International education a primary role of AAO Ethics Committee

This topic and others were discussed at the Bascom Palmer Institute’s Inter-American Course.

MIAMI — The American Academy of Ophthalmology’s Ethics Committee is working to educate surgeons and surgical residents about its ethical code, both in the United States and abroad, according to the committee chairman.

Charles M. Zacks, MD, discussed some of the common issues addressed by the committee here at Bascom Palmer Eye Institute’s Inter-American Course in Clinical Ophthalmology.

The committee was formed in 1979 and became officially active in 1984 after the U.S. Federal Trade Commission approved its code of ethics. The goals of the nine-member committee include creating an international dialogue on ethics, sharing ethics education and working with supranational societies in developing ethical codes, Dr. Zacks said.

The committee’s code of ethics is divided into three sections — principles, rules and administrative procedures.

The focus of the “principles” section is that each ophthalmologist must act in the best interest of the patient and must show compassion for the patient, respect his or her dignity, and practice truthfulness and confidentiality. The principles also state that unethical behavior of other surgeons should be discouraged.

The “rules” section outlines enforceable standards, Dr. Zacks said. He described several specific rules, including Rule No. 1, which states that the surgeon must be competent, and other rules governing informed consent, advertising and the impaired physician.

The “procedures” section describes the structure of committees, such as investigation or enforcement.

“The code of ethics is a living document,” Dr. Zacks said. “We respond to new developments with revisions and interpret the code and write advisory opinions when new issues come up. In rare cases, we will propose and draft new rules.”

The committee also has the primary role of educating and assisting the AAO in policy development as new issues arise.

Dr. Zacks said the ethics code is available on the AAO Web site, www.aao.org, and programs are available to assist with resident education.

The following items originally appeared as live coverage on OSNSuperSite.com. Look for expanded articles on some of these topics in upcoming issues of Ocular Surgery News.

Advanced surface ablation finding increasing role in refractive surgery

Surgeons are seeing “excellent” visual results and low degrees of pain using the advanced surface ablation procedures available for refractive surgery today, according to William B. Trattler, MD.

William B. Trattler

“I do think it is extremely safe and provides great vision with the ability to use it in advanced situations, such as post-LASIK. It is playing an increasing role in our armamentarium,” Dr. Trattler said.

Earlier versions of surface ablation were often painful for patients, but a number of approaches to reducing pain have been introduced, including preoperative use of Restasis (cyclosporine ophthalmic emulsion, Allergan), punctal plugs, topical anesthetics, oral medications and chilling the cornea with chilled saline, Dr. Trattler said. He also recommended placing a bandage soft contact lens on the eye postoperatively.

With deeper understanding and improvement in techniques, indications for surface ablation have also been expanded to include some patients who are not candidates for LASIK, he said, such as those with thin corneas, suspicious topographies or dry eyes, as well as those with previous LASIK flap complications.

Additionally, there are now a variety of techniques for removing the corneal epithelium, including brush, laser, manual scrape, alcohol-assisted laser epithelial keratomileusis and epi-LASIK, Dr. Trattler said.

He noted that surgeons should wait 3 to 6 months after LASIK before performing surface ablation for a residual error to give the flap a chance to “settle down.”

High myopes seek refractive surgery, weigh options

With recent media attention on advanced technologies for refractive surgery, high ametropes are increasingly curious to learn whether refractive surgery options are available for them, according to Terrence P. O’Brien, MD.

“We have to consider ethical principles for higher safety, especially with these elective procedures,” he said. “You must be careful to discuss the risks and benefits, especially the long-term risks. Our motto is primum non nocere — first, do no harm. That is true of these higher myopes to avoid complications.”

“As we consider patients with high myopia, we do not want to totally discount laser surgery,” he said, noting that the U.S. Food and Drug Administration has approved custom laser vision correction for myopia and myopic astigmatism and recently for higher degrees of myopia.

“The real fear factor you will hear about with higher ablations is the potential to create an unstable cornea,” he said. “If corneal thickness is insufficient, we clearly have to look at an alternative.”

Terrence P. O'Brien

Refractive lens exchange (RLE) is a surgical option often avoided, but its risks may be worth the potential rewards for highly myopic patients, Dr. O’Brien said. Advantages of RLE include avoiding corneal alterations and the risk of haze and poor contrast sensitivity that can occur with laser vision correction. It is also performed using familiar cataract surgical skills, he noted.

