Article Date: 7/1/2008

Optometrists Comment on FDA Solution Recommendations
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Optometrists Comment on FDA Solution Recommendations

DID THE FDA GO FAR ENOUGH?

■ Last month, a panel of eyecare experts recommended that the Food and Drug Administration (FDA) require contact lens solution manufacturers to test their solutions against more types of bacteria and fungi. The panel also recommended that manufacturers change the information that accompanies contact lens care solutions to include:

► warnings not to reuse solution;

► discard dates for lenses;

► rinse and rub instructions for all solutions;

► recommendations to replace lens cases frequently;

The panel met in response to solution-related eye infections that were reported to the FDA through the last two years. Overall, O.D.s gave a thumbs-up to the recommendations.

"A number of the suggested labelings will go a long way to reinforce the dialogue we try to have with our patients every time they are in for their annual contact lens evaluation," says Jay Petersma, O.D., Johnston, Iowa. "Over the past few years, we have made a concerted effort to remind our patients to never reuse their solution or just top-off the case, to replace the lens case every six months, and to rub and rinse the lenses clean after removal each day. It's been amazing just how many patients were negligent in one or more of these areas of lens care."

Scientists with the FDA claimed that 80% of infection problems associated with lens solutions are caused by users who don't follow directions.

Pamela Miller, O.D., J.D., of Highland, Calif., agrees with the FDA's direction. "As a private practitioner who has a significant number of contact lens patients, I personally support the reinforcement by the manufacturers of the instructions I emphasize with our patients," she says. "Not only would this help support our position legally, but it would help protect our patients as well. Reinforcement of basic contact lens care is a big plus, and it helps protect the patient who either forgets or who is never told some of the basic precautions they should be taking to maximize their ocular health. It should be clearly understood that manufacturer reinforcement is not in lieu of instructions, but rather a supplement to basic care information and knowledge."

"It seems the no-rub advocates have all gone into hiding."

— Dr. Hom


Keeping Patients Safe in CLs
Frank D. Fontana, O.D., of St. Louis, offers the following advice to eyecare professionals to facilitate patient compliance with contact lens solutions and healthy contact lens wear:

1 Review your personnel's training instructions to patients.
2 Give written and pictorial handouts to new and old patients.
3 Re-read package inserts of all solutions that you dispense or recommend.
4 Follow FDA-approved solutions and their recommended guidelines of use to the letter. (No off-label uses!)
5 MOST IMPORTANT: ALWAYS EMPHASIZE TO YOUR PATIENTS THE IMPORTANCE OF HAND WASHING BEFORE HANDLING LENSES.

Will consumers adjust?

The number of eyecare professionals (ECPs) that advocate a no-rub regimen for contact lenses has dwindled. "I used to call it the ‘no rub’ debate," says Milton Hom, O.D., of Glendora, Calif. "You can call it debate when there are two opposing sides. Not any longer. It seems the no-rub advocates have all gone into hiding. A couple of years ago, the data showed 72% of practitioners were for rubbing and rinsing. This year, when I have polled audiences for their views, I would say the number is now 90% in favor of rubbing and rinsing."

While the practitioners love rubbing and rinsing, "the patients hate it," adds Dr. Hom.

Sheldon Kreda, O.D., of Lauder-hill, Fla., agrees. "The original purpose of no-rub solutions was to promote compliance by balancing ease of use against efficacy," he says. "As lens care becomes more complicated, patients will choose either non-compliance or single use lenses."

Issues omitted and unanswered

Dr. Petersma says the panel did not go far enough. "A glaring omission is a recommendation to visit an eye doctor annually to ensure good corneal health," he says. "This is a golden opportunity to reinforce the importance of proper eye care. It's analogous to the dental exam recommendation that's been a part of every toothpaste tube and ad for over 40 years."

Dr. Hom questions the efficacy of a rub regimen to eliminate Acanthomoeba keratitis (AK), a rare eye-infecting parasite. He cites researcher Philip Morgan, MCOptom, Ph.D., who states that rubbing and rinsing "reduces infection for lenses in general."

"A glaring omission is a recommendation to visit an eye doctor annually …"

— Dr. Petersma

"But the definitive Joslin paper found a p value of 0.6 as a risk factor for AK," Dr. Hom says. "Not statistically significant, but a directional trend. I think the jury is still out as to whether rubbing and rinsing is an AK risk factor."1

1. Joslin CE, Tu EY, Shoff ME, et.al. The association of contact lens solution use and Acanthamoeba keratitis. Am J Ophthalmol 2007 Aug;144(2):169-180.

Here's a Low-Cost Way to Achieve Growth During a Slow Economy.

ACTIVATE INACTIVE PATIENTS

Bob Levoy, O.D., Roslyn, NY

■ Of all the low-cost ways to achieve practice growth, none is more logical (or easy) than getting patients who haven't had a comprehensive eye examination in a year or more, to make an appointment.

Action steps: As a start, have a staff member call 25 randomly selected "inactive" patients, and simply explain:

"In reviewing our records, I see that you haven't had a comprehensive eye examination since (date). I'm calling you to see if you would like to make an appointment at this time."

