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TobraDex

TobraDex is a popular prescription medication marketed in the United States by Alcon Labs. The active ingredients are Tobramycin 0.3% (an antibiotic) and Dexamethasone 0.1% (a corticosteroid). TobraDex is a trademark of Alcon Labs. It is prescribed for a wide spectrum of bacterial eye infections.

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Better safe than sorry
From Optometric Management, 1/1/03 by Sherman, Jerry

In cases of "routine" keratitis that don't improve think fungal infection to avoid litigation.

Fungal eye infections are uncommon and often serious, but rarely considered unless a patient presents with a telltale history such as a tree branch-induced eye abrasion. Without such a history highly suggestive of fungal involvement, it's rare for any ophthalmic clinician to diagnose a fungal infection on the first or even the second visit.

So how many chances should a clinician have to consider a fungal infection, culture it to confirm his suspicions and treat it appropriately? To meet the standard of care, a timely referral to a corneal specialist is equally acceptable to a timely diagnosis, but how do we define timely? Consider the following case.

Making an initial diagnosis

A 76-year-old white female, who we'll call June, presented to her O.D. with irritation and redness in her right eye for the past week. The doctor had provided general care and contact lens care to the woman for more than a decade. His records indicated a previous bout of blepharoconjunctivitis that responded to tobramycin about one year earlier.

On this visit, June's corrected visual acuity (VA) was reduced in the affected right eye to 20/50-- with no improvement with pinhole. The slit lamp exam revealed an area of stromal haze/edema in the inferior cornea of the right eye. He noted the anterior chamber as clear without cells or flare and he observed no discharge. The diagnosis was questionable resolving toxic keratitis associated with overwear of the contact lenses.

The doctor instructed June to discontinue wearing contact lenses and prescribed ciprofloxacin (Ciloxan) antibiotic eye drops for use q.i.d. along with tobramycin 0.3% and dexamethasone 0.1 % (TobraDex) and told her to return in three to four days or sooner if needed.

Getting worse

Three days later June returned and the record reveals that her eye had been feeling much better until earlier that day when she noted a decrease in vision in her right eye. Corrected VA was 20/60- OD. The slit lamp exam revealed an increased area of stromal haze and thickening in the right eye with minimal staining. The anterior chamber was still free of cells and flare.

The O.D. assessed stromal keratitis with minimal inflammation of questionable etiology and noted a probable toxic reaction to ciprofloxacin. He discontinued the ciprofloxacin and initiated tobramycin drops q.i.d. On his chart, the treating O.D. noted an attempt to arrange a consult with corneal specialist Dr. N but that he couldn't reach him.

June returns again

June returned to her optometrist's office two days later and reported that her eye felt much worse and that her vision was further reduced. Corrected VA was now 20/200 with no improvement with pinhole and still 20/20 OS.

The slit lamp exam revealed a larger area of stromal haze/thickening and the O.D. couldn't view the anterior chamber. He noted stromal keratitis of questionable etiology not responding to the topical antibiotics and called Dr. N again. He arranged for a consult that night.

The specialist takes a turn

According to Dr. N's records, the history and chronology were consistent with the referring optometrist's records. However, VA was now hand motion in the right eye. Dr. N diagnosed a corneal ulcer OD, injected gentamicin and began treating with tobramycin, vancomycin and Bacitracin ointment at night. He saw June the next day and noted similar clinical findings.

For the first time, he noted, "Rule out fungal etiology" and added the antifungals natamycin and amphotericin to the previous medications. Dr. N then referred June to a major eye hospital in the closest major city, where they admitted her.

The hospital makes an effort

A day later, the hospital staff noted hyphae on a previously obtained Gram stain. June's VA was counting fingers OD. The slit lamp exam revealed a circular stromal infiltrative ring-like pattern with feathery edges. Goldmann Tonometry was 32, 35 OD. A B-scan ultrasound was unremarkable.

The hospital's corneal specialist performed a second culture, which revealed no growth, and discontinued the antifungals but not the antibacterials. Intraocular pressures (IOPs) were now measured at 42 mm Hg OD and the specialist added brimonidine tartrate (Alphagan) to the dorzolamide 20 mg and timolog 5 mg per ml (Cosopt), which he prescribed a day earlier to control June's elevated IOPs.