A small incision should be used for RLE to avoid inducing astigmatism, and low or no phaco power should be used for extraction of the soft lens. The capsule should also be polished to reduce the risk of posterior capsular opacification, he said.

Dr. O’Brien recommended using a foldable acrylic IOL with a diameter of 6 mm or greater.

“If one is going to consider this, the surgical technique should be modified to reduce risk,” he said.

Disadvantages of RLE include the risk of PCO, loss of accommodation and possible complications including vitreous loss, cystoid macular edema, endophthalmitis and rhegmatogenous retinal detachment.

An alternative to RLE is phakic IOL implantation, which has the advantages of excellent refractive results, fast recovery, preserved accommodation, reversibility and an unaltered cornea, he said.

“One of the problems with this is space” in high hyperopes, Dr. O’Brien said. “We know from anatomic studies that there is not a lot of space in these eyes, and with phakic IOLs there is often limited space.”

Complication rates can be reduced, not eliminated

Intraoperative complications during cataract surgery are inevitable, but there are steps surgeons can take before scrubbing that could help reduce their incidence, according to one surgeon.

Alejandro Espaillat, MD, a voluntary assistant professor of ophthalmology at Bascom Palmer Eye Institute, discussed approaches to minimizing cataract surgery complications. He likened surgery to driving in the rain.

“You have to do a lot of maneuvers to prevent accidents,” he said through an interpreter. “It’s the same thing in surgery. The issue is you have to have good safety, and you need to learn how to drive in difficult conditions.”

Dr. Espaillat said he makes sure the patient’s head and arms are restrained to ensure that the patient does not move during surgery.

“Also make sure you are in the correct position,” he said. “We sit temporally because you have better room there.”

It is also important to confirm with the technician that the instruments are cleaned and sterile and that the appropriate eye is marked for surgery.

“I put a ‘yes’ or ‘no’ over each eye … and on the microscope I put a note with the patient’s name, which surgery it is going to be and which eye you are working on,” he said. “The key here is if you keep to the details, then you will prevent many complications.”

Careful intraoperative steps reduce endophthalmitis risk

The incidence of endophthalmitis after cataract surgery is low, but in the past decade it has increased, and surgeons must take careful intraoperative steps to reduce the risk of sight-threatening infection in their patients.

“You would think with all the advances in smaller incisions and greater technologies that endophthalmitis would be decreasing,” Dr. O’Brien said. “Using a Medicare database with 500,000 procedures, it was found that there was a significant rise (P < .05) in the incidence of endophthalmitis as we crossed into the millennium.”

Dr. O’Brien discussed approaches that surgeons can use to reduce the risk of endophthalmitis in their practices.

Some of the “time-honored” methods for reducing the risk of infection include using a skin preparation of 10% povidone-iodine scrub followed by a 5% povidone-iodine solution applied directly to the eye as an antiseptic, he said.

“The use of adhesive draping is also important,” Dr. O’Brien said.

Regarding wound closure, he said, “If you have any doubts, it is worth placing a suture. That costs a lot less than an endophthalmitis case.”

Anesthesiologist: Pain reduction important for cataract surgery

The technology of cataract surgery has come a long way since the time of couching, but even if surgeons are no longer removing cataractous lenses using sharpened sticks they still need to take care in “reducing the sting” for their patients, according to an anesthesiologist.

That “sting” — the intra- and postoperative pain experienced by patients — can be reduced with a variety of anesthetic approaches, including topical anesthesia, intravitreal anesthesia injection and general anesthesia, said Steven I. Gayer, MD, an associate professor of clinical anesthesiology at the University of Miami’s Leonard M. Miller School of Medicine.

“The advantage of topical anesthesia is that it is quick, simple and noninvasive, and the patient retains the ability to see,” Dr. Gayer said. “It is simple for uncomplicated or brief procedures where an experienced ophthalmologist is working in selected cooperative patients.”

In most cases, the first drop of topical anesthetic stings, so some surgeons dilute that first drop to reduce anesthesia-related pain for their patients, he said.

General anesthesia may be more appropriate for cataract surgery in patients with special needs, such as children, Dr. Gayer said. One advantage with general anesthesia is that patients do not experience the sting associated with topical anesthetics. But “regardless of their amount of discomfort, [these patients] will rub their eyes and cause disruption of the delicate surgery that you have just done,” he said.

Because of the risk of rubbing, Dr. Gayer suggested placing local diluted anesthetic before the patient’s emergence from general anesthesia. This will reduce sensation so that the patient is less likely to rub his or her eyes.

