infection of the eyelid margins with staphylococcus bacteria is another common cause of swollen eyelids in the morning. Many other conditions can cause red, swollen eyes in the morning. However, there are normal aging factors that predispose you do this condition that is found more frequently in women than men.
As you sleep at night the normal tear film is not being pumped out through the tear ducts and spread across the eyes by the wiper like motion that occurs with normal blinking. In the REM states of sleep you do have some blinking occurring but overall the eye is a static environment while you sleep trapping bacteria on the surface of the eye. The eye has it’s own immune system that is ramped up at night to compensate for this increase in bacteria. The result is a state of mild inflammation is almost everybody. As the body ages and the eyes become dryer the relative concentration of bacteria and bacterial toxins increases making a more noticeable immune response. With menopause, there is a drop in hormone levels in both men and women. The androgen hormone that is more commonly associated with men seems to be the largest factor in dry eyes in women. The incidence of dry eyes in women is at least 3-4 times more commonly reported and also increases with age.
The eyelid anatomy contributes to eyelid swelling. There is a barrier to fatty tissue in the upper eyelid that degrades with age and fatty tissue enters into the lid causing it to droop all of the time. The eyelid tissue looses its elasticity with age and thins resulting in more susceptibility and visibility of swelling. Sleeping at night without blinking with the buildup of inflammation described above causes swelling in the adjacent eyelid tissue. Since you are lying down with a slight elevation to your head there is reduced drainage of fluid within the lymph system and fluid accumulates on the lower eyelid. This will reduce throughout the day if the cause is chronic low-grade inflammation overnight.
The first step in treatment is a visit to your eye doctor to rule out any other more serious causes such as heart conditions, kidney problems, obstructive sleep apnea,glaucoma, or medication side effects. Your optometrist may find other causes as outlined above that need to be treated. After that, there are a few alternative therapies you can try to help.
1. Reduce alcohol and salt consumption as they contribute to water retention
2. Try some form of cool compresses in the morning for 5-10 minutes.
3. Exercise early in the morning to stimulate the circulation.
4. Be glad your vision is good and your eyes are essentially healthy!
Your Optometrist may have new guidelines for contact lens solutions in the future. The Food and Drug Administration has decided to review the testing procedures for contact lens solutions against the organism acanthamoeba. Acanthamoeba is a type of microorganism called a protozoa that thrives in moist environments and can be found almost everywhere, although it has a much higher incidence in regions with humid, warmer climates like the states in the South Eastern part of the country. Areas with low humidity like Colorado have a lower overall incidence. It is very common in most soil in addition to fresh water. Most forms of acanthamoeba do not effect the eye but one can with serious consequences. It is not unknown to find acanthamoeba when culturing contact lens cases of patients that are currently show no signs of infection. The eye has it’s own immune system including substances secreted in the tear film that can keep most infections from gaining a foothold. Contact lens wearers who over wear their lenses and use their solutions inappropriately are more susceptible to any type of eye infection. Over wear disrupts the tissue on the front of the eye, the corneal epithelium. This disruption allows organisms like acanthamoeba to enter into the eye tissue and multiply. The Centers for Disease Control and Prevention (CDC) confirmed 138 cases of Acanthamoeba infection of the corneal tissue (keratitis) in 35 different states during 1997. This type of infection has shown an increasing trend in recent years after slowing in the past when homemade saline solutions were discontinued. The increasing incidence may be related to the tendency to decrease or eliminate chlorination in drinking water although there are also many more people choosing contact lenses for their vision correction, and multipurpose solutions that are ineffective against acanthamoeba have become the contact lens care systems of choice. More contact lens wearers also mean more patients leaving their contact lenses on while enjoying a soak in a Jacuzzi. Chlorination of hot tubs is often inadequate; especially considering how frequently people overload the suggested capacity for occupants. Acanthamoeba exists in two forms and the cyst forms are very resistant to treatment. Unlike the active form the cysts can survive under extreme conditions of chemicals and large temperature ranges. Eye Doctors find acanthamoeba keratitis infections are difficult to treat and even with the care of the best corneal specialists they may still result in blindness and require corneal transplants. Acanthamoeba infections are almost unknown in the United States in patients who replace their lenses daily or don’t wear contact lenses. Hydrogen Peroxide contact lens cleaning systems kill the cyst form when used as directed. Chlorhexidine and heat systems will also kill the cyst form. Chlorhexidine is an older preservative fairly toxic to the corneal eye tissue and had a high incidence of allergic reactions when it was commonly used in contact lens solutions in past years. Heat disinfection bakes deposits on the lenses and was frequently skipped when it was the most common form of contact lens disinfection. All of these older cleaning systems have lower compliance rates and I believe 100% compliance with less effective solutions is better than 95% compliance with solutions having lower kill rates, especially considering the most common bacteria that cause keratitis are usually eliminated by multipurpose no rub solutions when they are used as directed. Using no rub solutions and adding back in a rubbing step on most days is a compromise that is probably the best system we have today. However, none of the multipurpose solutions have the capacity to effectively destroy acanthamoeba cysts. Hopefully the FDA review will help fill this gap in the future. In the interim the following guidelines like the FDA suggestions should help prevent most acanthamoeba eye infections.
(1) See your eye care professional immediately if you experience symptoms of eye infection such as redness, pain, excessive tearing, increased light sensitivity, blurry vision, and/or sensation of something in the eye.
(2) Wear and replace your lenses according to the schedule prescribed by Optometrist.
(3) Remove your lenses before any activity involving water, including showering, using a hot tub, or swimming.
(4) Wash your hands with soap and water for about 20 seconds, and dry them before handling your lenses.
(5) Clean your lenses according to the manufacturer’s guidelines and instructions from your eye doctor.
(6) Use fresh cleaning or disinfecting solution each time your lenses are cleaned and stored.
(7) Never use saline solution and rewetting drops to disinfect your lenses. Neither solution is an effective or approved disinfectant.
(8) Ask Your Eye Doctor about using a rubbing step with adequate rinsing even with no rub solutions. Rubbing the lenses removes surface deposits and has been shown to improve the disinfecting efficacy.
(9) Store your lenses in the proper storage case.
(10) Rinse your storage case with sterile multipurpose contact lens solution (never use tap water-it is a primary source of acanthamoeba) and leave the storage case open to dry after each use.
(11) Replace storage cases at least once every 1-2 months-you can usually find a case packaged with solution at no added cost.
Acanthamoeba is still a rare infection but hopefully will become unheard of in the future.
Dr David Kisling,O.D.
Fort Collins, CO. VSP Providor (Vision Service Plan))