Several days later, the hospital obtained corneal biopsies and pathology revealed fungal elements. Fortunately, a suitable donor cornea was available, so a surgeon performed a total penetrating keratoplasty (PK). A pars plana vitrectomy followed with injections of both vancomycin and amphotericin B.

The surgeon performed a second surgical procedure within the next week, which included anterior chamber aspirates for cultures, lens extraction and additional intraocular infections, as well as another PK. He performed yet a third PK several days later along with drainage of choroidal effusions and infusion of silicone oil.

Within a month, the hospital sent a letter to Dr. N that read, "Despite our efforts, the right eye has gone phthisical as a result of fungal keratitis/endophthalmitis and we've recommended an implant and scleral shell."

June retained an attorney who initiated litigation against her optometrist because of the loss of her eye.

Analyzing the situation

Regarding the allegations of malpractice on the part of the O.D., consider these points: Should the O.D. have diagnosed the fungal keratitis? Should he have referred June sooner? Would the outcome have been any different if he'd done either of the above?

As I mentioned earlier, fungal eye infections are rare and, in my experience, difficult to diagnose on the first visit unless the history reveals trauma with plant matter or if you've been treating the patient for a long time for a bacterial infection but it hasn't improved.

Based on the above, the O.D. had no reason to conclude that a fungal infection was the etiology. The vast majority of like clinicians under like circumstances would've also failed to diagnose a fungal infection at first and hence the O.D. met the existing standard of care.

When June returned to her O.D. with worsening symptoms and clinical findings, a referral to a corneal specialist was rightly considered. Regrettably, Dr. N wasn't available. Most clinicians at this point still wouldn't consider a fungal infection as the cause. Many would similarly have concluded that perhaps the ciprofloxacin wasn't working or was resulting in a toxic reaction. A change to tobramycin was reasonable at this point and didn't breach the standard of care.

When the patient returned several days later with worsening signs and symptoms, a referral to a specialist was certainly indicated and was accomplished the same day. The referral was entirely appropriate and clearly met the standard of care.

When Dr. N examined June for the first time that same day, he didn't conclude that her worsening condition was caused by a fungal infection. He did add antibiotics (including the strongest one available, vancomycin) as treatment for a presumed bacterial infection. It wasn't until he evaluated June the next day that he considered and initiated treatment for a fungal infection.

In spite of exemplary care at a major New York hospital initiated the next day, no medical treatment or surgical intervention could save June's eye. This is of course unfortunate but not rare in fungal infections.

Sharing an opinion

I must conclude that June had a bad bug but not bad doctors. In my opinion, her optometrist met the standard of care in his evaluation, treatment and referral during the three visits in question. Even if he had reached Dr. N on the first try and if Dr. N had evaluated June the next day, it's far likelier than not that the outcome of this case would have been the same.

Because Dr. N didn't diagnose the infection as being caused by a fungus on the first visit, there's no reason to believe that he would've reached that diagnosis several days earlier. In fact, the correct diagnosis would've been more difficult because the significant worsening noted by the O.D. didn't occur until the third visit. In my professional opinion, the O.D., as well as all of the other doctors, aren't culpable of malpractice.

June's attorney still hadn't found an expert witness to testify against her O.D. (I refused to serve as an expert witness for the plaintiff because of my perceived lack of merit of the case). Without such an expert, the courts will likely drop the case.

Learn from others' mistakes

Although the O.D. most likely met the standard of care, this case is a lesson for all of us. Consider a fungal infection as soon as antibiotics appear ineffective. Also consider obtaining a culture or a consult. You could even begin anti-fungal therapy while you wait for the results of the culture or for a second opinion.

Fungal eye infections are rare, but less than timely diagnosis and treatment in such cases may lead to malpractice litigation.

Dr. Sherman practices at the Eye Institute and Laser Center in Manhattan and is a distinguished teaching professor at the SUNY College of Optometry. To protea the anonymity of the individuals involved in this case, we have not used their real names.

Copyright Boucher Communications, Inc. Jan 2003
Provided by ProQuest Information and Learning Company. All rights Reserved

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