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February 2004

News in Review

ROP: New Parameters for Treatment

Patients Records Are on the Line ... er, Online

Sutures Made Easy

Patient Care: One Thing Leads to Another

ROP: New Parameters for Treatment
A large clinical study on a vexing problem in pediatric ophthalmology has yielded a new treatment algorithm. Adopting the model will prevent much unneeded laser treatment for retinopathy of prematurity while protecting the vision of infants with the most aggressive forms of the disease, the investigators conclude.1

The Early Treatment of Retinopathy of Prematurity (ETROP) randomized trial found that waiting until the risk of retinal detachment reached 50 percent—the “threshold” set in Cryo-ROP, an earlier study—increased the incidence of unfavorable visual outcomes in the first year of life by a third, from 14.5 percent to 19.5 percent.

“Now physicians will have a better idea of when to be aggressive with treatment,” said George S. Ellis Jr., MD, president of the American Association for Pediatric Ophthalmology and Strabismus.

“Clinically, it will be prudent for individuals screening for ROP to know the new guidelines for when to treat. I do not think that most of the ROP treaters and screeners have been treating earlier than the original Cryo-ROP thresholds, but now they will if the word gets out,” Dr. Ellis said.

But trying to use the complicated, computer-based risk assessment tool (RM-ROP2) developed for ETROP wouldn’t be practical for clinicians, the investigators write. It also produced much unnecessary treatment in eyes that otherwise would have had a favorable visual outcome, they acknowledge.

To reduce this risk and give clinicians a practical decision-making tool, the researchers recommend basing treatment decisions on criteria drawn from the International Classification of Retinopathy of Prematurity system. Peripheral retinal ablation should be considered for any eye with type 1 ROP, defined as:

  • zone 1, any stage of ROP with plus disease. (Plus disease is defined as at least two quadrants, usually six or more clock-hours of dilation and tortuosity of posterior retinal blood vessels.)
  • zone 1, stage 3 ROP with or without plus disease.
  • zone 2, stage 2 or 3 ROP with plus disease.

Serial exams should be performed on eyes with type 2 ROP, which the researchers defined as:

  • zone 1, stage 1 or 2 ROP without plus disease.
  • zone 2, stage 3 ROP without plus disease.

“Using the clinical profile of which children have type 1 (high risk) and which ones have type 2 (moderate risk) ROP will help to keep treatments to a minimum while identifying those infants who really need the early intervention,” Dr. Ellis said.

Amid wide praise for the study, editorialist Alistair R. Fielder, FRCP, FRCOphth, of Imperial College London, sounds a note of caution. “The diagnosis of plus disease, especially if mild, is far from easy and remains one of the least robust aspects of ROP diagnosis,” Dr. Fielder writes in the same issue of Archives of Ophthalmology.2 But digital image analysis of retinal photographs in the future might make diagnosing plus disease easier, he adds.

“We really won’t know the visual outcome of the early treatment until these children have grown for several years,” said Dr. Ellis. “It is encouraging that the outcome measures noted do show the benefit of early treatment.”

1 ETROP Cooperative Group. Arch Ophthalmol 2003;121: 1684–1694.
2 Ibid. pp. 1769–1771.

HIPAA Compliance
Patients Records Are on the Line ... er, Online
With all the controversy over federal patient-privacy rules of the last year, the idea of confidential medical records appearing on the Internet might seem preposterous. But administrators at the University of San Francisco Medical Center received a stunning demonstration last fall of how downright easy it would be for that to happen.

“It’s a real problem. There is no way to control how medical transcription contractors and subcontractors are controlling the information a hospital or physician sends them,” said Stephen A. Kamenetzky, MD, a St. Louis ophthalmologist who serves as an Academy spokesman on patient privacy issues.

The UCSF situation offers a lesson in the potential drawbacks of globalization for American companies that cut their labor costs by moving information-related tasks overseas. As reported by David Lazarus in the San Francisco Chronicle, the story went like this:

In October, UCSF Medical Center officials were startled at an e-mail they received from Pakistan. A woman there named Lubna Baloch warned, “Your patient records are out in the open . . . so you better track that person and make him pay my dues.”

Ms. Baloch complained that a private medical-transcription subcontractor in Texas owed her hundreds of dollars for her work transcribing UCSF records—and she threatened to place private, patient files on the Internet if UCSF didn’t help her get the money. To prove she meant business, the woman attached some medical records to the e-mail.

According to Mr. Lazarus, the UCSF work wound its way from a private transcribing contractor in California, to a subcontractor in Florida and then to a second subcontractor in Texas before being outsourced overseas to the Pakistani woman. By the time the job reached Pakistan, the woman doing the work was receiving 3 cents per line—out of the 18 cents per line that UCSF paid the original contractor. The Florida subcontractor eventually paid the Pakistani woman what she was owed, and Ms. Baloch sent UCSF an e-mail taking back her threat.

The transfer of transcription work overseas happens in about 10 percent of all U.S. medical transcription, the American Association for Medical Transcription told the Chronicle—so the precedent set by this successful extortion case isn’t one that medical privacy experts are taking lightly.

But the solution to this problem remains unclear, said William Sarraille, JD, a medical privacy expert who spoke at the Academy’s 2003 Annual Meeting. Some states are considering laws to ban the use of overseas transcriptionists, he said.