Pattern ERG useful for detecting early to moderate glaucoma

Retinal response measured with pattern electroretinogram may serve as a complementary diagnostic tool to detect early glaucoma, according to Lori Ventura, MD.

Pattern electroretinogram (PERG) is a retinal response test that directly and objectively measures retinal ganglion cell function, Dr. Ventura said. Instead of using a flash of light, as with a standard electroretinogram, PERG uses light and dark bars rapidly alternating at a frequency of 16 Hz to elicit a mass cell response, she said.

In studies, Dr. Ventura and colleagues at Bascom Palmer have shown that patients with apparently normal visual function may have abnormal structures that can be detected using PERG.

“The IOP threshold for damage to the retinal nerve fiber layer differs from patient to patient,” Dr. Ventura said. “There is no way for us to know what the true pressure threshold is. The cutoff of 21 mm Hg was a myth for open-angle glaucoma, and the targets we establish in our day-to-day practices are based on assumptions that our patients … will match the profiles of studies done in the past,” she said.

PERG technology has been available for several years, but it has never been widely applied because it requires electrodes to be placed directly on the surface of the eye, Dr. Ventura said. Vittorio Porciatti, DSc, also a faculty member at Bascom Palmer, modified the device so that the electrodes can be placed on the skin, and now the test takes only 3 minutes, she said.

“PERG is not designed to replace visual field tests or optical coherence tomography,” she said. “All these tests provide complementary information to the clinician.”

IOP measurement paradigm shifting, surgeon says

Fluctuations in IOP are more accentuated in patients with glaucoma than in normal patients, and knowing when such peaks occur is important for controlling those fluctuations, according to a physician speaking here.

Felix Gil, MD, presented a possible new paradigm for better IOP monitoring in glaucoma patients.

“We take the IOP in our patients once or twice a year, and it takes 2 seconds. That represents exactly 2 seconds of the 86,400 seconds we have in a day,” Dr. Gil said through an interpreter. “So we are having a single spot-check, but what happens the rest of the day? We do not know, and this is part of our ignorance.”

Variations in pressure larger than 3 mm Hg should be seen as “red flags” Dr. Gil noted.

“What is important is not that the patient should reach 14 mm Hg just because that is a good pressure, but that 14 mm Hg is maintained plus or minus 3 mm Hg throughout the day. That is the paradigm shift,” he said.

The only way to control peaks of 3 mm Hg or more is to know when they happen, Dr. Gil said, and the only way to know when they happen is to measure IOP over 24 hours.

“These are the silent killers. These peaks occur when [patients] are not in office hours,” he said.

To estimate 24-hour IOP, Dr. Gil recommended measuring IOP at 1 a.m. and 6 a.m. while the patient is lying down and then at 9 a.m., 12 p.m., 3 p.m., 6 p.m., 9 p.m. and 11 p.m.

“Or I use the Barrone method, where the patient lies down, and I take pressures at 8 a.m. and 9 a.m. after 1 hour of resting,” he said. “This will give us 70% reproducibility in patients with glaucoma.”

Longer follow-up needed to demonstrate Avastin’s safety, investigator says

Bevacizumab seems safe for ophthalmic use in early studies published to date, but longer-term follow-up is needed, according to a physician.

Philip J. Rosenfeld

Regarding the safety of intravitreal use of the systemic anti-cancer drug, “The answer is, ‘we do not know,’” Philip J. Rosenfeld, MD, said. “But we are starting to learn a lot more about this molecule than we knew a year ago.”

Avastin (bevacizumab, Genentech) is a recombinant humanized antibody approved by the FDA for treating metastatic colorectal cancer, but ophthalmologists have begun using it off-label as a treatment for age-related macular degeneration in the past year, he said.

According to Dr. Rosenfeld, no toxicity issues have been found in early tissue cultures and in in vitro studies.

“It is nontoxic to cell cultures and nontoxic to explanted retinal tissue,” he said, noting that the drug has also been shown to be safe histopathologically and electrophysiologically.

“Surprisingly, when we inject this large antibody into the eye, we do not see inflammation,” he said. It appears that the systemic risks of Avastin are low, he added, citing a study published in the British Journal of Ophthalmology.

So far, the data published on Avastin’s use in AMD describe 2- to 3-month outcomes, and long-term studies are needed to determine its safety, Dr. Rosenfeld said.

“What this confirms is that over the short term, a snapshot of experience tells us that this appears to be safe,” he said. “But we do not know what the long-term consequences are.”

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• Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology, focusing on optics, refraction and contact lenses.