That's it. No long explanation of why it's important. No reminder that visual anomalies and ocular disease can be present before noticeable symptoms arise; and certainly no scare tactics, sales pitches or "inducements" of any kind. Have your staff member keep everything low-key, and see how the patient replies.

Your staff member may learn that the patient has moved away or because of managed care or some other reason, is seeing another optometrist. Or, the patient may reply:

"I'm doing fine — and don't care to make an appointment at this time."

Let's just focus on what many receptionists have found to be a surprising number of patients who say:

"Has it really been that long?" (Two years?)

"I know it's been a long time. I've been meaning to call you."

"I've been waiting for you to call me."

Needless to say, any one of these replies can lead to an appointment.

Tested tip: After making the appointment, have your staff member ask the patient:

"Is there anyone else in the family for whom you'd like to make an appointment?"

Again, there'll be more "yes" answers than you might guess.

An important caveat: When designating a staff member to call, make sure she's "comfortable" doing it and truly believes it's in the patient's best interests. She'll get better results if she has this attitude.

Only a handful of favorable responses will more than warrant telephoning the rest of your inactive patients.

Bob Levoy's newest book is 222 Secrets of Hiring, Managing and Retaining Great Employees in Healthcare Practices published by Jones & Bartlett. E-mail him at b.levoy@att.net.

Editor's Note: In the article "Photographing The Fundus" of the May 2008 issue, the phone number for Visual Pathways should have read (928) 778-5002.

Thong Gone Wrong?

WOMAN SUES VICTORIA SECRET FOR EYE INJURY

■ Macrida Patterson, a 52-year-old, Los Angeles traffic officer, is suing lingerie-giant Victoria's Secret for more than $25,000, alleging the company manufactured and designed a defective product — namely a thong — that caused damage to her cornea.

Specifically, in May 2007, Ms. Patterson says she was putting on the alleged faulty undergarment in the locker room after her shift when one of the two staples affixing a metal heart pendent as part of the thong's waistband, "popped" into her eye. In late June, Ms. Patterson's lawyer, Jason Buccat, told Today's Meredith Vieira that this resulted in three cuts to her cornea, which required topical steroid use.

Victoria Secret did not return our request for comment.

HEALTH Notes
  • Rosiglitazone maleate, an oral peroxisome-proliferating activate receptor gamma agonist and oral insulin sensitizing agent appears to delay proliferative diabetic retinopathy onset by almost 60%, possibly due to its antiangiogenic activity, says a study in the June's Archives of Ophthalmology.

  • A high consumption of omega-3 fatty acids was linked with a 38% decrease in the risk of late age-related macular degeneration (AMD), and eating fish at least twice a week was linked with a reduced risk of both the early and late stages of AMD, according to a systematic review and meta-analysis study in June's Archives of Ophthalmology.

  • Triamcinolone acetonide injectable suspension 80mg/mL (Trivaris, Allergan), a synthetic glucocorticoid corticosteroid with anti-inflammatory action, has received Food and Drug Administration (FDA) approval for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions that can result in vision loss that are unresponsive to topical corticosteroids. Full prescribing information is available at www.allergan.com.

  • Children not only view their spectacle-wearing peers as "smarter," but "more honest" than other children, says a study in May's Ophthalmic and Physiological Optics.

  • Difluprednate ophthalmic emulsion 0.05% (Durezol, Sirion Therapeutics) received FDA approval for the treatment of postoperative ocular inflammation and pain. The drug is a topical steroid. You can find full prescribing information at www.fda.gov/cder/foi/label/2008/022212ilb.pdf.

Ciba Vision Product News

COMPANY REPORTS FOUR NEW DEVELOPMENTS

■ CIBA Vision released the following information:

► The Air Optix Aqua silicone hydrogel monthly replacement daily and extended wear (up to six nights) lens features a proprietary moisture agent, lotrafilcon B and a smooth surface with wettability and deposit resistance, the company says. It has a Dk/t of 138, a 8.6mm base curve, a 14.2mm diameter and parameters from -0.25D to -8.00D in 0.25D steps; from -8.50D to -10.00D in 0.50D steps and from 0.25D to +6.00D in 0.25D steps.

► The Air Optix for Astigmatism silicone hydrogel monthly replacement daily and extended wear (up to six nights) lens is now available in a -1.75D cylinder with axes around the clock in 10° steps. The lotrafilcon B lens is available from plano to -6.00D in 0.25D steps, has a dk/t of 108 @ -3.00D -1.25 D × 180, a 8.7mm base curve and a 14.5mm diameter.

► The company is proactively recommending that the regimen for its Aquify Multi-Purpose Solution (MPS) now include a rub, rinse and five-minute overnight soak. CIBA Vision will officially implement these changes on the Aquify packaging after consulting with the FDA.

► The Clear Care and Aquify MPS lens care products are now available in two-ounce travel-size bottles. Both products, which include a lens case, comply with the Transportation Security Administration (TSA) and meet the liquids in carry-on baggage requirements, CIBA Vision says.



Optometric Management, Issue: July 2008