“The reaction to ban by statute the use of overseas’ contractors misses the point that any subcontractor—no matter where located—can fail to meet the obligations imposed by law,” Mr. Sarraille said. “The issue here is that a business associate is supposed to ‘downstream’ its obligations to any subcontractor that it selects.”

How vulnerable might U.S. ophthalmic institutions be?

At the University of Miami, the Bascom Palmer Eye Institute is feeling safe. “Bascom Palmer does not send out any transcription,” said marketing director Marla Bercuson. “We have staff that does that internally.”

In Baltimore, officials at the Wilmer Eye Institute declined to be interviewed. “I’m told that Wilmer does send some records to an outside contractor, but the transcription work is done domestically,” said Karen Blum, assistant director of media relations for the Johns Hopkins Medical Institutions.

In truth, hospitals and physicians have very little control over what happens when they outsource transcription work to save money, Dr. Kamenetzky said.

“In this case, this was the third subcontractor. So, in your contract with whomever you hire to do this, you need to establish a clear chain of custody so you’re aware of where this information is going and how it’s going to be used,” he advised. “And in some cases you might want to put language in it expressly prohibiting subcontracting without permission.”

In the Pipeline
Sutures Made Easy
Two ophthalmologists in Chicago have what they think is a very good idea indeed: An ophthalmic bioadhesive composite that combines the strength of sutures with the ease of a surgical glue.

In a paper published last fall,1 Jeffrey N. Bloom, MD, and Mark T. Duffy, MD, PhD, reported combining a scaffold of poly(L-lactic-co-glycolic acid) with an adhesive made from bovine serum albumin and indocyanine green. The material—which looks a little like laboratory filter paper—can be made sticky when it is activated with a diode laser.

“This technique offers an alternative to the use of sutures in surgery,” said Dr. Bloom, director of pediatric ophthalmology and adult strabismus at the University of Illinois, Chicago. “The key is the synergy obtained by combining the scaffold with the adhesive.”

In tests with freshly harvested animal tissue, the adhesive scaffolding appears to be strong enough to use for everything from corneal repairs to strabismus surgery, the paper reports. The researchers have also tested this biodegradable composite in nonocular tissues.

“In all instances where we have tested this in vitro, we achieved a tensile strength, at least—if not more than— that of a suture repair,” said Dr. Duffy, an oculoplastic surgeon and director of the department’s residency program. “Subsequent in vivo studies have shown that the scaffolding increases the tensile strength of wound repairs significantly more than sutures or adhesive alone.”

The two ophthalmologists, along with biomedical engineers in Indiana, have formed a company, Advent Surgical Innovations, to try to develop the technology for clinical use. Current work includes use of adhesive composites that do not require laser activation.

1 Arch Ophthalmol 2003; 121: 1591–1595.

Patient Care
One Thing Leads to Another
When someone in your examination chair shows a puzzling visual loss, a good look at the latest additions to the patient’s medicine cabinet is in order, according to ophthalmologists who study drug side effects.

This point was driven home last fall, when a Minnesota ophthalmologist, Edwin H. Ryan Jr., MD, reported that a common class of oral diabetes drug can cause diffuse macular edema and a lingering loss of visual acuity. And in January an Oregon group documented 115 cases of acute, secondary, angle-closure glaucoma caused by the antiepileptic drug topiramate.1

At the Academy’s Annual Meeting, Dr. Ryan reported on 30 diabetic patients who developed macular edema while taking thiazolidinedione (TZD) drugs to lower their blood-sugar levels from type 2 diabetes. His larger case review in 205 type 2 diabetics in his practice found that at least 2.4 percent, and perhaps as many as 3.6 percent, had macular edema associated with systemic edema from these drugs. The two TZDs on the market in the United States are rosiglitazone maleate (Avandia) and pioglitazone hydrochloride (Actos).

Among the 11 patients Dr. Ryan has followed closely, peripheral edema and weight gain resolved quickly after TZD discontinuation. The macular edema cleared within six months to two years, with or without laser treatment. However, in most cases that did not lead to visual improvement, Dr. Ryan said.

In the topiramate paper, the group at the Oregon Health & Science University used the records of their National Registry of Drug-Induced Ocular Side Effects ( to document a quintupling since 2001 in the number of reports of acute, bilateral, angle-closure glaucoma caused by topiramate. This was possible because ophthalmologists have embraced the registry, said director Frederick W. “Rick” Fraunfelder, MD, assistant professor of ophthalmology at OHSU.

“In the last year we have entered 15,000 case reports of eye side effects into our database,” Dr. Fraunfelder said. “We’re getting 5,000 to 10,000 hits per month to the Web site.”

In 2003, the registry reported on scleritis caused by bisphosphonates given to prevent osteoporosis2,3 and on corneal abrasions caused by an herbal lice shampoo.4 The group expects to publish further papers this year showing ocular problems associated with:

  • the antihistamine cetirizine hydrochloride (Zyrtec) in
  • the antipsychotic quetiapine fumarate (Seroquel) and
  • the dermatologic drug isotretinoin (Retin-A).

1 Fraunfelder, F. W. et al. Ophthalmol 2004;111:109–111.
2 N Engl J Med 2003;348(12):1187–1188
3 Am J Ophthalmol 2003;135(2):219–222.
4 Arch Ophthalmol 2003;121:1790–1791.

News compiled by Linda Roach.